Trial Outcomes & Findings for Real-time Effort Driven VENTilator Management (NCT NCT03266016)
NCT ID: NCT03266016
Last Updated: 2025-09-17
Results Overview
Time from first attempted SBT until SBT passage or extubation \[whichever comes first\]
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
248 participants
Primary outcome timeframe
First 28 days of Mechanical Ventilation
Results posted on
2025-09-17
Participant Flow
Participant milestones
| Measure |
Acute: REDvent
Acute Phase: The acute phase is defined as the time from intubation until the patient meets weaning criteria, passes the initial oxygenation test (decrease PEEP to 5 cmH2O and FiO2 to 0.5, maintains SpO2 \> 90%), and undergoes a Spontaneous Breathing Trial (SBT). Patients will be managed with pressure control plus pressure support ventilation using a computerized decision support tool that will recommend changes to ventilator settings approximately every 4 hr (with or without a new blood gas). If the patient is spontaneously breathing, it will incorporate real-time measures of effort of breathing (esophageal manometry) to keep it in a target range.
Computerized Ventilator Protocol: Computerized Decision Support System which recommends changes to ventilator settings to promote physiologic levels of patient effort of breathing.
Esophageal Manometry: Esophageal Manometry Catheter to measure effort of breathing an transpulmonary pressure
Respiratory Inductance Plethysmography (RIP): RIP bands to measure thoraco-abdominal synchrony during spontaneous breathing trials
Diaphragm Ultrasound: Daily measurement of diaphragm thickness and diaphragm contractile activity
Maximal Inspiratory Pressure: Prior to Spontaneous breathing trials, measurement of airway and esophageal maximal inspiratory pressure during airway occlusion
|
Acute: Control
Acute Phase: The acute phase is defined as the time from intubation until the patient meets weaning criteria, passes the initial oxygenation test (decrease PEEP to 5 cmH2O and FiO2 to 0.5, maintains SpO2 \> 90%), and undergoes a Spontaneous Breathing Trial (SBT). Ventilator management will be per usual care until the patient meets weaning criteria and passes the oxygenation test.
Esophageal Manometry: Esophageal Manometry Catheter to measure effort of breathing an transpulmonary pressure
Respiratory Inductance Plethysmography (RIP): RIP bands to measure thoraco-abdominal synchrony during spontaneous breathing trials
Diaphragm Ultrasound: Daily measurement of diaphragm thickness and diaphragm contractile activity
Maximal Inspiratory Pressure: Prior to Spontaneous breathing trials, measurement of airway and esophageal maximal inspiratory pressure during airway occlusion
|
Weaning: Redvent
The weaning phase is defined as the time from the first SBT until the patient successfully passes an SBT. SBTs are performed daily during the weaning phase, along with measurement of PiMax with airway occlusion maneuvers. Patients will be managed in a PS/CPAP mode of ventilation and PRP will be monitored continuously, adjusting PS (to a max of 20 cmH20) every 4 h to maintain PRP in the target range. PEEP may be adjusted between 5 and 10 cmH20. Weaning phase intervention continues until extubation.
|
Weaning: Control
The weaning phase is defined as the time from the first SBT until the patient successfully passes an SBT. SBTs are performed daily during the weaning phase, along with measurement of PiMax with airway occlusion maneuvers. Ventilator management will be per usual care as determined by the treating clinical team until the patient is extubated.
|
|---|---|---|---|---|
|
Weaning Phase (0 to 28 Days)
STARTED
|
0
|
0
|
58
|
58
|
|
Acute Phase (0 to 28 Days)
STARTED
|
126
|
122
|
0
|
0
|
|
Acute Phase (0 to 28 Days)
Exited Study at Acute Phase
|
75
|
56
|
0
|
0
|
|
Acute Phase (0 to 28 Days)
COMPLETED
|
50
|
66
|
0
|
0
|
|
Acute Phase (0 to 28 Days)
NOT COMPLETED
|
76
|
56
|
0
|
0
|
|
Weaning Phase (0 to 28 Days)
COMPLETED
|
0
|
0
|
58
|
58
|
|
Weaning Phase (0 to 28 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Acute: REDvent
Acute Phase: The acute phase is defined as the time from intubation until the patient meets weaning criteria, passes the initial oxygenation test (decrease PEEP to 5 cmH2O and FiO2 to 0.5, maintains SpO2 \> 90%), and undergoes a Spontaneous Breathing Trial (SBT). Patients will be managed with pressure control plus pressure support ventilation using a computerized decision support tool that will recommend changes to ventilator settings approximately every 4 hr (with or without a new blood gas). If the patient is spontaneously breathing, it will incorporate real-time measures of effort of breathing (esophageal manometry) to keep it in a target range.
Computerized Ventilator Protocol: Computerized Decision Support System which recommends changes to ventilator settings to promote physiologic levels of patient effort of breathing.
Esophageal Manometry: Esophageal Manometry Catheter to measure effort of breathing an transpulmonary pressure
Respiratory Inductance Plethysmography (RIP): RIP bands to measure thoraco-abdominal synchrony during spontaneous breathing trials
Diaphragm Ultrasound: Daily measurement of diaphragm thickness and diaphragm contractile activity
Maximal Inspiratory Pressure: Prior to Spontaneous breathing trials, measurement of airway and esophageal maximal inspiratory pressure during airway occlusion
|
Acute: Control
Acute Phase: The acute phase is defined as the time from intubation until the patient meets weaning criteria, passes the initial oxygenation test (decrease PEEP to 5 cmH2O and FiO2 to 0.5, maintains SpO2 \> 90%), and undergoes a Spontaneous Breathing Trial (SBT). Ventilator management will be per usual care until the patient meets weaning criteria and passes the oxygenation test.
Esophageal Manometry: Esophageal Manometry Catheter to measure effort of breathing an transpulmonary pressure
Respiratory Inductance Plethysmography (RIP): RIP bands to measure thoraco-abdominal synchrony during spontaneous breathing trials
Diaphragm Ultrasound: Daily measurement of diaphragm thickness and diaphragm contractile activity
Maximal Inspiratory Pressure: Prior to Spontaneous breathing trials, measurement of airway and esophageal maximal inspiratory pressure during airway occlusion
|
Weaning: Redvent
The weaning phase is defined as the time from the first SBT until the patient successfully passes an SBT. SBTs are performed daily during the weaning phase, along with measurement of PiMax with airway occlusion maneuvers. Patients will be managed in a PS/CPAP mode of ventilation and PRP will be monitored continuously, adjusting PS (to a max of 20 cmH20) every 4 h to maintain PRP in the target range. PEEP may be adjusted between 5 and 10 cmH20. Weaning phase intervention continues until extubation.
|
Weaning: Control
The weaning phase is defined as the time from the first SBT until the patient successfully passes an SBT. SBTs are performed daily during the weaning phase, along with measurement of PiMax with airway occlusion maneuvers. Ventilator management will be per usual care as determined by the treating clinical team until the patient is extubated.
|
|---|---|---|---|---|
|
Acute Phase (0 to 28 Days)
Withdrawal by Subject
|
1
|
0
|
0
|
0
|
|
Acute Phase (0 to 28 Days)
Completed study at acute phase.
|
75
|
56
|
0
|
0
|
Baseline Characteristics
All patients entered acute phase of study (n=247). Patients that passed first spontaneous breathing trial or were extubated successfully ended the study at the acute phase (n=131). This left 116 patients who were randomized to the weaning phase intervention.
Baseline characteristics by cohort
| Measure |
Acute: REDvent
n=125 Participants
Acute Phase: The acute phase is defined as the time from intubation until the patient meets weaning criteria, passes the initial oxygenation test (decrease PEEP to 5 cmH2O and FiO2 to 0.5, maintains SpO2 \> 90%), and undergoes a Spontaneous Breathing Trial (SBT). Patients will be managed with pressure control plus pressure support ventilation using a computerized decision support tool that will recommend changes to ventilator settings approximately every 4 hr (with or without a new blood gas). If the patient is spontaneously breathing, it will incorporate real-time measures of effort of breathing (esophageal manometry) to keep it in a target range.
Computerized Ventilator Protocol: Computerized Decision Support System which recommends changes to ventilator settings to promote physiologic levels of patient effort of breathing.
