Transnasal Humidified Rapid Insufflation Ventilatory Exchange in children requiring emergent intubation (Kids THRIVE): a protocol for a randomised controlled trial.

Administration, Intranasal Airway Management Apnea / physiopathology Carbon Dioxide / blood Child Emergency Service, Hospital Humans Humidifiers Insufflation / methods Intensive Care Units, Pediatric Intubation, Intratracheal / adverse effects Multicenter Studies as Topic Oxygen Inhalation Therapy / methods Randomized Controlled Trials as Topic
airway management apnoeic oxygenation intubation nasal high-flow paediatrics transnasal humidified rapid insufflation ventilatory exchange

Journal

BMJ open
ISSN: 2044-6055
Titre abrégé: BMJ Open
Pays: England
ID NLM: 101552874

Informations de publication

Date de publication:
20 02 2019
Historique:
entrez: 22 2 2019
pubmed: 23 2 2019
medline: 28 3 2020
Statut: epublish

Résumé

Emergency intubation of children with abnormal respiratory or cardiac physiology is a high-risk procedure and associated with a high incidence of adverse events including hypoxemia. Successful emergency intubation is dependent on inter-related patient and operator factors. Preoxygenation has been used to maximise oxygen reserves in the patient and to prolong the safe apnoeic time during the intubation phase. Transnasal Humidified Rapid Insufflation Ventilatory Exchange (THRIVE) prolongs the safe apnoeic window for a safe intubation during elective intubation. We designed a clinical trial to test the hypothesis that THRIVE reduces the frequency of adverse and hypoxemic events during emergency intubation in children and to test the hypothesis that this treatment is cost-effective compared with standard care. The Kids THRIVE trial is a multicentre randomised controlled trial performed in participating emergency departments and paediatric intensive care units. 960 infants and children aged 0-16 years requiring emergency intubation for all reasons will be enrolled and allocated to THRIVE or control in a 1:1 allocation with stratification by site, age (<1, 1-7 and >7 years) and operator (junior and senior). Children allocated to THRIVE will receive weight appropriate transnasal flow rates with 100% oxygen, whereas children in the control arm will not receive any transnasal oxygen insufflation. The primary outcomes are defined as follows: (1) hypoxemic event during the intubation phase defined as SpO Ethics approval for the protocol and consent process has been obtained (HREC/16/QRCH/81). The trial has been actively recruiting since May 2017. The study findings will be submitted for publication in a peer-reviewed journal. ACTRN12617000147381.

Identifiants

DOI: 10.1136/bmjopen-2018-025997 PMID: 30787094 PMC: PMC6398737
pubmed: 30787094
pii: bmjopen-2018-025997
doi: 10.1136/bmjopen-2018-025997
pmc: PMC6398737
doi:

Substances chimiques

Carbon Dioxide 142M471B3J

Banques de données

ANZCTR
['ACTRN12617000147381']

Types de publication

Clinical Trial Protocol Journal Article Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

e025997

Investigateurs

Dr Philip Sargent (DP)
Gold Coast University Hospitaldr Christa Bell (GC)
Gold Coast University Hospital (GC)

Informations de copyright

© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Déclaration de conflit d'intérêts

Competing interests: SG, AS and SRD received travel support from Fisher and Paykel Healthcare.

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Auteurs

Shane George (S)

Children's Critical Care Service, Gold Coast University Hospital, Southport, Queensland, Australia.
School of Medicine, Griffith University, Southport, Queensland, Australia.
Paediatric Critical Care Research Group (PCCRG), Queensland Children's Hospital and The University of Queensland, Brisbane, Queensland, Australia.
Paediatric Research in Emergency Departments International Collaborative (PREDICT), Parkville, Victoria, Australia.
Paediatric Study Group, Australia and New Zealand Intensive Care Society (ANZICS PSG), Melbourne, Victoria, Australia.
ORCID: 0000-0002-8880-1245

Susan Humphreys (S)

Paediatric Critical Care Research Group (PCCRG), Queensland Children's Hospital and The University of Queensland, Brisbane, Queensland, Australia.

Tara Williams (T)

Paediatric Critical Care Research Group (PCCRG), Queensland Children's Hospital and The University of Queensland, Brisbane, Queensland, Australia.

Ben Gelbart (B)

Paediatric Intensive Care Unit, Royal Children's Hospital Melbourne, Parkville, Victoria, Australia.
Murdoch Children's Research Institute, Parkville, Victoria, Australia.

Arjun Chavan (A)

Paediatric Intensive Care Unit, The Townsville Hospital, Townsville, Queensland, Australia.

Katie Rasmussen (K)

Critical Care Division, Queensland Children's Hospital, Brisbane, Queensland, Australia.
Paediatric Emergency Research Unit, Centre for Children's Health Research, Children's Health Queensland, Brisbane, Queensland, Australia.

Anusha Ganeshalingham (A)

Starship Children's Hospital, Auckland, Auckland, New Zealand.

Simon Erickson (S)

Paediatric Critical Care, Perth Children's Hospital, Perth, Western Australia, Australia.

Subodh Suhas Ganu (SS)

Department of Paediatric Critical Care Medicine, Women's and Children's Hospital, North Adelaide, South Australia, Australia.

Nitesh Singhal (N)

Paediatric Intensive Care Unit, Royal Alexandra Hospital for Children, Westmead, New South Wales, Australia.

Kelly Foster (K)

Paediatric Research in Emergency Departments International Collaborative (PREDICT), Parkville, Victoria, Australia.
Paediatric Emergency Research Unit, Centre for Children's Health Research, Children's Health Queensland, Brisbane, Queensland, Australia.

Brenda Gannon (B)

Centre for the Business and Economics of Health, The University of Queensland, Brisbane, Queensland, Australia.

Kristen Gibbons (K)

Paediatric Critical Care Research Group (PCCRG), Queensland Children's Hospital and The University of Queensland, Brisbane, Queensland, Australia.

Luregn J Schlapbach (LJ)

Paediatric Critical Care Research Group (PCCRG), Queensland Children's Hospital and The University of Queensland, Brisbane, Queensland, Australia.
ORCID: 0000-0003-2281-2598

Marino Festa (M)

Paediatric Study Group, Australia and New Zealand Intensive Care Society (ANZICS PSG), Melbourne, Victoria, Australia.
Paediatric Intensive Care Unit, Royal Alexandra Hospital for Children, Westmead, New South Wales, Australia.

Stuart Dalziel (S)

Paediatric Research in Emergency Departments International Collaborative (PREDICT), Parkville, Victoria, Australia.
Starship Children's Hospital, Auckland, Auckland, New Zealand.
Department of Surgery, University of Auckland, Auckland, New Zealand.

Andreas Schibler (A)

Paediatric Critical Care Research Group (PCCRG), Queensland Children's Hospital and The University of Queensland, Brisbane, Queensland, Australia.
Paediatric Study Group, Australia and New Zealand Intensive Care Society (ANZICS PSG), Melbourne, Victoria, Australia.

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Classifications MeSH

questionsmedicales.fr › Thérapeutique › Traitement médicamenteux › Voies d'administration de substances chimiques et des médicaments › Administration par voie topique › Administration par voie muqueuse › Administration par voie nasale › Transnasal Humidified Rapid Insufflation...
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