Trial Outcomes & Findings for NAVA Versus BiPAP Non-Invasive Respiratory Support in Infants Following Congenital Heart Surgery (NCT NCT03180385)
NCT ID: NCT03180385
Last Updated: 2020-03-10
Results Overview
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
15 participants
Primary outcome timeframe
Up to 14 days post-operatively
Results posted on
2020-03-10
Participant Flow
Informed consent was obtained for 15 participants. However, the reason there are only 2 participants listed under "total started in participant flow" is because these were the only participants who were actually randomized. The other 13 participants were extubated and did not need BiPAP/NAVA. They were not randomized and were excluded.
Participant milestones
| Measure |
Neurally-Adjusted Ventilatory Assist (NAVA)
Synchronized biphasic non-invasive respiratory support
Neurally-Adusted Ventilatory Assist (NAVA): Delivery of positive pressure is based on the electrical activity of the diaphragm (Edi) via a nasogastric (NG) catheter that is placed on the phrenic nerve, which runs along the esophagus. This results in synchronous ventilation for the patient.
|
Biphasic Positive Airway Pressure Support (BiPAP)
Conventional non-invasive respiratory support
Biphasic Positive Airway Pressure Support (BiPAP): Conventional form of non-invasive respiratory support that does not deliver positive airway pressure in a synchronous fashion.
|
|---|---|---|
|
Overall Study
STARTED
|
0
|
2
|
|
Overall Study
COMPLETED
|
0
|
2
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Neurally-Adjusted Ventilatory Assist (NAVA)
Synchronized biphasic non-invasive respiratory support
Neurally-Adusted Ventilatory Assist (NAVA): Delivery of positive pressure is based on the electrical activity of the diaphragm (Edi) via a nasogastric (NG) catheter that is placed on the phrenic nerve, which runs along the esophagus. This results in synchronous ventilation for the patient.
|
Biphasic Positive Airway Pressure Support (BiPAP)
n=2 Participants
Conventional non-invasive respiratory support
Biphasic Positive Airway Pressure Support (BiPAP): Conventional form of non-invasive respiratory support that does not deliver positive airway pressure in a synchronous fashion.
|
Total
n=2 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
—
|
0.46 years
STANDARD_DEVIATION 0.04 • n=2 Participants
|
0.46 years
STANDARD_DEVIATION 0.04 • n=2 Participants
|
|
Sex: Female, Male
Female
|
—
|
1 Participants
n=2 Participants
|
1 Participants
n=2 Participants
|
|
Sex: Female, Male
Male
|
—
|
1 Participants
n=2 Participants
|
1 Participants
n=2 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
—
|
2 participants
n=2 Participants
|
2 participants
n=2 Participants
|
PRIMARY outcome
Timeframe: Up to 14 days post-operativelyPopulation: All patients who were randomized ended up in the BiPAP group and not the NAVA group.
Outcome measures
| Measure |
Neurally-Adjusted Ventilatory Assist (NAVA)
Synchronized biphasic non-invasive respiratory support
Neurally-Adusted Ventilatory Assist (NAVA): Delivery of positive pressure is based on the electrical activity of the diaphragm (Edi) via a nasogastric (NG) catheter that is placed on the phrenic nerve, which runs along the esophagus. This results in synchronous ventilation for the patient.
|
Biphasic Positive Airway Pressure Support (BiPAP)
n=2 Participants
Conventional non-invasive respiratory support
Biphasic Positive Airway Pressure Support (BiPAP): Conventional form of non-invasive respiratory support that does not deliver positive airway pressure in a synchronous fashion.
|
|---|---|---|
|
Average Post-operative Midazolam Dose
|
—
|
0.035 mg/kg
Standard Deviation 0.007
|
PRIMARY outcome
Timeframe: Up to 14 days post-operativelyPopulation: There were no FLACC scores in the electronic medical record for either of these 2 participants so this is why there are no results reported.
FLACC (Face, Legs, Activity, Cry, Consolability) scale
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Up to 14 days post-operativelyPopulation: There were no SBS scores in the electronic medical record for either of these 2 participants so this is why results were not reported.
SBS (State Behavioral Scale)
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Up to 14 days post-operativelyPopulation: All patients who were randomized ended up in the BiPAP group and not the NAVA group.
