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)
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...
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BMJ Publishing Group
2019-12-01
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| author | Franz E Babl Simon Craig Ed Oakley Meredith L Borland Jocelyn Neutze John F Fraser Brenda Gannon Kristen Gibbons Shane George Luregn J Schlapbach Stuart Dalziel Andreas Schibler Donna Franklin Amanda Williams Deborah Shellshear Tobias Hoeppner Jason Acworth Hamish McCay Alex Wallace Joerg Mattes Vinay Gangathimn Mark Wildman Susan Moloney John Gavranich John Waugh Sue Hobbins Rose Fahy Simon Grew |
| author_facet | Franz E Babl Simon Craig Ed Oakley Meredith L Borland Jocelyn Neutze John F Fraser Brenda Gannon Kristen Gibbons Shane George Luregn J Schlapbach Stuart Dalziel Andreas Schibler Donna Franklin Amanda Williams Deborah Shellshear Tobias Hoeppner Jason Acworth Hamish McCay Alex Wallace Joerg Mattes Vinay Gangathimn Mark Wildman Susan Moloney John Gavranich John Waugh Sue Hobbins Rose Fahy Simon Grew |
| author_sort | Franz E Babl |
| collection | DOAJ |
| description | 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 |
| format | Article |
| id | doaj-art-9a15f20da78b408fb81f9effa2bbbe0c |
| institution | Kabale University |
| issn | 2044-6055 |
| language | English |
| publishDate | 2019-12-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-9a15f20da78b408fb81f9effa2bbbe0c2024-12-01T14:45:09ZengBMJ Publishing GroupBMJ Open2044-60552019-12-0191210.1136/bmjopen-2019-030516Multicentre, 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)Franz E Babl0Simon Craig1Ed Oakley2Meredith L Borland3Jocelyn Neutze4John F Fraser5Brenda Gannon6Kristen Gibbons7Shane George8Luregn J Schlapbach9Stuart Dalziel10Andreas Schibler11Donna Franklin12Amanda Williams13Deborah Shellshear14Tobias Hoeppner15Jason Acworth16Hamish McCay17Alex Wallace18Joerg Mattes19Vinay Gangathimn20Mark Wildman21Susan Moloney22John Gavranich23John Waugh24Sue Hobbins25Rose Fahy26Simon Grew27Departments of Pediatrics and Critical Care, University of Melbourne, Murdoch Children`s Research Institute and Royal Children`s Hospital, Parkville, Victoria, Australia1 Paediatric Emergency Department, Monash Medical Centre Clayton, Clayton, Victoria, AustraliaDepartment of Emergency Medicine, The Royal Children’s Hospital, Parkville, Victoria, AustraliaDepartment of Emergency Medicine, Perth Children’s Hospital, Perth, Western Australia, AustraliaKidz first Middlemore Hospital, Auckland, New Zealand5 The University of Queensland Child Health Research Centre, School of Medicine, Brisbane, Queensland, AustraliaThe University of Queensland, Centre for Business and Economics of Health, St Lucia Qld, Queensland, AustraliaChild Health Research Centre, Mater Medical Research Institute, South Brisbane, Queensland, AustraliaDivision of Emergency Medicine and Children’s Critical Care, Gold Coast University Hospital, Gold Coast, Queensland, AustraliaChild Health Research Centre, The University of Queensland, South Brisbane, Queensland, AustraliaChildren’s Emergency Department, Starship Children’s Hospital, Auckland, New Zealand3 Paediatric Critical Care Research Group, The University of Queensland Child Health Research Centre, South Brisbane, Queensland, Australia9 School of Health Sciences, Institute of Mental Health, University of Nottingham, Nottingham, UKClinical Sciences, Murdoch Children’s Research Institute, Parkville, Victoria, AustraliaEmergency Department, Queensland Children`s Hospital, South Brisbane, Queensland, Australia7 Emergency Medicine, Perth Children`s Hospital, Nedlands, Western Australia, Australia1 Emergency Department, Queensland Children’s Hospital, Children`s Health Queensland Hospital and Health Service, South Brisbane, Queensland, AustraliaPaediatrics, Waikato Hospital, Hamilton, New ZealandPaediatrics, Waikato Hospital, Hamilton, New ZealandSchool of Medicine and Public Health, The University of Newcastle, Callaghan, New South Wales, AustraliaPaediatric Research in Emergency Departments International Collaborative (PREDICT), Parkville, Victoria, AustraliaPaediatric Research in Emergency Departments International Collaborative (PREDICT), Parkville, Victoria, AustraliaPopulation Health Sciences Institute, Newcastle University, Newcastle upon Tyne, UKPaediatrics, Ipswich Hospital, Ipswich, Queensland, AustraliaPaediatrics, Caboolture Hospital, Caboolture, Queensland, AustraliaPaediatrics, Prince Charles Hospital, Chermside, Queensland, AustraliaPaediatrics, Prince Charles Hospital, Chermside, Queensland, AustraliaPaediatrics, Redcliffe Hospital, Redcliffe, Queensland, AustraliaIntroduction 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 ACTRN12618000210279https://bmjopen.bmj.com/content/9/12/e030516.full |
| spellingShingle | Franz E Babl Simon Craig Ed Oakley Meredith L Borland Jocelyn Neutze John F Fraser Brenda Gannon Kristen Gibbons Shane George Luregn J Schlapbach Stuart Dalziel Andreas Schibler Donna Franklin Amanda Williams Deborah Shellshear Tobias Hoeppner Jason Acworth Hamish McCay Alex Wallace Joerg Mattes Vinay Gangathimn Mark Wildman Susan Moloney John Gavranich John Waugh Sue Hobbins Rose Fahy Simon Grew 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) BMJ Open |
| title | 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) |
| title_full | 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) |
| title_fullStr | 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) |
| title_full_unstemmed | 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) |
| title_short | 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) |
| title_sort | 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 |
| url | https://bmjopen.bmj.com/content/9/12/e030516.full |
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