High Flow Nasal Cannula (HFNC) Initiation Flow Rate Study

Bronchiolitis Clinical Trial

Official title:

High Flow Nasal Cannula (HFNC) Initiation Flow Rate Study - A Single Center, Randomized Controlled, Feasibility Study

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT04517344
• Other study ID #: STU-2020-0816
• Status: Suspended
• Phase: N/A
• Start date: December 1, 2020
• Est. completion date: April 2025

Study information

• Verified date: May 2024
• Source: University of Texas Southwestern Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 84
• Est. completion date: April 2025
• Est. primary completion date: April 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Days to 12 Months

Eligibility

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

Related Conditions & MeSH terms

• Bronchiolitis

Intervention

Other:
• Initial Flow Rate
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

Locations

Country	Name	City	State
United States	Children's Health - Children's Medical Center	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
University of Texas Southwestern Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	4 hours of therapy
Secondary	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	24 hours from time of study
Secondary	Length of oxygen support	Number of hours on HFNC; Number of hours on simple nasal cannula	24 hours from time of study
Secondary	Length of stay	Length of stay in the pediatric ICU; Length of stay in the hospital	24 hours from time of study