Outcome measures
| Measure |
Neurally-Adjusted Ventilatory Assist (NAVA)
Synchronized biphasic non-invasive respiratory support
Neurally-Adusted Ventilatory Assist (NAVA): Delivery of positive pressure is based on the electrical activity of the diaphragm (Edi) via a nasogastric (NG) catheter that is placed on the phrenic nerve, which runs along the esophagus. This results in synchronous ventilation for the patient.
|
Biphasic Positive Airway Pressure Support (BiPAP)
n=2 Participants
Conventional non-invasive respiratory support
Biphasic Positive Airway Pressure Support (BiPAP): Conventional form of non-invasive respiratory support that does not deliver positive airway pressure in a synchronous fashion.
|
|---|---|---|
|
Length of Intubation
|
—
|
37.24 hours
Standard Deviation 3.87
|
PRIMARY outcome
Timeframe: Up to 14 days post-operativelyPopulation: For this outcome, data for only one participant is available
Outcome measures
| Measure |
Neurally-Adjusted Ventilatory Assist (NAVA)
Synchronized biphasic non-invasive respiratory support
Neurally-Adusted Ventilatory Assist (NAVA): Delivery of positive pressure is based on the electrical activity of the diaphragm (Edi) via a nasogastric (NG) catheter that is placed on the phrenic nerve, which runs along the esophagus. This results in synchronous ventilation for the patient.
|
Biphasic Positive Airway Pressure Support (BiPAP)
n=1 Participants
Conventional non-invasive respiratory support
Biphasic Positive Airway Pressure Support (BiPAP): Conventional form of non-invasive respiratory support that does not deliver positive airway pressure in a synchronous fashion.
|
|---|---|---|
|
Length of Non-Invasive Respiratory Support
|
—
|
7.17 hours
|
PRIMARY outcome
Timeframe: Up to 14 days post-operativelyPopulation: All patients who were randomized ended up in the BiPAP group and not the NAVA group.
Outcome measures
| Measure |
Neurally-Adjusted Ventilatory Assist (NAVA)
Synchronized biphasic non-invasive respiratory support
Neurally-Adusted Ventilatory Assist (NAVA): Delivery of positive pressure is based on the electrical activity of the diaphragm (Edi) via a nasogastric (NG) catheter that is placed on the phrenic nerve, which runs along the esophagus. This results in synchronous ventilation for the patient.
|
Biphasic Positive Airway Pressure Support (BiPAP)
n=2 Participants
Conventional non-invasive respiratory support
Biphasic Positive Airway Pressure Support (BiPAP): Conventional form of non-invasive respiratory support that does not deliver positive airway pressure in a synchronous fashion.
|
|---|---|---|
|
Average Post-operative Morphine Dose
|
—
|
NA mg/kg
Standard Deviation NA
Both participants did not receive morphine for pain control
|
PRIMARY outcome
Timeframe: Up to 14 days post-operativelyPopulation: All patients who were randomized ended up in the BiPAP group and not the NAVA group.
Outcome measures
| Measure |
Neurally-Adjusted Ventilatory Assist (NAVA)
Synchronized biphasic non-invasive respiratory support
Neurally-Adusted Ventilatory Assist (NAVA): Delivery of positive pressure is based on the electrical activity of the diaphragm (Edi) via a nasogastric (NG) catheter that is placed on the phrenic nerve, which runs along the esophagus. This results in synchronous ventilation for the patient.
|
Biphasic Positive Airway Pressure Support (BiPAP)
n=2 Participants
Conventional non-invasive respiratory support
Biphasic Positive Airway Pressure Support (BiPAP): Conventional form of non-invasive respiratory support that does not deliver positive airway pressure in a synchronous fashion.
|
|---|---|---|
|
Average Post-operative Lorazepam Dose
|
—
|
0.11 mg/kg
Standard Deviation 0.15
|
PRIMARY outcome
Timeframe: Up to 14 days post-operativelyPopulation: All patients who were randomized ended up in the BiPAP group and not the NAVA group.
