Trial Outcomes & Findings for Mode Of Ventilation During Critical IllnEss Pilot Trial (NCT NCT05563779)
NCT ID: NCT05563779
Last Updated: 2026-02-23
Results Overview
Number of days alive and free from invasive mechanical ventilation between the final liberation from invasive mechanical ventilation before 28 days and study day 28. Patients who continue to receive invasive mechanical ventilation at day 28 or have died prior to day 28 will receive zero VFDs. For patients who return to invasive mechanical ventilation and are subsequently liberated from invasive mechanical ventilation prior to day 28, VFDs will be counted from final liberation from mechanical ventilation.
COMPLETED
NA
566 participants
Enrollment to 28 days
2026-02-23
Participant Flow
During the 9 months of enrollment in the MODE trial, the entire medical ICU will be assigned to a single ventilator mode with the assigned mode alternating between volume control, pressure control, and adaptive pressure control modes every month in a randomly generated sequence. All patients who receive invasive mechanical ventilation and meet inclusion criteria without meeting exclusion criteria will be enrolled. The study mode will be assigned according to the month of enrollment.
Patients will be assigned to only the mode of ventilation at enrollment and analyzed according to the assigned mode. If patients continue to receive mechanical ventilation at the start of the next study block, choice of the ventilator mode will be at the discretion of clinicians. Patients will not crossover to another mode of ventilation. Participation ends at the first of hospital discharge or death.
Participant milestones
| Measure |
Volume Control Mode
During invasive mechanical ventilation in a study location, Volume Control will be used as the mode for continuous mandatory ventilation.
|
Pressure Control Mode
During invasive mechanical ventilation in a study location, Pressure Control will be used as the mode for continuous mandatory ventilation.
|
Adaptive Pressure Control Mode
During invasive mechanical ventilation in a study location, Adaptive Pressure Control will be used as the mode for continuous mandatory ventilation.
|
|---|---|---|---|
|
Overall Study
STARTED
|
181
|
198
|
187
|
|
Overall Study
COMPLETED
|
181
|
198
|
187
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Mode Of Ventilation During Critical IllnEss Pilot Trial
Baseline characteristics by cohort
| Measure |
Volume Control Mode
n=181 Participants
During invasive mechanical ventilation in a study location, Volume Control will be used as the mode for continuous mandatory ventilation.
|
Pressure Control Mode
n=198 Participants
During invasive mechanical ventilation in a study location, Pressure Control will be used as the mode for continuous mandatory ventilation.
|
Adaptive Pressure Control Mode
n=187 Participants
During invasive mechanical ventilation in a study location, Adaptive Pressure Control will be used as the mode for continuous mandatory ventilation.
|
Total
n=566 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
59.9 Years
n=58 Participants
|
56.9 Years
|
57.7 Years
n=1 Participants
|
57.0 Years
n=5 Participants
|
|
Sex: Female, Male
Female
|
82 Participants
n=58 Participants
|
81 Participants
|
71 Participants
n=1 Participants
|
234 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
99 Participants
n=58 Participants
|
117 Participants
|
116 Participants
n=1 Participants
|
332 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=58 Participants
|
1 Participants
|
3 Participants
n=1 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=58 Participants
|
2 Participants
|
3 Participants
n=1 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=58 Participants
|
0 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
31 Participants
n=58 Participants
|
28 Participants
|
35 Participants
n=1 Participants
|
94 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
138 Participants
n=58 Participants
|
153 Participants
|
133 Participants
n=1 Participants
|
424 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=58 Participants
|
0 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
8 Participants
n=58 Participants
|
14 Participants
|
13 Participants
n=1 Participants
|
35 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
7 Participants
n=58 Participants
|
11 Participants
|
8 Participants
n=1 Participants
|
26 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
169 Participants
n=58 Participants
|
176 Participants
|
169 Participants
n=1 Participants
|
514 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=58 Participants
|
11 Participants
|
10 Participants
n=1 Participants
|
26 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Enrollment to 28 daysNumber of days alive and free from invasive mechanical ventilation between the final liberation from invasive mechanical ventilation before 28 days and study day 28. Patients who continue to receive invasive mechanical ventilation at day 28 or have died prior to day 28 will receive zero VFDs. For patients who return to invasive mechanical ventilation and are subsequently liberated from invasive mechanical ventilation prior to day 28, VFDs will be counted from final liberation from mechanical ventilation.
