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

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

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.

Study Overview

• Status: Terminated
• Conditions: Respiratory Failure
• Intervention / Treatment: Device: Neurally-Adusted Ventilatory Assist (NAVA); Device: Biphasic Positive Airway Pressure Support (BiPAP)

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.

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55404
      • Children's Hospitals and Clinics of Minnesota

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 1 year (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Neurally-Adjusted Ventilatory Assist (NAVA); Synchronized biphasic non-invasive respiratory support	Device: 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.
ACTIVE_COMPARATOR: Biphasic Positive Airway Pressure Support (BiPAP); Conventional non-invasive respiratory support	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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Children's Hospitals and Clinics of Minnesota
• Investigators: Principal Investigator: Gretchen A McGuire, RN, MSN, CPNP-AC, Children's Hospitals and Clinics of Minnesota; Principal Investigator: Robert Horvath-Csongradi, MD, Children's Hospitals and Clinics of Minnesota

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 1, 2017
• Primary Completion (ACTUAL): April 10, 2018
• Study Completion (ACTUAL): April 10, 2018

Study Registration Dates

• First Submitted: June 6, 2017
• First Submitted That Met QC Criteria: June 6, 2017
• First Posted (ACTUAL): June 8, 2017

Study Record Updates

• Last Update Posted (ACTUAL): March 10, 2020
• Last Update Submitted That Met QC Criteria: March 2, 2020
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: Pediatrics; Cardiac Surgery; BiPAP; NAVA
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Respiratory Insufficiency
• Other Study ID Numbers: 1701-008

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes