NAVA Versus BiPAP Non-Invasive Respiratory Support in Infants Following Congenital Heart Surgery

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Neurally Adjusted Ventilatory Assist (NAVA) Versus Conventional Biphasic Positive End Expiratory Pressure (BiPAP) Non-Invasive Respiratory Support in Infants Following Congenital Heart Surgery

Conditions
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Respiratory Failure

Intervention / Treatment
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* Device: Neurally-Adusted Ventilatory Assist (NAVA)
* Device: Biphasic Positive Airway Pressure Support (BiPAP)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Postoperative cardiac surgery patients admitted to the Cardiovascular Care Center (CVCC) at Children's Hospitals and Clinics of Minnesota Recommended for non-invasive (NIV) respiratory support following extubation, per provider discretion 0 to 12 months of age Exclusion Criteria: Documented airway malformation (congenital or acquired) Laryngomalacia Bronchomalacia Laryngeal web Tracheal or bronchial rings (complete or incomplete) Documented ENT abnormality Documented central apnea Patients who are overly sedated, per provider discretion Tracheostomy in place at time of cardiac surgery Documented phrenic nerve paralysis (Note: Vocal cord paresis and paralysis will not be an exclusion) Other chromosomal abnormality (non-Down syndrome) Chronic lung disease Pre-operative non-invasive respiratory support

Ages Eligible for Study
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Maximum Age: 12 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Neurally-Adjusted Ventilatory Assist (NAVA)<br>Synchronized biphasic non-invasive respiratory support | Device: Neurally-Adusted Ventilatory Assist (NAVA)<br>* 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.<br>|
| Active Comparator: Biphasic Positive Airway Pressure Support (BiPAP)<br>Conventional non-invasive respiratory support | Device: Biphasic Positive Airway Pressure Support (BiPAP)<br>* Conventional form of non-invasive respiratory support that does not deliver positive airway pressure in a synchronous fashion.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average Post-operative Midazolam Dose |  | Up to 14 days post-operatively | 
| Post-operative Pain Scores-FLACC | FLACC (Face, Legs, Activity, Cry, Consolability) scale | Up to 14 days post-operatively | 
| Post-operative Sedation Scores-SBS | SBS (State Behavioral Scale) | Up to 14 days post-operatively | 
| Length of Intubation |  | Up to 14 days post-operatively | 
| Length of Non-Invasive Respiratory Support |  | Up to 14 days post-operatively | 
| Average Post-operative Morphine Dose |  | Up to 14 days post-operatively | 
| Average Post-operative Lorazepam Dose |  | Up to 14 days post-operatively | 
| Average Post-operative Dexmedetomidine Dose |  | Up to 14 days post-operatively | 
| Average Post-operative Total Fentanyl Dose |  | Up to 14 days post-operatively | 
| Average Post-operative PCA Fentanyl Dose |  | Up to 14 days post-operatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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NAVA, BiPAP, Pediatrics, Cardiac Surgery