Outcome measures
| Measure |
Volume Control Mode
n=181 Participants
During invasive mechanical ventilation in a study location, Volume Control will be used as the mode for continuous mandatory ventilation.
|
Pressure Control Mode
n=198 Participants
During invasive mechanical ventilation in a study location, Pressure Control will be used as the mode for continuous mandatory ventilation.
|
Adaptive Pressure Control Mode
n=187 Participants
During invasive mechanical ventilation in a study location, Adaptive Pressure Control will be used as the mode for continuous mandatory ventilation.
|
|---|---|---|---|
|
Ventilator-free Days (VFDs) to Day 28 After Enrollment
|
23 Ventilator-free days to day 28
Interval 0.0 to 26.0
|
22 Ventilator-free days to day 28
Interval 0.0 to 26.0
|
24 Ventilator-free days to day 28
Interval 0.0 to 26.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Enrollment to 72 hoursPopulation: Data not available for 3 patients: 1 in Volume Control group and 2 in Adaptive Pressure Control group.
Percentage of time in the assigned mode while receiving invasive mechanical ventilation in the study ICU between enrollment and 72 hours after enrollment.
Outcome measures
| Measure |
Volume Control Mode
n=180 Participants
During invasive mechanical ventilation in a study location, Volume Control will be used as the mode for continuous mandatory ventilation.
|
Pressure Control Mode
n=198 Participants
During invasive mechanical ventilation in a study location, Pressure Control will be used as the mode for continuous mandatory ventilation.
|
Adaptive Pressure Control Mode
n=185 Participants
During invasive mechanical ventilation in a study location, Adaptive Pressure Control will be used as the mode for continuous mandatory ventilation.
|
|---|---|---|---|
|
Exposure to Assigned Study Mode in First 3 Days (Feasibility Outcome)
|
87.5 Percentage of time
Interval 61.0 to 98.4
|
90.2 Percentage of time
Interval 56.6 to 98.9
|
93.8 Percentage of time
Interval 74.2 to 99.7
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Enrollment to 72 hoursPopulation: Sixteen patients did not have a recorded mandatory mode of ventilation during the study period from enrollment to death or extubation: 5 in Volume Control group, 4 in Pressure Control group, and 7 in Adaptive Pressure Control group.
Percentage of time in the assigned mode while receiving invasive mechanical ventilation in the study ICU with a mandatory mode between enrollment and 72 hours after enrollment (excluding time spent in spontaneous modes).
Outcome measures
| Measure |
Volume Control Mode
n=176 Participants
During invasive mechanical ventilation in a study location, Volume Control will be used as the mode for continuous mandatory ventilation.
|
Pressure Control Mode
n=194 Participants
During invasive mechanical ventilation in a study location, Pressure Control will be used as the mode for continuous mandatory ventilation.
|
Adaptive Pressure Control Mode
n=180 Participants
During invasive mechanical ventilation in a study location, Adaptive Pressure Control will be used as the mode for continuous mandatory ventilation.
|
|---|---|---|---|
|
Adherence to Study Mode in First 3 Days (Feasibility Outcome)
|
100.0 Percentage of time
Interval 100.0 to 100.0
|
100.0 Percentage of time
Interval 98.9 to 100.0
|
100.0 Percentage of time
Interval 100.0 to 100.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Enrollment to 28 daysPopulation: Nineteen patients did not have receipt of the assigned study mode recorded from enrollment to death or extubation: 7 in Volume Control group, 5 in Pressure Control group, and 7 in Adaptive Pressure Control group.
