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Early high flow nasal cannula therapy in bronchiolitis, a prospective randomised control trial (protocol): A
Donna Franklin1,2,3,4, Stuart Dalziel5,6,7, Luregn J Schlapbach8,9,10,11
1Paediatric Critical Care Research Group, Lady Cilento Children's Hospital and The University of Queensland, Brisbane, Australia. d.franklin2@uq.edu.au.
Insights
High Flow Nasal Cannula (HFNC) therapy may improve outcomes for infants with bronchiolitis. This study compares HFNC to standard oxygen to assess treatment effectiveness and patient care.
Area of Science:
- Pediatric Emergency Medicine
- Respiratory Care
- Clinical Trials
Background:
- Bronchiolitis is a leading cause of pediatric hospital admissions, with significant healthcare burden.
- Current pharmaceutical treatments show limited efficacy in improving outcomes.
- Non-invasive respiratory support, like High Flow Nasal Cannula (HFNC) therapy, may prevent disease progression.
Purpose of the Study:
- To definitively assess the efficacy of HFNC therapy compared to standard subnasal oxygen in treating infants with bronchiolitis.
- To evaluate the impact of early respiratory support on disease progression and healthcare utilization.
Main Methods:
- A prospective, multi-center randomized trial involving 17 hospitals in Australia and New Zealand.
- Comparison of standard subnasal oxygen therapy with HFNC therapy in infants presenting with bronchiolitis.
- Primary outcome: treatment failure, defined by escalation of care criteria. Secondary outcomes: transfer, ICU admission, length of stay, ventilation needs, and costs.
Main Results:
- This section is not available in the provided abstract.
Conclusions:
- This large multicenter randomized trial is designed to provide definitive evidence on HFNC therapy's efficacy in bronchiolitis treatment.
- Results will inform clinical practice regarding the use of HFNC versus standard oxygen for pediatric bronchiolitis.
Background:
Bronchiolitis imposes the largest health care burden on non-elective paediatric hospital admissions worldwide, with up to 15 % of cases requiring admission to intensive care. A number of previous studies have failed to show benefit of pharmaceutical treatment in respect to length of stay, reduction in PICU admission rates or intubation frequency. The early use of non-invasive respiratory support devices in less intensive scenarios to facilitate earlier respiratory support may have an impact on outcome by avoiding progression of the disease process. High Flow Nasal Cannula (HFNC) therapy has emerged as a new method to provide humidified air flow to deliver a non-invasive form of positive pressure support with titratable oxygen fraction. There is a lack of high-grade evidence on use of HFNC therapy in bronchiolitis.
Methods/Design:
Prospective multi-centre randomised trial comparing standard treatment (standard subnasal oxygen) and High Flow Nasal Cannula therapy in infants with bronchiolitis admitted to 17 hospitals emergency departments and wards in Australia and New Zealand, including 12 non-tertiary regional/metropolitan and 5 tertiary centres. The primary outcome is treatment failure; defined as meeting three out of four pre-specified failure criteria requiring escalation of treatment or higher level of care; i) heart rate remains unchanged or increased compared to admission/enrolment observations, ii) respiratory rate remains unchanged or increased compared to admission/enrolment observations, iii) oxygen requirement in HFNC therapy arm exceeds FiO2 ≥ 40 % to maintain SpO2 ≥ 92 % (or ≥94 %) or oxygen requirement in standard subnasal oxygen therapy arm exceeds >2L/min to maintain SpO2 ≥ 92 % (or ≥94 %), and iv) hospital internal Early Warning Tool calls for medical review and escalation of care. Secondary outcomes include transfer to tertiary institution, admission to intensive care, length of stay, length of oxygen treatment, need for non-invasive/invasive ventilation, intubation, adverse events, and cost.
Discussion:
This large multicenter randomised trial will allow the definitive assessment of the efficacy of HFNC therapy as compared to standard subnasal oxygen in the treatment of bronchiolitis.
Trial Registration:
The trial is registered with the Australian and New Zealand Clinical Trials Registry ACTRN12613000388718 (registered on 10 April 2013).