Outcome measures
| Measure |
Neurally-Adjusted Ventilatory Assist (NAVA)
Synchronized biphasic non-invasive respiratory support
Neurally-Adusted Ventilatory Assist (NAVA): Delivery of positive pressure is based on the electrical activity of the diaphragm (Edi) via a nasogastric (NG) catheter that is placed on the phrenic nerve, which runs along the esophagus. This results in synchronous ventilation for the patient.
|
Biphasic Positive Airway Pressure Support (BiPAP)
n=2 Participants
Conventional non-invasive respiratory support
Biphasic Positive Airway Pressure Support (BiPAP): Conventional form of non-invasive respiratory support that does not deliver positive airway pressure in a synchronous fashion.
|
|---|---|---|
|
Average Post-operative Dexmedetomidine Dose
|
—
|
6.71 mcg/kg
Standard Deviation 9.49
|
PRIMARY outcome
Timeframe: Up to 14 days post-operativelyPopulation: All patients who were randomized ended up in the BiPAP group and not the NAVA group.
Outcome measures
| Measure |
Neurally-Adjusted Ventilatory Assist (NAVA)
Synchronized biphasic non-invasive respiratory support
Neurally-Adusted Ventilatory Assist (NAVA): Delivery of positive pressure is based on the electrical activity of the diaphragm (Edi) via a nasogastric (NG) catheter that is placed on the phrenic nerve, which runs along the esophagus. This results in synchronous ventilation for the patient.
|
Biphasic Positive Airway Pressure Support (BiPAP)
n=2 Participants
Conventional non-invasive respiratory support
Biphasic Positive Airway Pressure Support (BiPAP): Conventional form of non-invasive respiratory support that does not deliver positive airway pressure in a synchronous fashion.
|
|---|---|---|
|
Average Post-operative Total Fentanyl Dose
|
—
|
8.09 mcg/kg
Standard Deviation 7.06
|
PRIMARY outcome
Timeframe: Up to 14 days post-operativelyPopulation: All patients who were randomized ended up in the BiPAP group and not the NAVA group.
Outcome measures
| Measure |
Neurally-Adjusted Ventilatory Assist (NAVA)
Synchronized biphasic non-invasive respiratory support
Neurally-Adusted Ventilatory Assist (NAVA): Delivery of positive pressure is based on the electrical activity of the diaphragm (Edi) via a nasogastric (NG) catheter that is placed on the phrenic nerve, which runs along the esophagus. This results in synchronous ventilation for the patient.
|
Biphasic Positive Airway Pressure Support (BiPAP)
n=2 Participants
Conventional non-invasive respiratory support
Biphasic Positive Airway Pressure Support (BiPAP): Conventional form of non-invasive respiratory support that does not deliver positive airway pressure in a synchronous fashion.
|
|---|---|---|
|
Average Post-operative PCA Fentanyl Dose
|
—
|
NA boluses
Standard Deviation NA
Both participants did not receive PCA boluses of fentanyl for pain control
|
Adverse Events
Neurally-Adjusted Ventilatory Assist (NAVA)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Biphasic Positive Airway Pressure Support (BiPAP)
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Neurally-Adjusted Ventilatory Assist (NAVA)
Synchronized biphasic non-invasive respiratory support
Neurally-Adusted Ventilatory Assist (NAVA): Delivery of positive pressure is based on the electrical activity of the diaphragm (Edi) via a nasogastric (NG) catheter that is placed on the phrenic nerve, which runs along the esophagus. This results in synchronous ventilation for the patient.
|
Biphasic Positive Airway Pressure Support (BiPAP)
n=2 participants at risk
Conventional non-invasive respiratory support
Biphasic Positive Airway Pressure Support (BiPAP): Conventional form of non-invasive respiratory support that does not deliver positive airway pressure in a synchronous fashion.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Re-intubation
|
—
0/0 • Adverse event data was collected over the span of the patient's hospital stay, specifically up to 14 days post-cardiac surgery.
Adverse events were assessed via review of daily progress notes by both cardiology and cardiac intensive care providers within the electronic medical record (EMR).
|
50.0%
1/2 • Number of events 1 • Adverse event data was collected over the span of the patient's hospital stay, specifically up to 14 days post-cardiac surgery.
Adverse events were assessed via review of daily progress notes by both cardiology and cardiac intensive care providers within the electronic medical record (EMR).
|
Other adverse events
Adverse event data not reported
Additional Information
Mark Lo Galbo, MPH, CCRP
Children's Hospitals and Clinics of Minnesota
Phone: (612)-813-7828
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place