High Flow Nasal Cannula (HFNC) Initiation Flow Rate Study

  • STATUS
    Recruiting
  • days left to enroll
    73
  • participants needed
    84
  • sponsor
    University of Texas Southwestern Medical Center
Updated on 10 July 2022

Summary

The investigators propose an open label, non-blinded, single center randomized controlled feasibility study to find the optimal initial HFNC flow rate in children less than 12 months old with clinically diagnosed moderate to severe bronchiolitis. This feasibility study is projected over December 2020 to April 2023. The study is consisted of 3 arms, comparing HFNC therapy at 1 L/kg/min, 1.5 L/kg/min, and 2 L/kg/min (20 L/min max). Moderate to severe bronchiolitis is defined clinician's assessment for the need for ICU level of care.

The primary outcome is treatment response to HFNC therapy defined by RDAI/Respiratory Assessment Change Score (RACS) ≥ 4 at 4 hours of therapy. Secondary outcome measures comprise of treatment failure requiring an escalation of care during the first 24 hours of HFNC therapy, duration of HFNC and simple nasal cannula therapy, duration of simple nasal cannula therapy, hospital and PICU length of stay (LOS), time to treatment failure, and adverse events.

Details
Condition Bronchiolitis
Treatment Initial Flow Rate
Clinical Study IdentifierNCT04517344
SponsorUniversity of Texas Southwestern Medical Center
Last Modified on10 July 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Patients less than 12 months of age
Clinical signs of moderate to severe bronchiolitis defined by American Academy of Pediatrics
Requires ICU level of care by clinicians' discretion
Requiring HFNC support

Exclusion Criteria

Infants who required immediate need for respiratory support such as non-invasive positive pressure ventilation (NIPPV) or invasive ventilation
Congenital heart disease
Immunocompromised state
Upper airway obstruction
Chronic lung disease
Bronchopulmonary dysplasia
Home oxygen therapy requirement
Acute trauma patients
Baseline craniofacial malformations
Admitted to the neonatal or cardiac ICUs
Patients who are admitted to the floor
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