Esophageal Manometry: Esophageal Manometry Catheter to measure effort of breathing an transpulmonary pressure
Respiratory Inductance Plethysmography (RIP): RIP bands to measure thoraco-abdominal synchrony during spontaneous breathing trials
Diaphragm Ultrasound: Daily measurement of diaphragm thickness and diaphragm contractile activity
Maximal Inspiratory Pressure: Prior to Spontaneous breathing trials, measurement of airway and esophageal maximal inspiratory pressure during airway occlusion
|
Acute: Control
n=122 Participants
Acute Phase: The acute phase is defined as the time from intubation until the patient meets weaning criteria, passes the initial oxygenation test (decrease PEEP to 5 cmH2O and FiO2 to 0.5, maintains SpO2 \> 90%), and undergoes a Spontaneous Breathing Trial (SBT). Ventilator management will be per usual care until the patient meets weaning criteria and passes the oxygenation test.
Esophageal Manometry: Esophageal Manometry Catheter to measure effort of breathing an transpulmonary pressure
Respiratory Inductance Plethysmography (RIP): RIP bands to measure thoraco-abdominal synchrony during spontaneous breathing trials
Diaphragm Ultrasound: Daily measurement of diaphragm thickness and diaphragm contractile activity
Maximal Inspiratory Pressure: Prior to Spontaneous breathing trials, measurement of airway and esophageal maximal inspiratory pressure during airway occlusion
|
Weaning: Redvent
The weaning phase is defined as the time from the first SBT until the patient successfully passes an SBT. SBTs are performed daily during the weaning phase, along with measurement of PiMax with airway occlusion maneuvers. Patients will be managed in a PS/CPAP mode of ventilation and PRP will be monitored continuously, adjusting PS (to a max of 20 cmH20) every 4 h to maintain PRP in the target range. PEEP may be adjusted between 5 and 10 cmH20. Weaning phase intervention continues until extubation.
|
Weaning: Control
The weaning phase is defined as the time from the first SBT until the patient successfully passes an SBT. SBTs are performed daily during the weaning phase, along with measurement of PiMax with airway occlusion maneuvers. Ventilator management will be per usual care as determined by the treating clinical team until the patient is extubated.
|
Total
n=247 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
Acute Phase Randomization · <=18 years
|
120 Participants
n=99 Participants • All patients entered acute phase of study (n=247). Patients that passed first spontaneous breathing trial or were extubated successfully ended the study at the acute phase (n=131). This left 116 patients who were randomized to the weaning phase intervention.
|
117 Participants
n=107 Participants • All patients entered acute phase of study (n=247). Patients that passed first spontaneous breathing trial or were extubated successfully ended the study at the acute phase (n=131). This left 116 patients who were randomized to the weaning phase intervention.
|
0 Participants
n=206 Participants • All patients entered acute phase of study (n=247). Patients that passed first spontaneous breathing trial or were extubated successfully ended the study at the acute phase (n=131). This left 116 patients who were randomized to the weaning phase intervention.
|
0 Participants
n=7 Participants • All patients entered acute phase of study (n=247). Patients that passed first spontaneous breathing trial or were extubated successfully ended the study at the acute phase (n=131). This left 116 patients who were randomized to the weaning phase intervention.
|
237 Participants
n=31 Participants • All patients entered acute phase of study (n=247). Patients that passed first spontaneous breathing trial or were extubated successfully ended the study at the acute phase (n=131). This left 116 patients who were randomized to the weaning phase intervention.
|
|
Age, Categorical
Acute Phase Randomization · Between 18 and 65 years
|
5 Participants
n=99 Participants • All patients entered acute phase of study (n=247). Patients that passed first spontaneous breathing trial or were extubated successfully ended the study at the acute phase (n=131). This left 116 patients who were randomized to the weaning phase intervention.
|
5 Participants
n=107 Participants • All patients entered acute phase of study (n=247). Patients that passed first spontaneous breathing trial or were extubated successfully ended the study at the acute phase (n=131). This left 116 patients who were randomized to the weaning phase intervention.
|
0 Participants
n=206 Participants • All patients entered acute phase of study (n=247). Patients that passed first spontaneous breathing trial or were extubated successfully ended the study at the acute phase (n=131). This left 116 patients who were randomized to the weaning phase intervention.
|
0 Participants
n=7 Participants • All patients entered acute phase of study (n=247). Patients that passed first spontaneous breathing trial or were extubated successfully ended the study at the acute phase (n=131). This left 116 patients who were randomized to the weaning phase intervention.
|
10 Participants
n=31 Participants • All patients entered acute phase of study (n=247). Patients that passed first spontaneous breathing trial or were extubated successfully ended the study at the acute phase (n=131). This left 116 patients who were randomized to the weaning phase intervention.
|
|
Age, Categorical
Acute Phase Randomization · >=65 years
|
0 Participants
n=99 Participants • All patients entered acute phase of study (n=247). Patients that passed first spontaneous breathing trial or were extubated successfully ended the study at the acute phase (n=131). This left 116 patients who were randomized to the weaning phase intervention.
|
0 Participants
n=107 Participants • All patients entered acute phase of study (n=247). Patients that passed first spontaneous breathing trial or were extubated successfully ended the study at the acute phase (n=131). This left 116 patients who were randomized to the weaning phase intervention.
|
0 Participants
n=206 Participants • All patients entered acute phase of study (n=247). Patients that passed first spontaneous breathing trial or were extubated successfully ended the study at the acute phase (n=131). This left 116 patients who were randomized to the weaning phase intervention.
|
0 Participants
n=7 Participants • All patients entered acute phase of study (n=247). Patients that passed first spontaneous breathing trial or were extubated successfully ended the study at the acute phase (n=131). This left 116 patients who were randomized to the weaning phase intervention.
|
0 Participants
n=31 Participants • All patients entered acute phase of study (n=247). Patients that passed first spontaneous breathing trial or were extubated successfully ended the study at the acute phase (n=131). This left 116 patients who were randomized to the weaning phase intervention.
|
|
Age, Continuous
Acute Phase Randomization
|
5.9 years
n=99 Participants • Measure Analysis Population Description: All patients entered acute phase of study (n=247). Patients that passed first spontaneous breathing trial or were extubated successfully ended the study at the acute phase (n=131). This left 116 patients who were randomized to the weaning phase intervention.
|
4.9 years
n=107 Participants • Measure Analysis Population Description: All patients entered acute phase of study (n=247). Patients that passed first spontaneous breathing trial or were extubated successfully ended the study at the acute phase (n=131). This left 116 patients who were randomized to the weaning phase intervention.
|
—
|
—
|
5.6 years
n=31 Participants • Measure Analysis Population Description: All patients entered acute phase of study (n=247). Patients that passed first spontaneous breathing trial or were extubated successfully ended the study at the acute phase (n=131). This left 116 patients who were randomized to the weaning phase intervention.
|
|
Age, Customized
Acute Phase Randomization · Infant
|
20 Participants
n=99 Participants • Measure Analysis Population Description: Measure Analysis Population Description: All patients entered acute phase of study (n=247). Patients that passed first spontaneous breathing trial or were extubated successfully ended the study at the acute phase (n=131). This left 116 patients who were randomized to the weaning phase intervention.
|
21 Participants
n=107 Participants • Measure Analysis Population Description: Measure Analysis Population Description: All patients entered acute phase of study (n=247). Patients that passed first spontaneous breathing trial or were extubated successfully ended the study at the acute phase (n=131). This left 116 patients who were randomized to the weaning phase intervention.
|
0 Participants
n=206 Participants • Measure Analysis Population Description: Measure Analysis Population Description: All patients entered acute phase of study (n=247). Patients that passed first spontaneous breathing trial or were extubated successfully ended the study at the acute phase (n=131). This left 116 patients who were randomized to the weaning phase intervention.
|
0 Participants
n=7 Participants • Measure Analysis Population Description: Measure Analysis Population Description: All patients entered acute phase of study (n=247). Patients that passed first spontaneous breathing trial or were extubated successfully ended the study at the acute phase (n=131). This left 116 patients who were randomized to the weaning phase intervention.
|
41 Participants
n=31 Participants • Measure Analysis Population Description: Measure Analysis Population Description: All patients entered acute phase of study (n=247). Patients that passed first spontaneous breathing trial or were extubated successfully ended the study at the acute phase (n=131). This left 116 patients who were randomized to the weaning phase intervention.
|
|
Age, Customized
Acute Phase Randomization · Child
|
60 Participants
n=99 Participants • Measure Analysis Population Description: Measure Analysis Population Description: All patients entered acute phase of study (n=247). Patients that passed first spontaneous breathing trial or were extubated successfully ended the study at the acute phase (n=131). This left 116 patients who were randomized to the weaning phase intervention.
|
59 Participants
n=107 Participants • Measure Analysis Population Description: Measure Analysis Population Description: All patients entered acute phase of study (n=247). Patients that passed first spontaneous breathing trial or were extubated successfully ended the study at the acute phase (n=131). This left 116 patients who were randomized to the weaning phase intervention.
