Randomised trial of the clinical and cost effectiveness of a supraglottic airway device compared with tracheal intubation for in-hospital cardiac arrest (AIRWAYS-3): Protocol, design and implementation

Watkins, Scott; Chowdhury, Fatimah J.; Norman, Chloe; Brett, Stephen J.; Couper, Keith; Goodwin, Laura; Gould, Doug W.; AE. Harrison, David; Hossain, Anower; Lall, Ranjit; Mason, James; Nolan, Jerry P.; Nwankwo, Henry; Perkins, Gavin D.; Samuel, Katie; Schofield, Behnaz; Soar, Jasmeet; Starr, Kath; Thomas, Matthew; Voss, Sarah; Benger, Jonathan R.

Abstract

Survival from in-hospital cardiac arrest is approximately 18%, but for patients who require advanced airway management survival is lower. Those who do survive are often left with significant disability. Traditionally, resuscitation of cardiac arrest patients has included tracheal intubation, however insertion of a supraglottic airway has gained popularity as an alternative approach to advanced airway management. Evidence from out-of-hospital cardiac arrest suggests no significant differences in mortality or morbidity between these two approaches, but there is no randomised evidence for airway management during in-hospital cardiac arrest. The aim of the AIRWAYS-3 randomised trial, described in this protocol paper, is to determine the clinical and cost effectiveness of a supraglottic airway versus tracheal intubation during in-hospital cardiac arrest. Patients will be allocated randomly to receive either a supraglottic airway or tracheal intubation as the initial advanced airway management. We will also estimate the relative cost-effectiveness of these two approaches. The primary outcome is functional status, measured using the modified Rankin Scale at hospital discharge or 30 days post-randomisation, whichever occurs first. AIRWAYS-3 presents ethical challenges regarding patient consent and data collection. These include the enrolment of unconscious patients without prior consent in a way that avoids methodological bias. Other complexities include the requirement to randomise patients efficiently during a time-critical cardiac arrest. Many of these challenges are encountered in other emergency care research; we discuss our approaches to addressing them. Trial registration: ISRCTN17720457. Prospectively registered on 29/07/2022.

• Journal Article Type: Article
• Acceptance Date: Jul 3, 2023
• Online Publication Date: Jul 18, 2023
• Publication Date: Sep 30, 2023
• Deposit Date: Jul 19, 2023
• Publicly Available Date: Jul 21, 2023
• Journal: Resuscitation Plus
• Electronic ISSN: 2666-5204
• Publisher: Elsevier
• Peer Reviewed: Peer Reviewed
• Volume: 15
• Article Number: 100430
• DOI: https://doi.org/10.1016/j.resplu.2023.100430
• Keywords: Cardiology and Cardiovascular Medicine; Emergency Nursing; Emergency Medicine
• Public URL: https://uwe-repository.worktribe.com/output/10958147
• Additional Information: This article is maintained by: Elsevier; Article Title: Randomised trial of the clinical and cost effectiveness of a supraglottic airway device compared with tracheal intubation for in-hospital cardiac arrest (AIRWAYS-3): Protocol, design and implementation; Journal Title: Resuscitation Plus; CrossRef DOI link to publisher maintained version: https://doi.org/10.1016/j.resplu.2023.100430; Content Type: article; Copyright: © 2023 The Author(s). Published by Elsevier B.V.