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Suspended NCT06053684

Non-Invasive Ventilation Versus Neurally-Adjusted Ventilatory Assistance (NAVA) for the Treatment of Bronchiolitis

Conditions: Bronchiolitis

Sex: All
Ages: 0 Years – 2 Years
Healthy volunteers: No
Phase: NA
Enrollment: 130
Sponsor: Montefiore Medical Center

Location: Children's Hospital at Montefiore The Bronx New York

Summary

This project aims to answer whether the use of a Neurally-Adjusted Ventilatory Assistance mode for non-invasive ventilation in pediatric patients with bronchiolitis results in improved comfort and reduced escalations in therapy (including intubation) when compared to using a standard mode of non-invasive ventilation. Neurally-Adjusted Ventilatory Assistance (NAVA) has been shown to result in greater synchrony then the standard mode of non-invasive ventilation. The study team hypothesizes that this improved synchrony can result in important clinical improvements when NAVA is used to treat children with bronchiolitis.

Eligibility Criteria

Inclusion Criteria: * Patients under the age of two years old with a diagnosis of bronchiolitis presenting to the pediatric ICU * Patient's provider believes there is equipoise between the use of NAVA or conventional non-invasive ventilation for the patient Exclusion Criteria: * Patients unable to utilize a nasogastric tube * Patients with a diagnosis of chronic lung disease, cyanotic heart lesions, or congestive heart failure * Patients with hypotonia * Patients likely to require imminent intubation: \>0.60 Fraction of Inspired Oxygen (FiO2); Carbon Dioxide (CO2) \> 60, frequent apneas, clinician determines patient unlikely to tolerate non-invasive modality) * Patients with hemodynamic instability, defined as the need for vasoactive medication

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT06053684). StuddyBuddy aggregates publicly available trial information.