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