An interventional study of Neurally-Adusted Ventilatory Assist (NAVA) and Biphasic Positive Airway Pressure Support (BiPAP) in Respiratory Failure, sponsored by Children's Hospitals and Clinics of Minnesota. Terminated at 1 site in United States. Open to participants aged Up to 12 Months. Per ClinicalTrials.gov, last updated 2020-03-10.
Sponsored by Children's Hospitals and Clinics of Minnesota · Not applicable, Interventional, and Treatment
Pediatric patients often require prolonged mechanical ventilation after cardiac surgery which comes with many undesirable effects. As a result, neurally-adjusted ventilatory assist (NAVA) and biphasic positive airway pressure support (BiPAP) have been developed as non-invasive alternatives to providing respiratory support post-operatively. The investigators hypothesize that providing synchronized biphasic support with NAVA will be associated with shorter duration of non-invasive respiratory support, less sedation requirements, and reduced length of hospital stay. This is a prospective, randomized study. Subjects are randomized to receive either NAVA or BiPAP following their cardiothoracic surgery.
Mechanical ventilation is often very necessary in the care of critically ill pediatric patients. However, it comes with many different complications that include chronic lung disease, tissue damage, and ventilator-associated pneumonia. Over time, we have increased our understanding of how a child's physiology interacts with a ventilator and this has led to two different non-invasive forms of respiratory support: bilevel positive air pressure (BiPAP) and neurally adjusted ventilator assist (NAVA). While both modalities come with a lot of benefits such as improved gas exchange, decreased respiratory and heart rate and decreased inspiratory work of breathing, NAVA has the ability to provide synchronous ventilatory support due to the electrical activity of the diaphragm.
The purpose of this study is to compare clinical outcomes following use of NAVA versus BiPAP in patients undergoing cardiac surgery, Specifically, comparisons of non-invasive respiratory support, duration of sedation, and length of hospital stay. The investigators hypothesize that the use of NAVA will lead to a shorter duration of non-invasive respiratory support, less sedation requirements, and reduced length of hospital stay compared to the use of BiPAP.
This is a single-site, prospective randomized study. Subjects are randomized into two arms: those who receive NAVA and those who receive BiPAP post-operatively.
Subjects will be followed for up to 14 days post-operatively or until they are discharged, whichever comes first. Pain medication administered, FLACC (Face, Legs, Activity, Cry, Consolability), and SBS (State Behavioral Scale) scores are recorded daily for up to 14 days.
1,650 studies on the registry are indexed under Respiratory Insufficiency; 296 are open to participants now.
This study's enrollment of 15 is below the median of 55 across 1,043 interventional studies indexed under Respiratory Insufficiency.
Browse Respiratory Insufficiency studies →Children's Hospitals and Clinics of Minnesota is the lead sponsor of 49 studies on the registry; 4 are open to participants now.
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Exclusion Criteria:
Documented airway malformation (congenital or acquired)
Synchronized biphasic non-invasive respiratory support
Device: Neurally-Adusted Ventilatory Assist (NAVA)
Conventional non-invasive respiratory support
Device: Biphasic Positive Airway Pressure Support (BiPAP)
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.
Conventional form of non-invasive respiratory support that does not deliver positive airway pressure in a synchronous fashion.
Average Post-operative Midazolam Dose
Time frame: Up to 14 days post-operatively
Post-operative Pain Scores-FLACC
FLACC (Face, Legs, Activity, Cry, Consolability) scale
Time frame: Up to 14 days post-operatively
Post-operative Sedation Scores-SBS
SBS (State Behavioral Scale)
Time frame: Up to 14 days post-operatively
Length of Intubation
Time frame: Up to 14 days post-operatively
Length of Non-Invasive Respiratory Support
Time frame: Up to 14 days post-operatively
Average Post-operative Morphine Dose
Time frame: Up to 14 days post-operatively
Average Post-operative Lorazepam Dose
Time frame: Up to 14 days post-operatively
Average Post-operative Dexmedetomidine Dose
Time frame: Up to 14 days post-operatively
Average Post-operative Total Fentanyl Dose
Time frame: Up to 14 days post-operatively
Average Post-operative PCA Fentanyl Dose
Time frame: Up to 14 days post-operatively
| Milestone | Neurally-Adjusted Ventilatory Assist (NAVA) | Biphasic Positive Airway Pressure Support (BiPAP) |
|---|---|---|
| Started | 0 | 2 |
| Completed | 0 | 2 |
| Not completed | 0 | 0 |
| mg/kg | Neurally-Adjusted Ventilatory Assist (NAVA) | Biphasic Positive Airway Pressure Support (BiPAP) |
|---|---|---|
| Average Post-operative Midazolam Dose | — | 0.035 ± 0.007 |
FLACC (Face, Legs, Activity, Cry, Consolability) scale
No measurements were reported for this outcome.
