Trial Outcomes & Findings for NAVA vs. CMV Crossover in Severe BPD (NCT NCT04821453)
NCT ID: NCT04821453
Last Updated: 2026-05-20
Results Overview
The Oxygenation Saturation Index (OSI) is a composite measure of the severity of hypoxic respiratory failure. It quantifies how much ventilatory support is required to achieve a given level of oxygen saturation. Lower OSI values indicate better oxygenation and better clinical status. Higher OSI values indicate worse oxygenation and more severe respiratory failure. Oxygen saturation index will be measured by assessing if invasive mechanical ventilation with NAVA compared to CMV improves respiratory gas exchange in patients receiving invasive respiratory support for BPD. This will be calculated as the mean, time-weighted daily oxygen saturation (SpO2) index (\[mean airway pressure x Fraction of inspired oxygen (FiO2)\]/SpO2).
TERMINATED
NA
12 participants
up to 5 days per study arm
2026-05-20
Participant Flow
12 subjects were enrolled in the study and 9 completed the study.
Participant milestones
| Measure |
Neurally Adjusted Ventilatory Assist (NAVA) Followed by CMV
Subjects will be ventilated on neurally adjusted ventilatory assist (NAVA) mode with data collected for the first 5 day time, followed by a second day time frame in which subjects will be ventilated with conventional mechanical ventilation (CMV). Data will be collected throughout the two 5 day periods for comaprison.
NAVA: NAVA mode of mechanical ventilation provide the trigger for a spontaneous breath from the diaphragmatic movement instead of diaphragm and allows the patient to control the dynamics of the breath generally set in CMV mode.
CMV: CMV mode of mechanical ventilation that provides a trigger for a spontaneous breath from the airway flow sensor with dynamics of the breath set as required by the mode
|
Conventional Flow Triggered Mechanical Ventilation (CMV) Followed by NAVA
Subjects will be ventilated with Conventional Mechanical Ventilation (CMV) with for the first 5 day time frame, followed by a second 5 day time frame in which subjects will be ventilated with Neurally Adjusted Ventilatory Assist (NAVA) mode. Data will be collected throughout both 5 day time frames for comparison.
CMV: CMV mode of mechanical ventilation that provides a trigger for a spontaneous breath from the airway flow sensor with dynamics of the breath set as required by the mode
NAVA: NAVA mode of mechanical ventilation provide the trigger for a spontaneous breath from the diaphragmatic movement instead of diaphragm and allows the patient to control the dynamics of the breath generally set in CMV mode.
|
|---|---|---|
|
Mechanical Ventilation Sequence 1
STARTED
|
7
|
5
|
|
Mechanical Ventilation Sequence 1
COMPLETED
|
5
|
5
|
|
Mechanical Ventilation Sequence 1
NOT COMPLETED
|
2
|
0
|
|
Mechanical Ventilation Sequence 2
STARTED
|
5
|
5
|
|
Mechanical Ventilation Sequence 2
COMPLETED
|
5
|
4
|
|
Mechanical Ventilation Sequence 2
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Neurally Adjusted Ventilatory Assist (NAVA) Followed by CMV
Subjects will be ventilated on neurally adjusted ventilatory assist (NAVA) mode with data collected for the first 5 day time, followed by a second day time frame in which subjects will be ventilated with conventional mechanical ventilation (CMV). Data will be collected throughout the two 5 day periods for comaprison.
NAVA: NAVA mode of mechanical ventilation provide the trigger for a spontaneous breath from the diaphragmatic movement instead of diaphragm and allows the patient to control the dynamics of the breath generally set in CMV mode.
CMV: CMV mode of mechanical ventilation that provides a trigger for a spontaneous breath from the airway flow sensor with dynamics of the breath set as required by the mode
|
Conventional Flow Triggered Mechanical Ventilation (CMV) Followed by NAVA
Subjects will be ventilated with Conventional Mechanical Ventilation (CMV) with for the first 5 day time frame, followed by a second 5 day time frame in which subjects will be ventilated with Neurally Adjusted Ventilatory Assist (NAVA) mode. Data will be collected throughout both 5 day time frames for comparison.