|
0 Participants
n=206 Participants • Measure Analysis Population Description: Measure Analysis Population Description: All patients entered acute phase of study (n=247). Patients that passed first spontaneous breathing trial or were extubated successfully ended the study at the acute phase (n=131). This left 116 patients who were randomized to the weaning phase intervention.
|
0 Participants
n=7 Participants • Measure Analysis Population Description: Measure Analysis Population Description: All patients entered acute phase of study (n=247). Patients that passed first spontaneous breathing trial or were extubated successfully ended the study at the acute phase (n=131). This left 116 patients who were randomized to the weaning phase intervention.
|
119 Participants
n=31 Participants • Measure Analysis Population Description: Measure Analysis Population Description: All patients entered acute phase of study (n=247). Patients that passed first spontaneous breathing trial or were extubated successfully ended the study at the acute phase (n=131). This left 116 patients who were randomized to the weaning phase intervention.
|
|
Age, Customized
Acute Phase Randomization · Adolescents
|
45 Participants
n=99 Participants • Measure Analysis Population Description: Measure Analysis Population Description: All patients entered acute phase of study (n=247). Patients that passed first spontaneous breathing trial or were extubated successfully ended the study at the acute phase (n=131). This left 116 patients who were randomized to the weaning phase intervention.
|
42 Participants
n=107 Participants • Measure Analysis Population Description: Measure Analysis Population Description: All patients entered acute phase of study (n=247). Patients that passed first spontaneous breathing trial or were extubated successfully ended the study at the acute phase (n=131). This left 116 patients who were randomized to the weaning phase intervention.
|
0 Participants
n=206 Participants • Measure Analysis Population Description: Measure Analysis Population Description: All patients entered acute phase of study (n=247). Patients that passed first spontaneous breathing trial or were extubated successfully ended the study at the acute phase (n=131). This left 116 patients who were randomized to the weaning phase intervention.
|
0 Participants
n=7 Participants • Measure Analysis Population Description: Measure Analysis Population Description: All patients entered acute phase of study (n=247). Patients that passed first spontaneous breathing trial or were extubated successfully ended the study at the acute phase (n=131). This left 116 patients who were randomized to the weaning phase intervention.
|
87 Participants
n=31 Participants • Measure Analysis Population Description: Measure Analysis Population Description: All patients entered acute phase of study (n=247). Patients that passed first spontaneous breathing trial or were extubated successfully ended the study at the acute phase (n=131). This left 116 patients who were randomized to the weaning phase intervention.
|
|
Sex: Female, Male
Acute Phase Randomization · Female
|
54 Participants
n=99 Participants • Measure Analysis Population Description: All patients entered acute phase of study (n=247). Patients that passed first spontaneous breathing trial or were extubated successfully ended the study at the acute phase (n=131). This left 116 patients who were randomized to the weaning phase intervention.
|
61 Participants
n=107 Participants • Measure Analysis Population Description: All patients entered acute phase of study (n=247). Patients that passed first spontaneous breathing trial or were extubated successfully ended the study at the acute phase (n=131). This left 116 patients who were randomized to the weaning phase intervention.
|
0 Participants
n=206 Participants • Measure Analysis Population Description: All patients entered acute phase of study (n=247). Patients that passed first spontaneous breathing trial or were extubated successfully ended the study at the acute phase (n=131). This left 116 patients who were randomized to the weaning phase intervention.
|
0 Participants
n=7 Participants • Measure Analysis Population Description: All patients entered acute phase of study (n=247). Patients that passed first spontaneous breathing trial or were extubated successfully ended the study at the acute phase (n=131). This left 116 patients who were randomized to the weaning phase intervention.
|
115 Participants
n=31 Participants • Measure Analysis Population Description: All patients entered acute phase of study (n=247). Patients that passed first spontaneous breathing trial or were extubated successfully ended the study at the acute phase (n=131). This left 116 patients who were randomized to the weaning phase intervention.
|
|
Sex: Female, Male
Acute Phase Randomization · Male
|
71 Participants
n=99 Participants • Measure Analysis Population Description: All patients entered acute phase of study (n=247). Patients that passed first spontaneous breathing trial or were extubated successfully ended the study at the acute phase (n=131). This left 116 patients who were randomized to the weaning phase intervention.
|
61 Participants
n=107 Participants • Measure Analysis Population Description: All patients entered acute phase of study (n=247). Patients that passed first spontaneous breathing trial or were extubated successfully ended the study at the acute phase (n=131). This left 116 patients who were randomized to the weaning phase intervention.
|
0 Participants
n=206 Participants • Measure Analysis Population Description: All patients entered acute phase of study (n=247). Patients that passed first spontaneous breathing trial or were extubated successfully ended the study at the acute phase (n=131). This left 116 patients who were randomized to the weaning phase intervention.
|
0 Participants
n=7 Participants • Measure Analysis Population Description: All patients entered acute phase of study (n=247). Patients that passed first spontaneous breathing trial or were extubated successfully ended the study at the acute phase (n=131). This left 116 patients who were randomized to the weaning phase intervention.
|
132 Participants
n=31 Participants • Measure Analysis Population Description: All patients entered acute phase of study (n=247). Patients that passed first spontaneous breathing trial or were extubated successfully ended the study at the acute phase (n=131). This left 116 patients who were randomized to the weaning phase intervention.
|
|
Ethnicity (NIH/OMB)
Acute Phase Randomization · Hispanic or Latino
|
72 Participants
n=99 Participants • Measure Analysis Population Description: All patients entered acute phase of study (n=247). Patients that passed first spontaneous breathing trial or were extubated successfully ended the study at the acute phase (n=131). This left 116 patients who were randomized to the weaning phase intervention.
|
84 Participants
n=107 Participants • Measure Analysis Population Description: All patients entered acute phase of study (n=247). Patients that passed first spontaneous breathing trial or were extubated successfully ended the study at the acute phase (n=131). This left 116 patients who were randomized to the weaning phase intervention.
|
0 Participants
n=206 Participants • Measure Analysis Population Description: All patients entered acute phase of study (n=247). Patients that passed first spontaneous breathing trial or were extubated successfully ended the study at the acute phase (n=131). This left 116 patients who were randomized to the weaning phase intervention.
|
0 Participants
n=7 Participants • Measure Analysis Population Description: All patients entered acute phase of study (n=247). Patients that passed first spontaneous breathing trial or were extubated successfully ended the study at the acute phase (n=131). This left 116 patients who were randomized to the weaning phase intervention.
|
156 Participants
n=31 Participants • Measure Analysis Population Description: All patients entered acute phase of study (n=247). Patients that passed first spontaneous breathing trial or were extubated successfully ended the study at the acute phase (n=131). This left 116 patients who were randomized to the weaning phase intervention.
|
|
Ethnicity (NIH/OMB)
Acute Phase Randomization · Not Hispanic or Latino
|
43 Participants
n=99 Participants • Measure Analysis Population Description: All patients entered acute phase of study (n=247). Patients that passed first spontaneous breathing trial or were extubated successfully ended the study at the acute phase (n=131). This left 116 patients who were randomized to the weaning phase intervention.
|
32 Participants
n=107 Participants • Measure Analysis Population Description: All patients entered acute phase of study (n=247). Patients that passed first spontaneous breathing trial or were extubated successfully ended the study at the acute phase (n=131). This left 116 patients who were randomized to the weaning phase intervention.
|
0 Participants
n=206 Participants • Measure Analysis Population Description: All patients entered acute phase of study (n=247). Patients that passed first spontaneous breathing trial or were extubated successfully ended the study at the acute phase (n=131). This left 116 patients who were randomized to the weaning phase intervention.
|
0 Participants
n=7 Participants • Measure Analysis Population Description: All patients entered acute phase of study (n=247). Patients that passed first spontaneous breathing trial or were extubated successfully ended the study at the acute phase (n=131). This left 116 patients who were randomized to the weaning phase intervention.
|
75 Participants
n=31 Participants • Measure Analysis Population Description: All patients entered acute phase of study (n=247). Patients that passed first spontaneous breathing trial or were extubated successfully ended the study at the acute phase (n=131). This left 116 patients who were randomized to the weaning phase intervention.
|
|
Ethnicity (NIH/OMB)
Acute Phase Randomization · Unknown or Not Reported
|
10 Participants
n=99 Participants • Measure Analysis Population Description: All patients entered acute phase of study (n=247). Patients that passed first spontaneous breathing trial or were extubated successfully ended the study at the acute phase (n=131). This left 116 patients who were randomized to the weaning phase intervention.
|
6 Participants
n=107 Participants • Measure Analysis Population Description: All patients entered acute phase of study (n=247). Patients that passed first spontaneous breathing trial or were extubated successfully ended the study at the acute phase (n=131). This left 116 patients who were randomized to the weaning phase intervention.
