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

NCT03180385 | Terminated Results DMC FDA Device

• 1 other identifier: 1701-008
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Respiratory Failure

Keywords

NAVA; BiPAP; Pediatrics; Cardiac Surgery

Outcome Measures

Primary Outcomes (10)

• 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

Study Arms (2)

Neurally-Adjusted Ventilatory Assist (NAVA)

EXPERIMENTAL

Synchronized biphasic non-invasive respiratory support

Device: Neurally-Adusted Ventilatory Assist (NAVA)

Biphasic Positive Airway Pressure Support (BiPAP)

ACTIVE COMPARATOR

Conventional non-invasive respiratory support

Device: Biphasic Positive Airway Pressure Support (BiPAP)

Interventions

Neurally-Adusted Ventilatory Assist (NAVA) 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.

Neurally-Adjusted Ventilatory Assist (NAVA)

Biphasic Positive Airway Pressure Support (BiPAP) DEVICE

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

Biphasic Positive Airway Pressure Support (BiPAP)

Eligibility Criteria

• Age: Up to 12 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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
• to 12 months of age

You may not qualify if:

• 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
• Other chromosomal abnormality (non-Down syndrome)
• Chronic lung disease
• Pre-operative non-invasive respiratory support

Sponsors & Collaborators

• Children's Hospitals and Clinics of Minnesota: lead

Study Sites (1)

Children's Hospitals and Clinics of Minnesota

Minneapolis, Minnesota, 55404, United States

Location

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Results Point of Contact

• Title: Mark Lo Galbo, MPH, CCRP
• Organization: Children's Hospitals and Clinics of Minnesota

mark.logalbo@childrensmn.org

(612)-813-7828

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2017
• First Posted: June 8, 2017
• Study Start: March 1, 2017
• Primary Completion: April 10, 2018
• Study Completion: April 10, 2018
• Last Updated: March 10, 2020
• Results First Posted: October 15, 2019

Record last verified: 2019-09

Locations

US (1)