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

Not Applicable

Terminated

Conditions: Respiratory Failure

Interventions: Device: Biphasic Positive Airway Pressure Support (BiPAP)
Device: Neurally-Adusted Ventilatory Assist (NAVA)

Registration Number: NCT03180385

Lead Sponsor: Children's Hospitals and Clinics of Minnesota

Brief Summary: 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: 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.

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 15

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)
1. Laryngomalacia
2. Bronchomalacia
3. Laryngeal web
4. 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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Biphasic Positive Airway Pressure Support (BiPAP)	Biphasic Positive Airway Pressure Support (BiPAP)	Conventional non-invasive respiratory support
Neurally-Adjusted Ventilatory Assist (NAVA)	Neurally-Adusted Ventilatory Assist (NAVA)	Synchronized biphasic non-invasive respiratory support

Primary Outcome Measures

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