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  • Multicentre, randomised trial to investigate early nasal high—flow therapy in paediatric acute hypoxaemic respiratory failure: a protocol for a randomised controlled trial—a Paediatric Acute respiratory Intervention Study (PARIS 2)

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Paediatrics
Protocol
Multicentre, randomised trial to investigate early nasal high—flow therapy in paediatric acute hypoxaemic respiratory failure: a protocol for a randomised controlled trial—a Paediatric Acute respiratory Intervention Study (PARIS 2)
  1. Donna Franklin1,2,3,4,
  2. Deborah Shellshear4,5,6,
  3. Franz E Babl4,7,8,9,
  4. Luregn J Schlapbach1,2,6,
  5. Ed Oakley4,7,8,9,
  6. Meredith L Borland4,10,11,
  7. Tobias Hoeppner4,10,
  8. Shane George1,2,4,12,
  9. Simon Craig4,13,14,
  10. Jocelyn Neutze4,15,16,
  11. Amanda Williams4,7,8,
  12. Jason Acworth2,4,5,
  13. Hamish McCay17,
  14. Alex Wallace17,
  15. Joerg Mattes18,19,
  16. Vinay Gangathimn4,20,
  17. Mark Wildman4,20,
  18. John F Fraser21,22,
  19. Susan Moloney23,
  20. John Gavranich24,
  21. John Waugh25,
  22. Sue Hobbins26,
  23. Rose Fahy26,
  24. Simon Grew27,
  25. Brenda Gannon28,
  26. Kristen Gibbons1,3,
  27. Stuart Dalziel4,16,29,30,
  28. Andreas Schibler1,2,3,4,6
  29. on behalf of PARIS and PREDICT
  1. 1Paediatric Critical Care Research Group, Child Health Research Centre, The University of Queensland, Brisbane, Queensland, Australia
  2. 2School of Medicine, The University Of Queensland, St Lucia, Queensland, Australia
  3. 3Mater Medical Research Institute, South Brisbane, Queensland, Australia
  4. 4Paediatric Research in Emergency Departments International Collaborative (PREDICT), Parkville, Victoria, Australia
  5. 5Emergency Department, Queensland Children's Hospital, South Brisbane, Queensland, Australia
  6. 6Queensland Children's Hospital, South Brisbane, Queensland, Australia
  7. 7Emergency Department, Royal Childrens Hospital, Parkville, Victoria, Australia
  8. 8Murdoch Children's Research Institute, Melbourne, Victoria, Australia
  9. 9Department of Paediatrics, Faculty of Medicine, Dentistry and Health Services, University of Melbourne, Melbourne, Victoria, Australia
  10. 10Emergency, Princess Margaret Hospital for Children, Subiaco, Western Australia, Australia
  11. 11University of Western Australia, School of Medicine, Divisions of Emergency Medicine and Paediatrics, Crawley, Western Australia, Australia
  12. 12Emergency Department, Gold Coast University Hospital, Southport, Queensland, Australia
  13. 13Emergency Department, Monash Medical Centre Clayton, Clayton, Victoria, Australia
  14. 14Department of Medicine, School of Clinical Science, Monash University, Clayton, Victoria, Australia
  15. 15KidzFirst Middlemore Emergency Department, Middlemore Hospital, Auckland, New Zealand
  16. 16University of Auckland, Auckland, New Zealand
  17. 17Paediatrics, Waikato Hospital, Hamilton, New Zealand
  18. 18Paediatrics, John Hunter Children's Hospital, Hunter Region Mail Centre, New South Wales, Australia
  19. 19University of Newcastle, Priority Research Centre GrowUpWell, Callaghan, New South Wales, Australia
  20. 20Emergency Department, Townsville General Hospital, Townsville, Queensland, Australia
  21. 21Adult Intensive Care Services, The Prince Charles Hospital, Brisbane, Queensland, Australia
  22. 22Critical Care Research Group, The Prince Charles Hospital and University of Queensland, Brisbane, Queensland, Australia
  23. 23Paediatric Department, Gold Coast University Hospital, Southport, Queensland, Australia
  24. 24Paediatrics, Ipswich Hospital, Ipswich, Queensland, Australia
  25. 25Paediatrics, Caboolture Hospital, Caboolture, Queensland, Australia
  26. 26Paediatrics, Prince Charles Hospital, Chermside, Queensland, Australia
  27. 27Paediatrics, Redcliffe Hospital, Redcliffe, Queensland, Australia
  28. 28The University of Queensland, Centre for Business and Economics of Health, St Lucia Qld, Queensland, Australia
  29. 29Starship Children's Health, Emergency Department, Newmarket, New Zealand
  30. 30Department of Surgery and Paediatrics, Child and Youth Health, University of Auckland, Auckland, New Zealand
  1. Correspondence to Donna Franklin; d.franklin2{at}uq.edu.au