SBS (State Behavioral Scale)
No measurements were reported for this outcome.
| hours | Neurally-Adjusted Ventilatory Assist (NAVA) | Biphasic Positive Airway Pressure Support (BiPAP) |
|---|---|---|
| Length of Intubation | — | 37.24 ± 3.87 |
| hours | Neurally-Adjusted Ventilatory Assist (NAVA) | Biphasic Positive Airway Pressure Support (BiPAP) |
|---|---|---|
| Length of Non-Invasive Respiratory Support | — | 7.17 |
| mg/kg | Neurally-Adjusted Ventilatory Assist (NAVA) | Biphasic Positive Airway Pressure Support (BiPAP) |
|---|---|---|
| Average Post-operative Morphine Dose | — | NA ± NA |
| mg/kg | Neurally-Adjusted Ventilatory Assist (NAVA) | Biphasic Positive Airway Pressure Support (BiPAP) |
|---|---|---|
| Average Post-operative Lorazepam Dose | — | 0.11 ± 0.15 |
| mcg/kg | Neurally-Adjusted Ventilatory Assist (NAVA) | Biphasic Positive Airway Pressure Support (BiPAP) |
|---|---|---|
| Average Post-operative Dexmedetomidine Dose | — | 6.71 ± 9.49 |
| mcg/kg | Neurally-Adjusted Ventilatory Assist (NAVA) | Biphasic Positive Airway Pressure Support (BiPAP) |
|---|---|---|
| Average Post-operative Total Fentanyl Dose | — | 8.09 ± 7.06 |
| boluses | Neurally-Adjusted Ventilatory Assist (NAVA) | Biphasic Positive Airway Pressure Support (BiPAP) |
|---|---|---|
| Average Post-operative PCA Fentanyl Dose | — | NA ± NA |
Collected over Adverse event data was collected over the span of the patient's hospital stay, specifically up to 14 days post-cardiac surgery.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Neurally-Adjusted Ventilatory Assist (NAVA) | — | — | — |
| Biphasic Positive Airway Pressure Support (BiPAP) | 0/2 (0%) | 1/2 (50%) | 0/2 (0%) |
| Event | Neurally-Adjusted Ventilatory Assist (NAVA) | Biphasic Positive Airway Pressure Support (BiPAP) |
|---|---|---|
| Re-intubationRespiratory, thoracic and mediastinal disorders | — | 1/2 |
No patients who were enrolled in the study and needed non-invasive respiratory support post-cardiac surgery were randomized to NAVA, only BiPAP.
| Age, Continuous(years) | Neurally-Adjusted Ventilatory Assist (NAVA) | Biphasic Positive Airway Pressure Support (BiPAP) | Total |
|---|---|---|---|
| Mean | — | 0.46 ± 0.04 | 0.46 ± 0.04 |
| Sex: Female, Male(Participants) | Neurally-Adjusted Ventilatory Assist (NAVA) | Biphasic Positive Airway Pressure Support (BiPAP) | Total |
|---|---|---|---|
| Female | — | 1 | 1 |
| Male | — | 1 | 1 |
| Race and Ethnicity Not Collected(Participants) | Neurally-Adjusted Ventilatory Assist (NAVA) | Biphasic Positive Airway Pressure Support (BiPAP) | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Region of Enrollment(participants) | Neurally-Adjusted Ventilatory Assist (NAVA) | Biphasic Positive Airway Pressure Support (BiPAP) | Total |
|---|---|---|---|
| United States | — | 2 | 2 |
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Children's Hospitals and Clinics of Minnesota