RecruitingNot ApplicableNCT06053684

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

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


Sponsor

Montefiore Medical Center

Enrollment

130 participants

Start Date

Dec 18, 2023

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 0 YearsMax Age: 2 Years

Inclusion Criteria2

  • 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 Criteria5

  • 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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Interventions

DEVICEStandard Non-Invasive Mechanical Servo Ventilation

The active comparator arm will utilize a standard non-invasive mode to provide ventilation support

DEVICENeurally-Adjusted Ventilatory Assistance (NAVA) Non-Invasive Mechanical Servo Ventilation

The experimental arm will utilize a NAVA mode to provide non-invasive ventilation support


Locations(1)

Children's Hospital at Montefiore

The Bronx, New York, United States

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NCT06053684


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