High Flow Nasal Cannula (HFNC) Initiation Flow Rate Study

The University of Texas System (UT)

Status: Terminated

Conditions: Bronchiolitis

Treatments: Other: Initial Flow Rate

Study type: Interventional

Funder types: Other

Identifiers

NCT04517344

STU-2020-0816

Details and patient eligibility

About

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.

Enrollment: 21 patients

Sex: All

Ages: 7 days to 12 months old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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21 participants in 3 patient groups

Arm 1, HFNC 1 L/kg/min

Experimental group

Description:

The infant that is randomized to the HFNC therapy arm 1 will be placed on high flow at 1 L/kg/min (up to a maximum of 20 L/min) on fraction of inspired oxygen (FiO2) of 21 %. They will remain on FiO2 of 21% for a minimum of 10 minutes while monitoring SpO2. If oxygen saturation (SpO2) is \<90%, FiO2 will be slowly increased to maintain SpO2 ≥ 90 %.

Treatment:

Other: Initial Flow Rate

Arm 2, HFNC 1.5 L/kg/min

Experimental group

Description:

The infant that is randomized to the HFNC therapy arm 2 will be placed on high flow at 1.5 L/kg/min (up to a maximum of 20 L/min) on fraction of inspired oxygen (FiO2) of 21 %. They will remain on FiO2 of 21% for a minimum of 10 minutes while monitoring SpO2. If SpO2 is \<90%, FiO2 will be slowly increased to maintain SpO2 ≥ 90 %.

Treatment:

Other: Initial Flow Rate

Arm 3, HFNC 2 L/kg/min

Experimental group

Description:

The infant that is randomized to the HFNC therapy arm 3 will be placed on high flow at 2 L/kg/min (up to a maximum of 20 L/min) on fraction of inspired oxygen (FiO2) of 21 %. They will remain on FiO2 of 21% for a minimum of 10 minutes while monitoring SpO2. If SpO2 is \<90%, FiO2 will be slowly increased to maintain SpO2 ≥ 90 %.

Treatment:

Other: Initial Flow Rate