Abstract

Introduction Acute hypoxaemic respiratory failure (AHRF) in children is the most frequent reason for non-elective hospital admission. During the initial phase, AHRF is a clinical syndrome defined for the purpose of this study by an oxygen requirement and caused by pneumonia, lower respiratory tract infections, asthma or bronchiolitis. Up to 20% of these children with AHRF can rapidly deteriorate requiring non-invasive or invasive ventilation. Nasal high-flow (NHF) therapy has been used by clinicians for oxygen therapy outside intensive care settings to prevent escalation of care. A recent randomised trial in infants with bronchiolitis has shown that NHF therapy reduces the need to escalate therapy. No similar data is available in the older children presenting with AHRF. In this study we aim to investigate in children aged 1 to 4 years presenting with AHRF if early NHF therapy compared with standard-oxygen therapy reduces hospital length of stay and if this is cost-effective compared with standard treatment.

Methods and analysis The study design is an open-labelled randomised multicentre trial comparing early NHF and standard-oxygen therapy and will be stratified by sites and into obstructive and non-obstructive groups. Children aged 1 to 4 years (n=1512) presenting with AHRF to one of the participating emergency departments will be randomly allocated to NHF or standard-oxygen therapy once the eligibility criteria have been met (oxygen requirement with transcutaneous saturation <92%/90% (dependant on hospital standard threshold), diagnosis of AHRF, admission to hospital and tachypnoea ≥35 breaths/min). Children in the standard-oxygen group can receive rescue NHF therapy if escalation is required. The primary outcome is hospital length of stay. Secondary outcomes will include length of oxygen therapy, proportion of intensive care admissions, healthcare resource utilisation and associated costs. Analyses will be conducted on an intention-to-treat basis.

Ethics and dissemination Ethics approval has been obtained in Australia (HREC/15/QRCH/159) and New Zealand (HDEC 17/NTA/135). The trial commenced recruitment in December 2017. The study findings will be submitted for publication in a peer-reviewed journal and presented at relevant conferences. Authorship of all publications will be decided by mutual consensus of the research team.

Trial registration number ACTRN12618000210279

  • paediatric
  • children
  • respiratory disease
  • respiratory support
  • oxygen therapy

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

https://doi.org/10.1136/bmjopen-2019-030516

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    Footnotes

    • Collaborators Steering Committee: Each site is represented by at least one member for the steering group. Data and Safety Monitoring Board (DSMB): Phil Sargent, Scott Burgess, Kristen Gibbons (stat).

    • Contributors DF, AS, DS, SD and FEB were responsible for identifying the research question and contributing to the drafting of the protocol. All Authors, including DF, AS, DS, FEB, LJS, EO, MLB, TH, SG, SC, JN, VG, MW, JA, HM, AW, JM, JFF, SM, JG, JW, SH, RF, SG, BG, KG have contributed to the development of the protocol and study design. DF was responsible for drafting this manuscript, with comments and feedback from all other authors. KG provided expert statistical advice and input, BG developed the health economic measures and analysis. All authors attest to having approved the final manuscript. DF and AS take responsibility for the manuscript as a whole.

    • Funding This research is supported by a project grant from Thrasher Award (United States), the Children’s Hospital Foundation (Brisbane, Australia), the Queensland Emergency Medical Research Foundation and the National Health and Medical Research Council (GNT1139903). Funding support from Perth Children’s Hospital Foundation. OptiFlow equipment and consumables have been supplied free of charge for this study by Fisher and Paykel Health Care, Auckland, New Zealand.

    • Competing interests DF, SG, AS and SD received travel support from Fisher and Paykel Healthcare. All other authors have no conflicts to disclose. Fisher and Paykel have provided equipment and consumables for the study but have had no input in the study design.

    • Patient consent for publication Not required.

    • Ethics approval The study protocol has been reviewed and approved by ethics committees in Australia (Children’s Health Queensland Human Research Ethics Committee, HREC/15/QRCH/159 and Ethics Committee of The University of Queensland 2016001491) and New Zealand (Health and Disability Ethics Committee HDEC 17/NTA/135).

    • Provenance and peer review Not commissioned; externally peer reviewed.