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

Children's Hospitals and Clinics of Minnesota

Status

Terminated

Conditions

Respiratory Failure

Treatments

Device: Biphasic Positive Airway Pressure Support (BiPAP)

Device: Neurally-Adusted Ventilatory Assist (NAVA)

Study type

Interventional

Funder types

Other

Identifiers

NCT03180385

1701-008

Details and patient eligibility

About

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.

Full 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.

Enrollment

15 patients

Sex

All

Ages

Under 12 months old

Volunteers

No Healthy Volunteers

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