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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
21
Patients placed on High Flow Nasal Cannula by treating physician will be randomized to initial flow rates of 1 L/kg/min, 1.5 L/kg/min, or 2 L/kg/min
Children's Health - Children's Medical Center
Dallas, Texas, United States
Treatment response to HFNC Therapy
Determined by Respiratory Distress Assessment Instrument (RDAI) score and Respiratory Assessment Change Score (RACS) and heart rate improvement by 10%. The RDAI score assigns a score base on respiratory rate (RR), extent of wheezing, and retractions. It ranges from 0-17, higher score indicates severe bronchiolitis. To determine RACS: * A decrease in RR by 10% is +1 change unit. Increase of 10% was defined as -1 change unit. * Subsequent RDAI score is subtracted from the previous RDAI score to obtain the change. (ie. if initial score is 7 and the reassessment score is 3, the patient has a score of +4) Positive score is indicative of improvement, and negative score demonstrates deterioration. The overall RACS is calculated as the sum of change scores. Improvement is defined as RACS ≥ 4 positive units. No improvement was defined as RACS \< 4 positive units.
Time frame: 4 hours of therapy
Treatment failure to HFNC Therapy
* Need for an increase in initial flow setting as determined by treating physician during the first 24 hours of hospitalization * Escalation to other forms of non-invasive ventilatory support (i.e. NCPAP or BIPAP) * Need for invasive ventilation
Time frame: 24 hours from time of study
Length of oxygen support
* Number of hours on HFNC * Number of hours on simple nasal cannula
Time frame: 24 hours from time of study
Length of stay
* Length of stay in the pediatric ICU * Length of stay in the hospital
Time frame: 24 hours from time of study
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