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BMJ Open. 2019 Feb 20;9(2):e025997. doi: 10.1136/bmjopen-2018-025997.

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

Author information

1
Children's Critical Care Service, Gold Coast University Hospital, Southport, Queensland, Australia.
2
School of Medicine, Griffith University, Southport, Queensland, Australia.
3
Paediatric Critical Care Research Group (PCCRG), Queensland Children's Hospital and The University of Queensland, Brisbane, Queensland, Australia.
4
Paediatric Research in Emergency Departments International Collaborative (PREDICT), Parkville, Victoria, Australia.
5
Paediatric Study Group, Australia and New Zealand Intensive Care Society (ANZICS PSG), Melbourne, Victoria, Australia.
6
Paediatric Intensive Care Unit, Royal Children's Hospital Melbourne, Parkville, Victoria, Australia.
7
Murdoch Children's Research Institute, Parkville, Victoria, Australia.
8
Paediatric Intensive Care Unit, The Townsville Hospital, Townsville, Queensland, Australia.
9
Critical Care Division, Queensland Children's Hospital, Brisbane, Queensland, Australia.
10
Paediatric Emergency Research Unit, Centre for Children's Health Research, Children's Health Queensland, Brisbane, Queensland, Australia.
11
Starship Children's Hospital, Auckland, Auckland, New Zealand.
12
Paediatric Critical Care, Perth Children's Hospital, Perth, Western Australia, Australia.
13
Department of Paediatric Critical Care Medicine, Women's and Children's Hospital, North Adelaide, South Australia, Australia.
14
Paediatric Intensive Care Unit, Royal Alexandra Hospital for Children, Westmead, New South Wales, Australia.
15
Centre for the Business and Economics of Health, The University of Queensland, Brisbane, Queensland, Australia.
16
Department of Surgery, University of Auckland, Auckland, New Zealand.

Abstract

INTRODUCTION:

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.

METHODS AND ANALYSIS:

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 SpO2 <90% (patient-dependent variable) and (2) first intubation attempt success without hypoxemia (operator-dependent variable). Analyses will be conducted on an intention-to-treat basis.

ETHICS AND DISSEMINATION:

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.

TRIAL REGISTRATION NUMBER:

ACTRN12617000147381.

KEYWORDS:

airway management; apnoeic oxygenation; intubation; nasal high-flow; paediatrics; transnasal humidified rapid insufflation ventilatory exchange

PMID:
30787094
DOI:
10.1136/bmjopen-2018-025997
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Conflict of interest statement

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

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