CMV: CMV mode of mechanical ventilation that provides a trigger for a spontaneous breath from the airway flow sensor with dynamics of the breath set as required by the mode
NAVA: NAVA mode of mechanical ventilation provide the trigger for a spontaneous breath from the diaphragmatic movement instead of diaphragm and allows the patient to control the dynamics of the breath generally set in CMV mode.
|
|---|---|---|
|
Mechanical Ventilation Sequence 1
Unable to complete due to change in patient status.
|
1
|
0
|
|
Mechanical Ventilation Sequence 1
Patient transferred
|
1
|
0
|
|
Mechanical Ventilation Sequence 2
Adverse Event
|
0
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
All Study Participants
n=12 Participants
All study participants include Conventional Flow Triggered Mechanical Ventilation (CMV) and Neurally Adjusted Ventilatory Assist (NAVA)
CMV: CMV mode of mechanical ventilation that provides a trigger for a spontaneous breath from the airway flow sensor with dynamics of the breath set as required by the mode
NAVA: NAVA mode of mechanical ventilation provide the trigger for a spontaneous breath from the diaphragmatic movement instead of diaphragm and allows the patient to control the dynamics of the breath generally set in CMV mode.
|
|---|---|
|
Age, Customized
Under 13 months of age
|
12 Participants
n=12 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=12 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=12 Participants
|
|
Gestational Age at Birth
23-25 weeks
|
6 Count of Participants
n=12 Participants
|
|
Gestational Age at Birth
26-29 weeks
|
6 Count of Participants
n=12 Participants
|
|
Birth Weight
300-1000 g
|
11 Count of Participants
n=12 Participants
|
|
Birth Weight
>1000 g
|
1 Count of Participants
n=12 Participants
|
PRIMARY outcome
Timeframe: up to 5 days per study armPopulation: Three were withdrawn early during the NAVA arm. 2 due to concern for increased hypoxemic episodes and 1 was removed for ventilator technical fault unrelated to patient safety. There is partial data for the 3 subjects who were withdrawn early from the NAVA arm. 1 was never able to be successfully placed on NAVA mode for disordered breathing.
The Oxygenation Saturation Index (OSI) is a composite measure of the severity of hypoxic respiratory failure. It quantifies how much ventilatory support is required to achieve a given level of oxygen saturation. Lower OSI values indicate better oxygenation and better clinical status. Higher OSI values indicate worse oxygenation and more severe respiratory failure. Oxygen saturation index will be measured by assessing if invasive mechanical ventilation with NAVA compared to CMV improves respiratory gas exchange in patients receiving invasive respiratory support for BPD. This will be calculated as the mean, time-weighted daily oxygen saturation (SpO2) index (\[mean airway pressure x Fraction of inspired oxygen (FiO2)\]/SpO2).
Outcome measures
| Measure |
Conventional Mechanical Ventilation (CMV)
n=10 Participants
Subjects will be ventilated with Conventional Mechanical Ventilation (CMV) with data collected for the first 5 day time frame, followed by a second 5 day time frame to compare to the experimental arm.
CMV: CMV mode of mechanical ventilation that provides a trigger for a spontaneous breath from the airway flow sensor with dynamics of the breath set as required by the mode
|
Neurally Adjusted Ventilatory Assist (NAVA)
n=9 Participants
Subjects will be ventilated on neurally adjusted ventilatory assist (NAVA) mode with data collected for the first 5 day time frame, followed by a second 5 day time frame to compare to the experimental arm.
NAVA: NAVA mode of mechanical ventilation provide the trigger for a spontaneous breath from the diaphragmatic movement instead of diaphragm and allows the patient to control the dynamics of the breath generally set in CMV mode.
|
|---|---|---|
|
Oxygen Saturation (SpO2) Index
|
7.7 Oxygen Saturation Index (OSI)
Standard Deviation 4.7
|
7.7 Oxygen Saturation Index (OSI)
Standard Deviation 4.8
|
SECONDARY outcome
Timeframe: up to 5 days per study armPopulation: Three were withdrawn early during the NAVA arm. 2 due to concern for increased hypoxemic episodes and 1 was removed for ventilator technical fault unrelated to patient safety. There is partial data for the 3 subjects who were withdrawn early from the NAVA arm. 1 was never able to be successfully placed on NAVA mode for disordered breathing.
The need for sedation medication will be assessed by comparing the needs for sedation by the average daily dose milligram/kilogram (mg/kg) of sedation medications on invasive mechanical ventilation with NAVA compared to CMV.
Outcome measures
| Measure |
Conventional Mechanical Ventilation (CMV)
n=10 Participants
Subjects will be ventilated with Conventional Mechanical Ventilation (CMV) with data collected for the first 5 day time frame, followed by a second 5 day time frame to compare to the experimental arm.
CMV: CMV mode of mechanical ventilation that provides a trigger for a spontaneous breath from the airway flow sensor with dynamics of the breath set as required by the mode
|
Neurally Adjusted Ventilatory Assist (NAVA)
n=9 Participants
Subjects will be ventilated on neurally adjusted ventilatory assist (NAVA) mode with data collected for the first 5 day time frame, followed by a second 5 day time frame to compare to the experimental arm.
NAVA: NAVA mode of mechanical ventilation provide the trigger for a spontaneous breath from the diaphragmatic movement instead of diaphragm and allows the patient to control the dynamics of the breath generally set in CMV mode.
|
|---|---|---|
|
Sedation Medications
Opiates
|
1.30 mg/kg/day
Standard Deviation 1.23
|
1.57 mg/kg/day
Standard Deviation 1.33
|
|
Sedation Medications
Benzodiazepines
|
1.34 mg/kg/day
Standard Deviation 1.48
|
1.36 mg/kg/day
Standard Deviation 1.39
|
SECONDARY outcome
Timeframe: up to 5 days per study armPopulation: Three were withdrawn early during the NAVA arm. 2 due to concern for increased hypoxemic episodes and 1 was removed for ventilator technical fault unrelated to patient safety. There is partial data for the 3 subjects who were withdrawn early from the NAVA arm. 1 was never able to be successfully placed on NAVA mode for disordered breathing.
Patient stress will be assessed by collecting salivary swabs three times per day to measure cortisol levels. The daily cortisol levels will be averaged during each arm of the study. The averaged cortisol level per arm will be assessed and compared as a marker for patient stress on invasive mechanical ventilation with NAVA compared to CMV. Elevated salivary cortisol reflects greater stress response, whereas lower levels reflect reduced physiologic stress.
Outcome measures
| Measure |
Conventional Mechanical Ventilation (CMV)
n=10 Participants
Subjects will be ventilated with Conventional Mechanical Ventilation (CMV) with data collected for the first 5 day time frame, followed by a second 5 day time frame to compare to the experimental arm.
CMV: CMV mode of mechanical ventilation that provides a trigger for a spontaneous breath from the airway flow sensor with dynamics of the breath set as required by the mode
|
Neurally Adjusted Ventilatory Assist (NAVA)
n=9 Participants
Subjects will be ventilated on neurally adjusted ventilatory assist (NAVA) mode with data collected for the first 5 day time frame, followed by a second 5 day time frame to compare to the experimental arm.
NAVA: NAVA mode of mechanical ventilation provide the trigger for a spontaneous breath from the diaphragmatic movement instead of diaphragm and allows the patient to control the dynamics of the breath generally set in CMV mode.
|
|---|---|---|
|
Stress
|
0.30 μg/dL
Interval 0.16 to 0.54
|
0.38 μg/dL
Interval 0.2 to 0.89
|
Adverse Events
Conventional Flow Triggered Mechanical Ventilation (CMV)
Neurally Adjusted Ventilatory Assist (NAVA)
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Conventional Flow Triggered Mechanical Ventilation (CMV)
n=12 participants at risk
Subjects will be ventilated with conventional mechanical ventilation with data collected for the 5 day time frame to compare to the experimental arm
CMV: CMV mode of mechanical ventilation that provides a trigger for a spontaneous breath from the airway flow sensor with dynamics of the breath set as required by the mode
|
Neurally Adjusted Ventilatory Assist (NAVA)
n=12 participants at risk
Subjects will be ventilated on neurally adjusted ventilatory assist (NAVA) mode with data collected for the 5 day time frame to compare with placebo arm
NAVA: NAVA mode of mechanical ventilation provide the trigger for a spontaneous breath from the diaphragmatic movement instead of diaphragm and allows the patient to control the dynamics of the breath generally set in CMV mode.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Increased risk for Hypoxia
|
16.7%
2/12 • Number of events 3 • Up to 11 days
Due to the medical complexity of subjects, only intervention related AEs were captured.
|
33.3%
4/12 • Number of events 18 • Up to 11 days
Due to the medical complexity of subjects, only intervention related AEs were captured.
|
|
Injury, poisoning and procedural complications
Procedural Event
|
0.00%
0/12 • Up to 11 days
Due to the medical complexity of subjects, only intervention related AEs were captured.
|
8.3%
1/12 • Number of events 1 • Up to 11 days
Due to the medical complexity of subjects, only intervention related AEs were captured.
|
Additional Information
Natalie Napolitano, PhD, RRT-NPS, FAARC
The Children's Hospital of Philadelphia
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place