Outcome measures
| Measure |
Volume Control Mode
n=174 Participants
During invasive mechanical ventilation in a study location, Volume Control will be used as the mode for continuous mandatory ventilation.
|
Pressure Control Mode
n=193 Participants
During invasive mechanical ventilation in a study location, Pressure Control will be used as the mode for continuous mandatory ventilation.
|
Adaptive Pressure Control Mode
n=180 Participants
During invasive mechanical ventilation in a study location, Adaptive Pressure Control will be used as the mode for continuous mandatory ventilation.
|
|---|---|---|---|
|
Time From Enrollment to Initiation of Assigned Mode of Mechanical Ventilation (Feasibility Outcome)
|
5.2 Hours
Interval 1.7 to 16.6
|
5.2 Hours
Interval 1.4 to 17.1
|
4.6 Hours
Interval 0.8 to 15.1
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Enrollment to 28 daysOutcome measures
| Measure |
Volume Control Mode
n=181 Participants
During invasive mechanical ventilation in a study location, Volume Control will be used as the mode for continuous mandatory ventilation.
|
Pressure Control Mode
n=198 Participants
During invasive mechanical ventilation in a study location, Pressure Control will be used as the mode for continuous mandatory ventilation.
|
Adaptive Pressure Control Mode
n=187 Participants
During invasive mechanical ventilation in a study location, Adaptive Pressure Control will be used as the mode for continuous mandatory ventilation.
|
|---|---|---|---|
|
Number of Patients With a "Mode Modification Sheet" Completed by Treating Clinicians (Feasibility Outcome)
|
19 Participants
|
25 Participants
|
4 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Enrollment to the first of extubation, 28 days, or deathPopulation: No tidal volume data were available for one patient in the Adaptive Pressure Control group.
Outcome measures
| Measure |
Volume Control Mode
n=181 Participants
During invasive mechanical ventilation in a study location, Volume Control will be used as the mode for continuous mandatory ventilation.
|
Pressure Control Mode
n=198 Participants
During invasive mechanical ventilation in a study location, Pressure Control will be used as the mode for continuous mandatory ventilation.
|
Adaptive Pressure Control Mode
n=186 Participants
During invasive mechanical ventilation in a study location, Adaptive Pressure Control will be used as the mode for continuous mandatory ventilation.
|
|---|---|---|---|
|
Exhaled Tidal Volume (mL/kg Predicted Body Weight) (Exploratory Efficacy and Safety Outcome)
|
6.2 mL / kg of predicted body weight
Interval 5.9 to 7.1
|
6.4 mL / kg of predicted body weight
Interval 5.8 to 7.4
|
6.2 mL / kg of predicted body weight
Interval 5.9 to 6.9
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Enrollment to the first of extubation, 28 days, or deathPopulation: Tidal volume data were not available for one patient in the Adaptive Pressure Control group.
Percentage of exhaled tidal volume values above target range (\>8mL/kg predicted body weight), reported as a percentage.
Outcome measures
| Measure |
Volume Control Mode
n=181 Participants
During invasive mechanical ventilation in a study location, Volume Control will be used as the mode for continuous mandatory ventilation.
|
Pressure Control Mode
n=198 Participants
During invasive mechanical ventilation in a study location, Pressure Control will be used as the mode for continuous mandatory ventilation.
|
Adaptive Pressure Control Mode
n=186 Participants
During invasive mechanical ventilation in a study location, Adaptive Pressure Control will be used as the mode for continuous mandatory ventilation.
|
|---|---|---|---|
|
Percentage of Exhaled Tidal Volumes Above Target Range (Exploratory Efficacy and Safety Outcome)
|
0.0 Percentage of time
Interval 0.0 to 8.3
|
6.8 Percentage of time
Interval 0.0 to 31.4
|
3.6 Percentage of time
Interval 0.0 to 14.3
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Enrollment to the first of 28 days or deathHypoxemia during mechanical ventilation defined as an SpO2 \<85% for more than 5 minutes
Outcome measures
| Measure |
Volume Control Mode
n=181 Participants
During invasive mechanical ventilation in a study location, Volume Control will be used as the mode for continuous mandatory ventilation.
|
Pressure Control Mode
n=198 Participants
During invasive mechanical ventilation in a study location, Pressure Control will be used as the mode for continuous mandatory ventilation.
