Early high flow nasal cannula therapy in bronchiolitis, a prospective randomised control trial (protocol): a Paediatric Acute Respiratory Intervention Study (PARIS)

Franklin, Donna, Dalziel, Stuart, Schlapbach, Luregn J., Babl, Franz E., Oakley, Ed, Craig, Simon S., Furyk, Jeremy S., Neutze, Jocelyn, Sinn, Kam, Whitty, Jennifer A., Gibbons, Kristen, Fraser, John, and Schibler, Andreas (2015) Early high flow nasal cannula therapy in bronchiolitis, a prospective randomised control trial (protocol): a Paediatric Acute Respiratory Intervention Study (PARIS). BMC Pediatrics, 15. p. 183.

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Abstract

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 FiO(2) >= 40 % to maintain SpO(2) >= 92 % (or >= 94 %) or oxygen requirement in standard subnasal oxygen therapy arm exceeds > 2L/min to maintain SpO(2) >= 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.

Item ID: 41930
Item Type: Article (Research - C1)
ISSN: 1471-2431
Additional Information:

This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

Funders: National Health and Medical Research Council of Australia (NHMRC), Queensland Emergency Medicine Research Foundation (QEMRF), Ipswich Hospital Foundation, Gold Coast University Hospital, Queensland Health, Victorian Government's Infrastructure Support Program, Royal Children's Hospital Foundation, Health Research Council of New Zealand
Projects and Grants: NHMRC APP1081739, NHMRC GNT1058560
Date Deposited: 08 Dec 2015 15:40
FoR Codes: 11 MEDICAL AND HEALTH SCIENCES > 1114 Paediatrics and Reproductive Medicine > 111403 Paediatrics @ 50%
11 MEDICAL AND HEALTH SCIENCES > 1103 Clinical Sciences > 110305 Emergency Medicine @ 50%
SEO Codes: 92 HEALTH > 9205 Specific Population Health (excl. Indigenous Health) > 920501 Child Health @ 100%
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