|
0 Participants
n=206 Participants • Measure Analysis Population Description: All patients entered acute phase of study (n=247). Patients that passed first spontaneous breathing trial or were extubated successfully ended the study at the acute phase (n=131). This left 116 patients who were randomized to the weaning phase intervention.
|
0 Participants
n=7 Participants • Measure Analysis Population Description: All patients entered acute phase of study (n=247). Patients that passed first spontaneous breathing trial or were extubated successfully ended the study at the acute phase (n=131). This left 116 patients who were randomized to the weaning phase intervention.
|
16 Participants
n=31 Participants • Measure Analysis Population Description: All patients entered acute phase of study (n=247). Patients that passed first spontaneous breathing trial or were extubated successfully ended the study at the acute phase (n=131). This left 116 patients who were randomized to the weaning phase intervention.
|
|
Race (NIH/OMB)
Acute Phase Randomization · American Indian or Alaska Native
|
0 Participants
n=99 Participants • Measure Analysis Population Description: All patients entered acute phase of study (n=247). Patients that passed first spontaneous breathing trial or were extubated successfully ended the study at the acute phase (n=131). This left 116 patients who were randomized to the weaning phase intervention.
|
0 Participants
n=107 Participants • Measure Analysis Population Description: All patients entered acute phase of study (n=247). Patients that passed first spontaneous breathing trial or were extubated successfully ended the study at the acute phase (n=131). This left 116 patients who were randomized to the weaning phase intervention.
|
0 Participants
n=206 Participants • Measure Analysis Population Description: All patients entered acute phase of study (n=247). Patients that passed first spontaneous breathing trial or were extubated successfully ended the study at the acute phase (n=131). This left 116 patients who were randomized to the weaning phase intervention.
|
0 Participants
n=7 Participants • Measure Analysis Population Description: All patients entered acute phase of study (n=247). Patients that passed first spontaneous breathing trial or were extubated successfully ended the study at the acute phase (n=131). This left 116 patients who were randomized to the weaning phase intervention.
|
0 Participants
n=31 Participants • Measure Analysis Population Description: All patients entered acute phase of study (n=247). Patients that passed first spontaneous breathing trial or were extubated successfully ended the study at the acute phase (n=131). This left 116 patients who were randomized to the weaning phase intervention.
|
|
Race (NIH/OMB)
Acute Phase Randomization · Asian
|
8 Participants
n=99 Participants • Measure Analysis Population Description: All patients entered acute phase of study (n=247). Patients that passed first spontaneous breathing trial or were extubated successfully ended the study at the acute phase (n=131). This left 116 patients who were randomized to the weaning phase intervention.
|
3 Participants
n=107 Participants • Measure Analysis Population Description: All patients entered acute phase of study (n=247). Patients that passed first spontaneous breathing trial or were extubated successfully ended the study at the acute phase (n=131). This left 116 patients who were randomized to the weaning phase intervention.
|
0 Participants
n=206 Participants • Measure Analysis Population Description: All patients entered acute phase of study (n=247). Patients that passed first spontaneous breathing trial or were extubated successfully ended the study at the acute phase (n=131). This left 116 patients who were randomized to the weaning phase intervention.
|
0 Participants
n=7 Participants • Measure Analysis Population Description: All patients entered acute phase of study (n=247). Patients that passed first spontaneous breathing trial or were extubated successfully ended the study at the acute phase (n=131). This left 116 patients who were randomized to the weaning phase intervention.
|
11 Participants
n=31 Participants • Measure Analysis Population Description: All patients entered acute phase of study (n=247). Patients that passed first spontaneous breathing trial or were extubated successfully ended the study at the acute phase (n=131). This left 116 patients who were randomized to the weaning phase intervention.
|
|
Race (NIH/OMB)
Acute Phase Randomization · Native Hawaiian or Other Pacific Islander
|
1 Participants
n=99 Participants • Measure Analysis Population Description: All patients entered acute phase of study (n=247). Patients that passed first spontaneous breathing trial or were extubated successfully ended the study at the acute phase (n=131). This left 116 patients who were randomized to the weaning phase intervention.
|
5 Participants
n=107 Participants • Measure Analysis Population Description: All patients entered acute phase of study (n=247). Patients that passed first spontaneous breathing trial or were extubated successfully ended the study at the acute phase (n=131). This left 116 patients who were randomized to the weaning phase intervention.
|
0 Participants
n=206 Participants • Measure Analysis Population Description: All patients entered acute phase of study (n=247). Patients that passed first spontaneous breathing trial or were extubated successfully ended the study at the acute phase (n=131). This left 116 patients who were randomized to the weaning phase intervention.
|
0 Participants
n=7 Participants • Measure Analysis Population Description: All patients entered acute phase of study (n=247). Patients that passed first spontaneous breathing trial or were extubated successfully ended the study at the acute phase (n=131). This left 116 patients who were randomized to the weaning phase intervention.
|
6 Participants
n=31 Participants • Measure Analysis Population Description: All patients entered acute phase of study (n=247). Patients that passed first spontaneous breathing trial or were extubated successfully ended the study at the acute phase (n=131). This left 116 patients who were randomized to the weaning phase intervention.
|
|
Race (NIH/OMB)
Acute Phase Randomization · Black or African American
|
11 Participants
n=99 Participants • Measure Analysis Population Description: All patients entered acute phase of study (n=247). Patients that passed first spontaneous breathing trial or were extubated successfully ended the study at the acute phase (n=131). This left 116 patients who were randomized to the weaning phase intervention.
|
8 Participants
n=107 Participants • Measure Analysis Population Description: All patients entered acute phase of study (n=247). Patients that passed first spontaneous breathing trial or were extubated successfully ended the study at the acute phase (n=131). This left 116 patients who were randomized to the weaning phase intervention.
|
0 Participants
n=206 Participants • Measure Analysis Population Description: All patients entered acute phase of study (n=247). Patients that passed first spontaneous breathing trial or were extubated successfully ended the study at the acute phase (n=131). This left 116 patients who were randomized to the weaning phase intervention.
|
0 Participants
n=7 Participants • Measure Analysis Population Description: All patients entered acute phase of study (n=247). Patients that passed first spontaneous breathing trial or were extubated successfully ended the study at the acute phase (n=131). This left 116 patients who were randomized to the weaning phase intervention.
|
19 Participants
n=31 Participants • Measure Analysis Population Description: All patients entered acute phase of study (n=247). Patients that passed first spontaneous breathing trial or were extubated successfully ended the study at the acute phase (n=131). This left 116 patients who were randomized to the weaning phase intervention.
|
|
Race (NIH/OMB)
Acute Phase Randomization · White
|
32 Participants
n=99 Participants • Measure Analysis Population Description: All patients entered acute phase of study (n=247). Patients that passed first spontaneous breathing trial or were extubated successfully ended the study at the acute phase (n=131). This left 116 patients who were randomized to the weaning phase intervention.
|
24 Participants
n=107 Participants • Measure Analysis Population Description: All patients entered acute phase of study (n=247). Patients that passed first spontaneous breathing trial or were extubated successfully ended the study at the acute phase (n=131). This left 116 patients who were randomized to the weaning phase intervention.
|
0 Participants
n=206 Participants • Measure Analysis Population Description: All patients entered acute phase of study (n=247). Patients that passed first spontaneous breathing trial or were extubated successfully ended the study at the acute phase (n=131). This left 116 patients who were randomized to the weaning phase intervention.
|
0 Participants
n=7 Participants • Measure Analysis Population Description: All patients entered acute phase of study (n=247). Patients that passed first spontaneous breathing trial or were extubated successfully ended the study at the acute phase (n=131). This left 116 patients who were randomized to the weaning phase intervention.
|
56 Participants
n=31 Participants • Measure Analysis Population Description: All patients entered acute phase of study (n=247). Patients that passed first spontaneous breathing trial or were extubated successfully ended the study at the acute phase (n=131). This left 116 patients who were randomized to the weaning phase intervention.
|
|
Race (NIH/OMB)
Acute Phase Randomization · More than one race
|
1 Participants
n=99 Participants • Measure Analysis Population Description: All patients entered acute phase of study (n=247). Patients that passed first spontaneous breathing trial or were extubated successfully ended the study at the acute phase (n=131). This left 116 patients who were randomized to the weaning phase intervention.
|
2 Participants
n=107 Participants • Measure Analysis Population Description: All patients entered acute phase of study (n=247). Patients that passed first spontaneous breathing trial or were extubated successfully ended the study at the acute phase (n=131). This left 116 patients who were randomized to the weaning phase intervention.