|
Adaptive Pressure Control Mode
n=187 Participants
During invasive mechanical ventilation in a study location, Adaptive Pressure Control will be used as the mode for continuous mandatory ventilation.
|
|---|---|---|---|
|
Hypoxemia During Mechanical Ventilation (Exploratory Safety and Efficacy Outcome)
|
21 Participants
|
20 Participants
|
14 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Enrollment to 28 daysSevere acidemia during mechanical ventilation: pH \< 7.1 on blood gas
Outcome measures
| Measure |
Volume Control Mode
n=181 Participants
During invasive mechanical ventilation in a study location, Volume Control will be used as the mode for continuous mandatory ventilation.
|
Pressure Control Mode
n=198 Participants
During invasive mechanical ventilation in a study location, Pressure Control will be used as the mode for continuous mandatory ventilation.
|
Adaptive Pressure Control Mode
n=187 Participants
During invasive mechanical ventilation in a study location, Adaptive Pressure Control will be used as the mode for continuous mandatory ventilation.
|
|---|---|---|---|
|
Severe Acidemia During Mechanical Ventilation (Exploratory Safety and Efficacy Outcome)
|
22 Participants
|
21 Participants
|
14 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Enrollment to 1 dayOutcome measures
| Measure |
Volume Control Mode
n=181 Participants
During invasive mechanical ventilation in a study location, Volume Control will be used as the mode for continuous mandatory ventilation.
|
Pressure Control Mode
n=198 Participants
During invasive mechanical ventilation in a study location, Pressure Control will be used as the mode for continuous mandatory ventilation.
|
Adaptive Pressure Control Mode
n=187 Participants
During invasive mechanical ventilation in a study location, Adaptive Pressure Control will be used as the mode for continuous mandatory ventilation.
|
|---|---|---|---|
|
Number of Blood Gas Laboratory Tests on the First Study Day (Exploratory Safety and Efficacy Outcome)
|
3 count of blood gas laboratory tests
Interval 1.0 to 5.0
|
2 count of blood gas laboratory tests
Interval 1.0 to 5.0
|
3 count of blood gas laboratory tests
Interval 1.0 to 5.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Enrollment to 28 daysOutcome measures
| Measure |
Volume Control Mode
n=181 Participants
During invasive mechanical ventilation in a study location, Volume Control will be used as the mode for continuous mandatory ventilation.
|
Pressure Control Mode
n=198 Participants
During invasive mechanical ventilation in a study location, Pressure Control will be used as the mode for continuous mandatory ventilation.
|
Adaptive Pressure Control Mode
n=187 Participants
During invasive mechanical ventilation in a study location, Adaptive Pressure Control will be used as the mode for continuous mandatory ventilation.
|
|---|---|---|---|
|
Pneumomediastinum or Pneumothorax During Mechanical Ventilation (Exploratory Efficacy and Safety Outcome)
|
4 Participants
|
6 Participants
|
1 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Enrollment to 1 dayPopulation: Insufficient data were available for four patients: 2 patients in the Volume Control group and 2 patients in the Pressure Control group.
The Sequential Organ Failure Assessment (SOFA) score is composed of scores from six organ systems, graded from 0 to 4 according to the degree of dysfunction or failure. Scores range from 0 (no evidence of organ dysfunction or failure) to 24 (evidence of severe organ dysfunction or failure). The mean of SOFA scores on study day 1 was calculated for each patient.
Outcome measures
| Measure |
Volume Control Mode
n=179 Participants
During invasive mechanical ventilation in a study location, Volume Control will be used as the mode for continuous mandatory ventilation.
|
Pressure Control Mode
n=196 Participants
During invasive mechanical ventilation in a study location, Pressure Control will be used as the mode for continuous mandatory ventilation.
|
Adaptive Pressure Control Mode
n=187 Participants
During invasive mechanical ventilation in a study location, Adaptive Pressure Control will be used as the mode for continuous mandatory ventilation.
