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

NCT ID: NCT03180385

Last Updated: 2020-03-10

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-01
• Study Completion Date: 2018-04-10

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.

Conditions

Respiratory Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Neurally-Adjusted Ventilatory Assist (NAVA)

Synchronized biphasic non-invasive respiratory support

Group Type: EXPERIMENTAL

Neurally-Adusted Ventilatory Assist (NAVA)

Intervention Type: DEVICE

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

Group Type: ACTIVE_COMPARATOR

Biphasic Positive Airway Pressure Support (BiPAP)

Intervention Type: DEVICE

Conventional form of non-invasive respiratory support that does not deliver positive airway pressure in a synchronous fashion.

Interventions

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.

Intervention Type: DEVICE

Biphasic Positive Airway Pressure Support (BiPAP)

Conventional form of non-invasive respiratory support that does not deliver positive airway pressure in a synchronous fashion.

Intervention Type: DEVICE

Eligibility Criteria

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

• Maximum Eligible Age: 12 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Children's Hospitals and Clinics of Minnesota

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gretchen A McGuire, RN, MSN, CPNP-AC

Role: PRINCIPAL_INVESTIGATOR

Children's Hospitals and Clinics of Minnesota

Robert Horvath-Csongradi, MD

Role: PRINCIPAL_INVESTIGATOR

Children's Hospitals and Clinics of Minnesota

Locations

Children's Hospitals and Clinics of Minnesota

Minneapolis, Minnesota, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

1701-008

Identifier Type: -

Identifier Source: org_study_id