|
0 Participants
n=206 Participants • Measure Analysis Population Description: All patients entered acute phase of study (n=247). Patients that passed first spontaneous breathing trial or were extubated successfully ended the study at the acute phase (n=131). This left 116 patients who were randomized to the weaning phase intervention.
|
0 Participants
n=7 Participants • Measure Analysis Population Description: All patients entered acute phase of study (n=247). Patients that passed first spontaneous breathing trial or were extubated successfully ended the study at the acute phase (n=131). This left 116 patients who were randomized to the weaning phase intervention.
|
3 Participants
n=31 Participants • Measure Analysis Population Description: All patients entered acute phase of study (n=247). Patients that passed first spontaneous breathing trial or were extubated successfully ended the study at the acute phase (n=131). This left 116 patients who were randomized to the weaning phase intervention.
|
|
Race (NIH/OMB)
Acute Phase Randomization · Unknown or Not Reported
|
72 Participants
n=99 Participants • Measure Analysis Population Description: All patients entered acute phase of study (n=247). Patients that passed first spontaneous breathing trial or were extubated successfully ended the study at the acute phase (n=131). This left 116 patients who were randomized to the weaning phase intervention.
|
80 Participants
n=107 Participants • Measure Analysis Population Description: All patients entered acute phase of study (n=247). Patients that passed first spontaneous breathing trial or were extubated successfully ended the study at the acute phase (n=131). This left 116 patients who were randomized to the weaning phase intervention.
|
0 Participants
n=206 Participants • Measure Analysis Population Description: All patients entered acute phase of study (n=247). Patients that passed first spontaneous breathing trial or were extubated successfully ended the study at the acute phase (n=131). This left 116 patients who were randomized to the weaning phase intervention.
|
0 Participants
n=7 Participants • Measure Analysis Population Description: All patients entered acute phase of study (n=247). Patients that passed first spontaneous breathing trial or were extubated successfully ended the study at the acute phase (n=131). This left 116 patients who were randomized to the weaning phase intervention.
|
152 Participants
n=31 Participants • Measure Analysis Population Description: All patients entered acute phase of study (n=247). Patients that passed first spontaneous breathing trial or were extubated successfully ended the study at the acute phase (n=131). This left 116 patients who were randomized to the weaning phase intervention.
|
|
Region of Enrollment
United States
|
125 participants
n=99 Participants
|
122 participants
n=107 Participants
|
—
|
—
|
247 participants
n=31 Participants
|
|
Number of Participants with Immunosuppression
|
35 Participants
n=99 Participants • Measure Analysis Population Description: All patients entered acute phase of study (n=247). Patients that passed first spontaneous breathing trial or were extubated successfully ended the study at the acute phase (n=131). This left 116 patients who were randomized to the weaning phase intervention.
|
33 Participants
n=107 Participants • Measure Analysis Population Description: All patients entered acute phase of study (n=247). Patients that passed first spontaneous breathing trial or were extubated successfully ended the study at the acute phase (n=131). This left 116 patients who were randomized to the weaning phase intervention.
|
0 Participants
n=206 Participants • Measure Analysis Population Description: All patients entered acute phase of study (n=247). Patients that passed first spontaneous breathing trial or were extubated successfully ended the study at the acute phase (n=131). This left 116 patients who were randomized to the weaning phase intervention.
|
0 Participants
n=7 Participants • Measure Analysis Population Description: All patients entered acute phase of study (n=247). Patients that passed first spontaneous breathing trial or were extubated successfully ended the study at the acute phase (n=131). This left 116 patients who were randomized to the weaning phase intervention.
|
68 Participants
n=31 Participants • Measure Analysis Population Description: All patients entered acute phase of study (n=247). Patients that passed first spontaneous breathing trial or were extubated successfully ended the study at the acute phase (n=131). This left 116 patients who were randomized to the weaning phase intervention.
|
PRIMARY outcome
Timeframe: First 28 days of Mechanical VentilationPopulation: Measure Analysis Population Description: All patients entered acute phase of study (n=247). Patients were eligible for the primary outcome of length of weaning if they had a spontaneous breathing trial attempted (n=215). Patients that passed first spontaneous breathing trial or were extubated successfully ended the study at the acute phase (n=131). This left 116 patients who were randomized to the weaning phase intervention.
Time from first attempted SBT until SBT passage or extubation \[whichever comes first\]
Outcome measures
| Measure |
Acute: REDvent
n=109 Participants
Acute Phase: The acute phase is defined as the time from intubation until the patient meets weaning criteria, passes the initial oxygenation test (decrease PEEP to 5 cmH2O and FiO2 to 0.5, maintains SpO2 \> 90%), and undergoes a Spontaneous Breathing Trial (SBT). Patients will be managed with pressure control plus pressure support ventilation using a computerized decision support tool that will recommend changes to ventilator settings approximately every 4 hr (with or without a new blood gas). If the patient is spontaneously breathing, it will incorporate real-time measures of effort of breathing (esophageal manometry) to keep it in a target range.
Computerized Ventilator Protocol: Computerized Decision Support System which recommends changes to ventilator settings to promote physiologic levels of patient effort of breathing.
Esophageal Manometry: Esophageal Manometry Catheter to measure effort of breathing an transpulmonary pressure
Respiratory Inductance Plethysmography (RIP): RIP bands to measure thoraco-abdominal synchrony during spontaneous breathing trials
Diaphragm Ultrasound: Daily measurement of diaphragm thickness and diaphragm contractile activity
Maximal Inspiratory Pressure: Prior to Spontaneous breathing trials, measurement of airway and esophageal maximal inspiratory pressure during airway occlusion
|
Acute: Control
n=106 Participants
Acute Phase: The acute phase is defined as the time from intubation until the patient meets weaning criteria, passes the initial oxygenation test (decrease PEEP to 5 cmH2O and FiO2 to 0.5, maintains SpO2 \> 90%), and undergoes a Spontaneous Breathing Trial (SBT). Ventilator management will be per usual care until the patient meets weaning criteria and passes the oxygenation test.
Esophageal Manometry: Esophageal Manometry Catheter to measure effort of breathing an transpulmonary pressure
Respiratory Inductance Plethysmography (RIP): RIP bands to measure thoraco-abdominal synchrony during spontaneous breathing trials
Diaphragm Ultrasound: Daily measurement of diaphragm thickness and diaphragm contractile activity
Maximal Inspiratory Pressure: Prior to Spontaneous breathing trials, measurement of airway and esophageal maximal inspiratory pressure during airway occlusion
|
|---|---|---|
|
Median Duration of Weaning
Acute
|
0.09 days
Interval 0.08 to 2.03
|
1.04 days
Interval 0.08 to 2.17
|
|
Median Duration of Weaning
Weaning
|
2.03 days
Interval 1.09 to 3.58
|
2.10 days
Interval 1.08 to 4.05
|
SECONDARY outcome
Timeframe: 28 daysDays alive and not on mechanical ventilation
Outcome measures
| Measure |
Acute: REDvent
n=125 Participants
Acute Phase: The acute phase is defined as the time from intubation until the patient meets weaning criteria, passes the initial oxygenation test (decrease PEEP to 5 cmH2O and FiO2 to 0.5, maintains SpO2 \> 90%), and undergoes a Spontaneous Breathing Trial (SBT). Patients will be managed with pressure control plus pressure support ventilation using a computerized decision support tool that will recommend changes to ventilator settings approximately every 4 hr (with or without a new blood gas). If the patient is spontaneously breathing, it will incorporate real-time measures of effort of breathing (esophageal manometry) to keep it in a target range.
Computerized Ventilator Protocol: Computerized Decision Support System which recommends changes to ventilator settings to promote physiologic levels of patient effort of breathing.
Esophageal Manometry: Esophageal Manometry Catheter to measure effort of breathing an transpulmonary pressure
Respiratory Inductance Plethysmography (RIP): RIP bands to measure thoraco-abdominal synchrony during spontaneous breathing trials
Diaphragm Ultrasound: Daily measurement of diaphragm thickness and diaphragm contractile activity
Maximal Inspiratory Pressure: Prior to Spontaneous breathing trials, measurement of airway and esophageal maximal inspiratory pressure during airway occlusion
|
Acute: Control
n=122 Participants
Acute Phase: The acute phase is defined as the time from intubation until the patient meets weaning criteria, passes the initial oxygenation test (decrease PEEP to 5 cmH2O and FiO2 to 0.5, maintains SpO2 \> 90%), and undergoes a Spontaneous Breathing Trial (SBT). Ventilator management will be per usual care until the patient meets weaning criteria and passes the oxygenation test.