|
|---|---|---|---|
|
SOFA Score on the First Study Day (Exploratory Safety and Efficacy Outcome)
|
11.0 SOFA Score
Interval 8.4 to 13.9
|
11.9 SOFA Score
Interval 8.5 to 14.0
|
11.0 SOFA Score
Interval 8.4 to 13.9
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Enrollment to 28 daysNumber of days alive and without delirium or coma before 28 days to study day 28
Outcome measures
| Measure |
Volume Control Mode
n=181 Participants
During invasive mechanical ventilation in a study location, Volume Control will be used as the mode for continuous mandatory ventilation.
|
Pressure Control Mode
n=198 Participants
During invasive mechanical ventilation in a study location, Pressure Control will be used as the mode for continuous mandatory ventilation.
|
Adaptive Pressure Control Mode
n=187 Participants
During invasive mechanical ventilation in a study location, Adaptive Pressure Control will be used as the mode for continuous mandatory ventilation.
|
|---|---|---|---|
|
Delirium and Coma Free Days to Day 28 (Exploratory Efficacy and Safety Outcome)
|
21 Delirium and coma-free days to day 28
Interval 0.0 to 26.0
|
18 Delirium and coma-free days to day 28
Interval 0.0 to 26.0
|
22 Delirium and coma-free days to day 28
Interval 0.0 to 26.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Enrollment to 28 daysNumber of days alive and free from intensive care unit admission after the final transfer out of the intensive care unit before 28 days to study day 28
Outcome measures
| Measure |
Volume Control Mode
n=181 Participants
During invasive mechanical ventilation in a study location, Volume Control will be used as the mode for continuous mandatory ventilation.
|
Pressure Control Mode
n=198 Participants
During invasive mechanical ventilation in a study location, Pressure Control will be used as the mode for continuous mandatory ventilation.
|
Adaptive Pressure Control Mode
n=187 Participants
During invasive mechanical ventilation in a study location, Adaptive Pressure Control will be used as the mode for continuous mandatory ventilation.
|
|---|---|---|---|
|
Intensive Care Unit-free Days to Study Day 28 (Exploratory Clinical Outcome)
|
21 ICU-free days to day 28
Interval 0.0 to 25.0
|
19 ICU-free days to day 28
Interval 0.0 to 25.0
|
21 ICU-free days to day 28
Interval 0.0 to 25.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Enrollment to 28 daysNumber of days alive and free from hospitalization after the final transfer out of the hospital before 28 days to study day 28
Outcome measures
| Measure |
Volume Control Mode
n=181 Participants
During invasive mechanical ventilation in a study location, Volume Control will be used as the mode for continuous mandatory ventilation.
|
Pressure Control Mode
n=198 Participants
During invasive mechanical ventilation in a study location, Pressure Control will be used as the mode for continuous mandatory ventilation.
|
Adaptive Pressure Control Mode
n=187 Participants
During invasive mechanical ventilation in a study location, Adaptive Pressure Control will be used as the mode for continuous mandatory ventilation.
|
|---|---|---|---|
|
Hospital-Free Days to Study Day 28 (Exploratory Clinical Outcome)
|
8 Hospital-free days to day 28
Interval 0.0 to 19.0
|
7 Hospital-free days to day 28
Interval 0.0 to 20.0
|
9 Hospital-free days to day 28
Interval 0.0 to 21.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Enrollment to 28 daysAll-cause mortality prior to discharge from the hospital, assessed at 28 days after enrollment
Outcome measures
| Measure |
Volume Control Mode
n=181 Participants
During invasive mechanical ventilation in a study location, Volume Control will be used as the mode for continuous mandatory ventilation.
|
Pressure Control Mode
n=198 Participants
During invasive mechanical ventilation in a study location, Pressure Control will be used as the mode for continuous mandatory ventilation.
|
Adaptive Pressure Control Mode
n=187 Participants
During invasive mechanical ventilation in a study location, Adaptive Pressure Control will be used as the mode for continuous mandatory ventilation.
|
|---|---|---|---|
|
In-hospital Mortality to Study Day 28 (Exploratory Clinical Outcome)
|
59 Participants
|
67 Participants
|
60 Participants
|
Adverse Events
Volume Control Mode
Pressure Control Mode
Adaptive Pressure Control Mode
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place