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

George, Shane and Humphreys, Susan and Williams, Tara and Gelbart, Ben and Chavan, Arjun and Rasmussen, Katie and Ganeshalingham, Anusha and Erickson, Simon and Ganu, Subodh Suhas and Singhal, Nitesh and Foster, Kelly ORCID: https://orcid.org/0000-0002-3328-2177 and Gannon, Brenda and Gibbons, Kristen and Schlapbach, Luregn and Festa, Marino and Dalziel, Stuart and Schibler, Andreas (2019) Transnasal Humidified Rapid Insufflation Ventilatory Exchange in children requiring emergent intubation (Kids THRIVE): a protocol for a randomised controlled trial. BMJ Open, 9 (2). pp. 1-8.

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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.


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Item Type: Article (Commonwealth Reporting Category C)
Refereed: Yes
Item Status: Live Archive
Additional Information: This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license
Faculty/School / Institute/Centre: Current - Faculty of Health, Engineering and Sciences - School of Nursing and Midwifery (1 Jan 2015 -)
Faculty/School / Institute/Centre: Current - Faculty of Health, Engineering and Sciences - School of Nursing and Midwifery (1 Jan 2015 -)
Date Deposited: 15 Jan 2020 05:35
Last Modified: 10 Mar 2020 03:13
Uncontrolled Keywords: adolescent, child clinical, controlled study, emergency ward, human hypoxemia, infant intubation, multicenter study, newborn outcome assessment, pediatric intensive care, unitrandomized, controlled trial respiratory, air flow transnasal humidified, rapid insufflation, ventilatory exchange
Fields of Research (2008): 11 Medical and Health Sciences > 1114 Paediatrics and Reproductive Medicine > 111403 Paediatrics
Socio-Economic Objectives (2008): C Society > 92 Health > 9299 Other Health > 929999 Health not elsewhere classified
Funding Details:
Identification Number or DOI: https://doi.org/10.1136/bmjopen-2018-025997
URI: http://eprints.usq.edu.au/id/eprint/36219

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