NAVA Versus BiPAP Non-Invasive Respiratory Support in Infants Following Congenital Heart Surgery
Stopped early · Not applicable
Conditions studied: Respiratory Failure
In brief
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.
Key facts
- Study ID
- NCT03180385
- Run by
- Children's Hospitals and Clinics of Minnesota
- People needed
- 15
- Starts
- 2017-03-01
- Expected to finish
- 2018-04-10
- Last updated by the study team
- 2020-03-10
Who can join
Age: any, up to 1. Sex: any. Healthy volunteers: not accepted.
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
- 0 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
- 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
Where it is running
- Children's Hospitals and Clinics of Minnesota — Minneapolis, Minnesota, United States
Full record on ClinicalTrials.gov
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