Esophageal Manometry: Esophageal Manometry Catheter to measure effort of breathing an transpulmonary pressure
Respiratory Inductance Plethysmography (RIP): RIP bands to measure thoraco-abdominal synchrony during spontaneous breathing trials
Diaphragm Ultrasound: Daily measurement of diaphragm thickness and diaphragm contractile activity
Maximal Inspiratory Pressure: Prior to Spontaneous breathing trials, measurement of airway and esophageal maximal inspiratory pressure during airway occlusion
|
|---|---|---|
|
Median Ventilator Free Days Between Acute Phase Randomization Groups
|
21.9 days
Interval 14.0 to 24.5
|
21.3 days
Interval 14.2 to 23.9
|
SECONDARY outcome
Timeframe: Within 48 hours of extubation, assessed through study completion up to maximum of 90 DaysPopulation: Measure Analysis Population Description: All patients entered acute phase of study (n=247). 215 patients were eligible for this outcome analysis (because they had an spontaneous breathing trial attempt.
re-intubation
Outcome measures
| Measure |
Acute: REDvent
n=109 Participants
Acute Phase: The acute phase is defined as the time from intubation until the patient meets weaning criteria, passes the initial oxygenation test (decrease PEEP to 5 cmH2O and FiO2 to 0.5, maintains SpO2 \> 90%), and undergoes a Spontaneous Breathing Trial (SBT). Patients will be managed with pressure control plus pressure support ventilation using a computerized decision support tool that will recommend changes to ventilator settings approximately every 4 hr (with or without a new blood gas). If the patient is spontaneously breathing, it will incorporate real-time measures of effort of breathing (esophageal manometry) to keep it in a target range.
Computerized Ventilator Protocol: Computerized Decision Support System which recommends changes to ventilator settings to promote physiologic levels of patient effort of breathing.
Esophageal Manometry: Esophageal Manometry Catheter to measure effort of breathing an transpulmonary pressure
Respiratory Inductance Plethysmography (RIP): RIP bands to measure thoraco-abdominal synchrony during spontaneous breathing trials
Diaphragm Ultrasound: Daily measurement of diaphragm thickness and diaphragm contractile activity
Maximal Inspiratory Pressure: Prior to Spontaneous breathing trials, measurement of airway and esophageal maximal inspiratory pressure during airway occlusion
|
Acute: Control
n=106 Participants
Acute Phase: The acute phase is defined as the time from intubation until the patient meets weaning criteria, passes the initial oxygenation test (decrease PEEP to 5 cmH2O and FiO2 to 0.5, maintains SpO2 \> 90%), and undergoes a Spontaneous Breathing Trial (SBT). Ventilator management will be per usual care until the patient meets weaning criteria and passes the oxygenation test.
Esophageal Manometry: Esophageal Manometry Catheter to measure effort of breathing an transpulmonary pressure
Respiratory Inductance Plethysmography (RIP): RIP bands to measure thoraco-abdominal synchrony during spontaneous breathing trials
Diaphragm Ultrasound: Daily measurement of diaphragm thickness and diaphragm contractile activity
Maximal Inspiratory Pressure: Prior to Spontaneous breathing trials, measurement of airway and esophageal maximal inspiratory pressure during airway occlusion
|
|---|---|---|
|
Number of Participants With Extubation Failure
|
8 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: Through study completion up to maximum of 90 DaysDeath
Outcome measures
| Measure |
Acute: REDvent
n=125 Participants
Acute Phase: The acute phase is defined as the time from intubation until the patient meets weaning criteria, passes the initial oxygenation test (decrease PEEP to 5 cmH2O and FiO2 to 0.5, maintains SpO2 \> 90%), and undergoes a Spontaneous Breathing Trial (SBT). Patients will be managed with pressure control plus pressure support ventilation using a computerized decision support tool that will recommend changes to ventilator settings approximately every 4 hr (with or without a new blood gas). If the patient is spontaneously breathing, it will incorporate real-time measures of effort of breathing (esophageal manometry) to keep it in a target range.
Computerized Ventilator Protocol: Computerized Decision Support System which recommends changes to ventilator settings to promote physiologic levels of patient effort of breathing.
Esophageal Manometry: Esophageal Manometry Catheter to measure effort of breathing an transpulmonary pressure
Respiratory Inductance Plethysmography (RIP): RIP bands to measure thoraco-abdominal synchrony during spontaneous breathing trials
Diaphragm Ultrasound: Daily measurement of diaphragm thickness and diaphragm contractile activity
Maximal Inspiratory Pressure: Prior to Spontaneous breathing trials, measurement of airway and esophageal maximal inspiratory pressure during airway occlusion
|
Acute: Control
n=122 Participants
Acute Phase: The acute phase is defined as the time from intubation until the patient meets weaning criteria, passes the initial oxygenation test (decrease PEEP to 5 cmH2O and FiO2 to 0.5, maintains SpO2 \> 90%), and undergoes a Spontaneous Breathing Trial (SBT). Ventilator management will be per usual care until the patient meets weaning criteria and passes the oxygenation test.
Esophageal Manometry: Esophageal Manometry Catheter to measure effort of breathing an transpulmonary pressure
Respiratory Inductance Plethysmography (RIP): RIP bands to measure thoraco-abdominal synchrony during spontaneous breathing trials
Diaphragm Ultrasound: Daily measurement of diaphragm thickness and diaphragm contractile activity
Maximal Inspiratory Pressure: Prior to Spontaneous breathing trials, measurement of airway and esophageal maximal inspiratory pressure during airway occlusion
|
|---|---|---|
|
Number of Participants With Mortality
|
21 Participants
|
18 Participants
|
SECONDARY outcome
Timeframe: Assessed on the day of first spontaneous breathing trial up to 28 daysMeasured during standardized airway occlusion maneuvers
Outcome measures
| Measure |
Acute: REDvent
n=110 Participants
Acute Phase: The acute phase is defined as the time from intubation until the patient meets weaning criteria, passes the initial oxygenation test (decrease PEEP to 5 cmH2O and FiO2 to 0.5, maintains SpO2 \> 90%), and undergoes a Spontaneous Breathing Trial (SBT). Patients will be managed with pressure control plus pressure support ventilation using a computerized decision support tool that will recommend changes to ventilator settings approximately every 4 hr (with or without a new blood gas). If the patient is spontaneously breathing, it will incorporate real-time measures of effort of breathing (esophageal manometry) to keep it in a target range.
Computerized Ventilator Protocol: Computerized Decision Support System which recommends changes to ventilator settings to promote physiologic levels of patient effort of breathing.
Esophageal Manometry: Esophageal Manometry Catheter to measure effort of breathing an transpulmonary pressure
Respiratory Inductance Plethysmography (RIP): RIP bands to measure thoraco-abdominal synchrony during spontaneous breathing trials
Diaphragm Ultrasound: Daily measurement of diaphragm thickness and diaphragm contractile activity
Maximal Inspiratory Pressure: Prior to Spontaneous breathing trials, measurement of airway and esophageal maximal inspiratory pressure during airway occlusion
|
Acute: Control
n=107 Participants
Acute Phase: The acute phase is defined as the time from intubation until the patient meets weaning criteria, passes the initial oxygenation test (decrease PEEP to 5 cmH2O and FiO2 to 0.5, maintains SpO2 \> 90%), and undergoes a Spontaneous Breathing Trial (SBT). Ventilator management will be per usual care until the patient meets weaning criteria and passes the oxygenation test.
Esophageal Manometry: Esophageal Manometry Catheter to measure effort of breathing an transpulmonary pressure
Respiratory Inductance Plethysmography (RIP): RIP bands to measure thoraco-abdominal synchrony during spontaneous breathing trials
Diaphragm Ultrasound: Daily measurement of diaphragm thickness and diaphragm contractile activity
Maximal Inspiratory Pressure: Prior to Spontaneous breathing trials, measurement of airway and esophageal maximal inspiratory pressure during airway occlusion
|
|---|---|---|
|
Median Maximal Inspiratory Airway Pressure During Airway Occlusion (aPiMax) at First Spontaneous Breathing Trial During Acute Phase.
|
51.3 centimeters of water
Interval 36.7 to 65.0
|
44.0 centimeters of water
Interval 34.0 to 60.0
|
SECONDARY outcome
Timeframe: Assessed on the day of first spontaneous breathing trial up to 28 daysMeasured during standardized airway occlusion maneuvers
Outcome measures
| Measure |
Acute: REDvent
n=104 Participants
Acute Phase: The acute phase is defined as the time from intubation until the patient meets weaning criteria, passes the initial oxygenation test (decrease PEEP to 5 cmH2O and FiO2 to 0.5, maintains SpO2 \> 90%), and undergoes a Spontaneous Breathing Trial (SBT). Patients will be managed with pressure control plus pressure support ventilation using a computerized decision support tool that will recommend changes to ventilator settings approximately every 4 hr (with or without a new blood gas). If the patient is spontaneously breathing, it will incorporate real-time measures of effort of breathing (esophageal manometry) to keep it in a target range.
