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

NCT03180385 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2020-03-10

Study results available
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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

Interventions

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.

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.

Sponsors & Collaborators

  • Children's Hospitals and Clinics of Minnesota

    lead OTHER

Principal Investigators

  • Gretchen A McGuire, RN, MSN, CPNP-AC · Children's Hospitals and Clinics of Minnesota

  • Robert Horvath-Csongradi, MD · Children's Hospitals and Clinics of Minnesota

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
12 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-03-01
Primary Completion
2018-04-10
Completion
2018-04-10
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03180385 on ClinicalTrials.gov