Computerized Ventilator Protocol: Computerized Decision Support System which recommends changes to ventilator settings to promote physiologic levels of patient effort of breathing.
Esophageal Manometry: Esophageal Manometry Catheter to measure effort of breathing an transpulmonary pressure
Respiratory Inductance Plethysmography (RIP): RIP bands to measure thoraco-abdominal synchrony during spontaneous breathing trials
Diaphragm Ultrasound: Daily measurement of diaphragm thickness and diaphragm contractile activity
Maximal Inspiratory Pressure: Prior to Spontaneous breathing trials, measurement of airway and esophageal maximal inspiratory pressure during airway occlusion
|
Acute: Control
n=106 Participants
Acute Phase: The acute phase is defined as the time from intubation until the patient meets weaning criteria, passes the initial oxygenation test (decrease PEEP to 5 cmH2O and FiO2 to 0.5, maintains SpO2 \> 90%), and undergoes a Spontaneous Breathing Trial (SBT). Ventilator management will be per usual care until the patient meets weaning criteria and passes the oxygenation test.
Esophageal Manometry: Esophageal Manometry Catheter to measure effort of breathing an transpulmonary pressure
Respiratory Inductance Plethysmography (RIP): RIP bands to measure thoraco-abdominal synchrony during spontaneous breathing trials
Diaphragm Ultrasound: Daily measurement of diaphragm thickness and diaphragm contractile activity
Maximal Inspiratory Pressure: Prior to Spontaneous breathing trials, measurement of airway and esophageal maximal inspiratory pressure during airway occlusion
|
|---|---|---|
|
Median Maximal Inspiratory Esophageal Pressure During Airway Occlusion (ePiMax) During Acute Phase.
|
41.09 centimeters of water
Interval 27.5 to 52.17
|
35.5 centimeters of water
Interval 26.1 to 49.0
|
SECONDARY outcome
Timeframe: Each day from study initiation until extubation up to a maximum of 28 daysFrom daily ultrasound measurement
Outcome measures
| Measure |
Acute: REDvent
n=89 Participants
Acute Phase: The acute phase is defined as the time from intubation until the patient meets weaning criteria, passes the initial oxygenation test (decrease PEEP to 5 cmH2O and FiO2 to 0.5, maintains SpO2 \> 90%), and undergoes a Spontaneous Breathing Trial (SBT). Patients will be managed with pressure control plus pressure support ventilation using a computerized decision support tool that will recommend changes to ventilator settings approximately every 4 hr (with or without a new blood gas). If the patient is spontaneously breathing, it will incorporate real-time measures of effort of breathing (esophageal manometry) to keep it in a target range.
Computerized Ventilator Protocol: Computerized Decision Support System which recommends changes to ventilator settings to promote physiologic levels of patient effort of breathing.
Esophageal Manometry: Esophageal Manometry Catheter to measure effort of breathing an transpulmonary pressure
Respiratory Inductance Plethysmography (RIP): RIP bands to measure thoraco-abdominal synchrony during spontaneous breathing trials
Diaphragm Ultrasound: Daily measurement of diaphragm thickness and diaphragm contractile activity
Maximal Inspiratory Pressure: Prior to Spontaneous breathing trials, measurement of airway and esophageal maximal inspiratory pressure during airway occlusion
|
Acute: Control
n=83 Participants
Acute Phase: The acute phase is defined as the time from intubation until the patient meets weaning criteria, passes the initial oxygenation test (decrease PEEP to 5 cmH2O and FiO2 to 0.5, maintains SpO2 \> 90%), and undergoes a Spontaneous Breathing Trial (SBT). Ventilator management will be per usual care until the patient meets weaning criteria and passes the oxygenation test.
Esophageal Manometry: Esophageal Manometry Catheter to measure effort of breathing an transpulmonary pressure
Respiratory Inductance Plethysmography (RIP): RIP bands to measure thoraco-abdominal synchrony during spontaneous breathing trials
Diaphragm Ultrasound: Daily measurement of diaphragm thickness and diaphragm contractile activity
Maximal Inspiratory Pressure: Prior to Spontaneous breathing trials, measurement of airway and esophageal maximal inspiratory pressure during airway occlusion
|
|---|---|---|
|
Median Percentage Change in Diaphragm Thickness on Exhalation (Dte) From Baseline During Acute Phase
|
-2 Percentage
Interval -25.0 to 14.0
|
-1 Percentage
Interval -18.0 to 17.0
|
Adverse Events
Acute: REDvent
Serious events: 19 serious events
Other events: 18 other events
Deaths: 16 deaths
Acute: Control
Serious events: 17 serious events
Other events: 19 other events
Deaths: 14 deaths
Weaning: REDvent
Serious events: 0 serious events
Other events: 4 other events
Deaths: 4 deaths
Weaning: Control
Serious events: 0 serious events
Other events: 7 other events
Deaths: 5 deaths
Serious adverse events
| Measure |
Acute: REDvent
n=125 participants at risk
Acute Phase: The acute phase is defined as the time from intubation until the patient meets weaning criteria, passes the initial oxygenation test (decrease PEEP to 5 cmH2O and FiO2 to 0.5, maintains SpO2 \> 90%), and undergoes a Spontaneous Breathing Trial (SBT). Patients will be managed with pressure control plus pressure support ventilation using a computerized decision support tool that will recommend changes to ventilator settings approximately every 4 hr (with or without a new blood gas). If the patient is spontaneously breathing, it will incorporate real-time measures of effort of breathing (esophageal manometry) to keep it in a target range.
Computerized Ventilator Protocol: Computerized Decision Support System which recommends changes to ventilator settings to promote physiologic levels of patient effort of breathing.
Esophageal Manometry: Esophageal Manometry Catheter to measure effort of breathing an transpulmonary pressure
Respiratory Inductance Plethysmography (RIP): RIP bands to measure thoraco-abdominal synchrony during spontaneous breathing trials
Diaphragm Ultrasound: Daily measurement of diaphragm thickness and diaphragm contractile activity
Maximal Inspiratory Pressure: Prior to Spontaneous breathing trials, measurement of airway and esophageal maximal inspiratory pressure during airway occlusion
|
Acute: Control
n=122 participants at risk
Acute Phase: The acute phase is defined as the time from intubation until the patient meets weaning criteria, passes the initial oxygenation test (decrease PEEP to 5 cmH2O and FiO2 to 0.5, maintains SpO2 \> 90%), and undergoes a Spontaneous Breathing Trial (SBT). Ventilator management will be per usual care until the patient meets weaning criteria and passes the oxygenation test.
Esophageal Manometry: Esophageal Manometry Catheter to measure effort of breathing an transpulmonary pressure
Respiratory Inductance Plethysmography (RIP): RIP bands to measure thoraco-abdominal synchrony during spontaneous breathing trials
Diaphragm Ultrasound: Daily measurement of diaphragm thickness and diaphragm contractile activity
Maximal Inspiratory Pressure: Prior to Spontaneous breathing trials, measurement of airway and esophageal maximal inspiratory pressure during airway occlusion
|
Weaning: REDvent
n=58 participants at risk
The weaning phase is defined as the time from the first SBT until the patient successfully passes an SBT. SBTs are performed daily during the weaning phase, along with measurement of PiMax with airway occlusion maneuvers. Patients will be managed in a PS/CPAP mode of ventilation and PRP will be monitored continuously, adjusting PS (to a max of 20 cmH20) every 4 h to maintain PRP in the target range. PEEP may be adjusted between 5 and 10 cmH20. Weaning phase intervention continues until extubation.
|
Weaning: Control
n=58 participants at risk
The weaning phase is defined as the time from the first SBT until the patient successfully passes an SBT. SBTs are performed daily during the weaning phase, along with measurement of PiMax with airway occlusion maneuvers. Ventilator management will be per usual care as determined by the treating clinical team until the patient is extubated.
|
|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Sustained hypoxemia
|
2.4%
3/125 • Number of events 3 • 90 days
|
1.6%
2/122 • Number of events 2 • 90 days
|
0.00%
0/58 • 90 days
|
0.00%
0/58 • 90 days
|
|
Respiratory, thoracic and mediastinal disorders
Air leak
|
4.8%
6/125 • Number of events 6 • 90 days
|
2.5%
3/122 • Number of events 3 • 90 days
|
0.00%
0/58 • 90 days
|
0.00%
0/58 • 90 days
|
|
Injury, poisoning and procedural complications
Unplanned Extubation
|
0.00%
0/125 • 90 days
|
0.82%
1/122 • Number of events 1 • 90 days
|
0.00%
0/58 • 90 days
|
0.00%
0/58 • 90 days
|
|
Cardiac disorders
Arrythmia
|
0.80%
1/125 • Number of events 1 • 90 days
|
0.00%
0/122 • 90 days
|
0.00%
0/58 • 90 days
|
0.00%
0/58 • 90 days
|
|
Cardiac disorders
Bradycardia
|
0.80%
1/125 • Number of events 1 • 90 days
|
0.00%
0/122 • 90 days
|
0.00%
0/58 • 90 days
|
0.00%
0/58 • 90 days
|
|
General disorders
Intracranial event/hemorrhage
|
1.6%
2/125 • Number of events 2 • 90 days
|
0.82%
1/122 • Number of events 1 • 90 days
|
0.00%
0/58 • 90 days
|
0.00%
0/58 • 90 days
|
|
Cardiac disorders
Cardiac Arrest/ECMO
|
0.80%
1/125 • Number of events 1 • 90 days
|
3.3%
4/122 • Number of events 4 • 90 days
|
0.00%
0/58 • 90 days
|
0.00%
0/58 • 90 days
|
|
Respiratory, thoracic and mediastinal disorders
Diffuse alveolar hemorrhage
|
0.80%
1/125 • Number of events 1 • 90 days
|
0.00%
0/122 • 90 days
|
0.00%
0/58 • 90 days
|
0.00%
0/58 • 90 days
|
|
General disorders
Progressive multi-organ failure
|
3.2%
4/125 • Number of events 4 • 90 days
|
4.9%
6/122 • Number of events 6 • 90 days
|
0.00%
0/58 • 90 days
|
0.00%
0/58 • 90 days
|
|
General disorders
Progression of underlying neurologic disease
|
0.80%
1/125 • Number of events 1 • 90 days
|
0.00%
0/122 • 90 days
|
0.00%
0/58 • 90 days
|
0.00%
0/58 • 90 days
|
|
General disorders
Refractory shock
|
0.00%
0/125 • 90 days
|
0.82%
1/122 • Number of events 1 • 90 days
|
0.00%
0/58 • 90 days
|
0.00%
0/58 • 90 days
|
|
General disorders
Refractory brain tumor and hypoxemia
|
0.80%
1/125 • Number of events 1 • 90 days
|
0.00%
0/122 • 90 days
|
0.00%
0/58 • 90 days
|
0.00%
0/58 • 90 days
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.00%
0/125 • 90 days
|
0.82%
1/122 • Number of events 1 • 90 days
|
0.00%
0/58 • 90 days
|
0.00%
0/58 • 90 days
|
Other adverse events
| Measure |
Acute: REDvent
n=125 participants at risk
Acute Phase: The acute phase is defined as the time from intubation until the patient meets weaning criteria, passes the initial oxygenation test (decrease PEEP to 5 cmH2O and FiO2 to 0.5, maintains SpO2 \> 90%), and undergoes a Spontaneous Breathing Trial (SBT). Patients will be managed with pressure control plus pressure support ventilation using a computerized decision support tool that will recommend changes to ventilator settings approximately every 4 hr (with or without a new blood gas). If the patient is spontaneously breathing, it will incorporate real-time measures of effort of breathing (esophageal manometry) to keep it in a target range.
Computerized Ventilator Protocol: Computerized Decision Support System which recommends changes to ventilator settings to promote physiologic levels of patient effort of breathing.
Esophageal Manometry: Esophageal Manometry Catheter to measure effort of breathing an transpulmonary pressure
Respiratory Inductance Plethysmography (RIP): RIP bands to measure thoraco-abdominal synchrony during spontaneous breathing trials
Diaphragm Ultrasound: Daily measurement of diaphragm thickness and diaphragm contractile activity
Maximal Inspiratory Pressure: Prior to Spontaneous breathing trials, measurement of airway and esophageal maximal inspiratory pressure during airway occlusion
|
Acute: Control
n=122 participants at risk
Acute Phase: The acute phase is defined as the time from intubation until the patient meets weaning criteria, passes the initial oxygenation test (decrease PEEP to 5 cmH2O and FiO2 to 0.5, maintains SpO2 \> 90%), and undergoes a Spontaneous Breathing Trial (SBT). Ventilator management will be per usual care until the patient meets weaning criteria and passes the oxygenation test.
Esophageal Manometry: Esophageal Manometry Catheter to measure effort of breathing an transpulmonary pressure
Respiratory Inductance Plethysmography (RIP): RIP bands to measure thoraco-abdominal synchrony during spontaneous breathing trials
Diaphragm Ultrasound: Daily measurement of diaphragm thickness and diaphragm contractile activity
Maximal Inspiratory Pressure: Prior to Spontaneous breathing trials, measurement of airway and esophageal maximal inspiratory pressure during airway occlusion
|
Weaning: REDvent
n=58 participants at risk
The weaning phase is defined as the time from the first SBT until the patient successfully passes an SBT. SBTs are performed daily during the weaning phase, along with measurement of PiMax with airway occlusion maneuvers. Patients will be managed in a PS/CPAP mode of ventilation and PRP will be monitored continuously, adjusting PS (to a max of 20 cmH20) every 4 h to maintain PRP in the target range. PEEP may be adjusted between 5 and 10 cmH20. Weaning phase intervention continues until extubation.
|
Weaning: Control
n=58 participants at risk
The weaning phase is defined as the time from the first SBT until the patient successfully passes an SBT. SBTs are performed daily during the weaning phase, along with measurement of PiMax with airway occlusion maneuvers. Ventilator management will be per usual care as determined by the treating clinical team until the patient is extubated.
|
|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Air leak
|
0.80%
1/125 • Number of events 1 • 90 days
|
0.00%
0/122 • 90 days
|
0.00%
0/58 • 90 days
|
0.00%
0/58 • 90 days
|
|
Injury, poisoning and procedural complications
Esphageal catheter in trachea-bronchial tree
|
2.4%
3/125 • Number of events 3 • 90 days
|
0.00%
0/122 • 90 days
|
0.00%
0/58 • 90 days
|
0.00%
0/58 • 90 days
|
|
Respiratory, thoracic and mediastinal disorders
Failure of weaning phase
|
—
0/0 • 90 days
|
—
0/0 • 90 days
|
5.2%
3/58 • Number of events 3 • 90 days
|
0.00%
0/58 • 90 days
|
|
Respiratory, thoracic and mediastinal disorders
Re-intubation
|
0.80%
1/125 • Number of events 1 • 90 days
|
0.00%
0/122 • 90 days
|
1.7%
1/58 • Number of events 1 • 90 days
|
1.7%
1/58 • Number of events 1 • 90 days
|
|
Respiratory, thoracic and mediastinal disorders
Sustained hypoxemia
|
9.6%
12/125 • Number of events 30 • 90 days
|
12.3%
15/122 • Number of events 76 • 90 days
|
0.00%
0/58 • 90 days
|
8.6%
5/58 • Number of events 6 • 90 days
|
|
Injury, poisoning and procedural complications
Unplanned Extubation
|
1.6%
2/125 • Number of events 2 • 90 days
|
0.00%
0/122 • 90 days
|
1.7%
1/58 • Number of events 1 • 90 days
|
0.00%
0/58 • 90 days
|
|
Injury, poisoning and procedural complications
Esophageal catheter complication
|
0.00%
0/125 • 90 days
|
2.5%
3/122 • Number of events 3 • 90 days
|
0.00%
0/58 • 90 days
|
1.7%
1/58 • Number of events 1 • 90 days
|
|
Cardiac disorders
Arrythmia
|
0.80%
1/125 • Number of events 1 • 90 days
|
0.00%
0/122 • 90 days
|
0.00%
0/58 • 90 days
|
0.00%
0/58 • 90 days
|
|
Cardiac disorders
Bradycardia
|
0.80%
1/125 • Number of events 2 • 90 days
|
1.6%
2/122 • Number of events 2 • 90 days
|
0.00%
0/58 • 90 days
|
0.00%
0/58 • 90 days
|
|
Cardiac disorders
Supra ventricular tachycardia
|
0.80%
1/125 • Number of events 1 • 90 days
|
0.00%
0/122 • 90 days
|
0.00%
0/58 • 90 days
|
0.00%
0/58 • 90 days
|
Additional Information
Dr. Robinder Khemani, MD. Medical Staff/USC Faculty
Children's Hospital Los Angeles
Phone: 3233612376
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place