Design and implementation of the AIRWAYS-2 trial: A multi-centre cluster randomised controlled trial of the clinical and cost effectiveness of the i-gel supraglottic airway device versus tracheal intubation in the initial airway management of out of hospital cardiac arrest. (December 2016)

• Record Type: Journal Article
• Authors: Taylor, Jodi; Black, Sarah; J. Brett, Stephen; Kirby, Kim; Nolan, Jerry P.; Reeves, Barnaby C.; Robinson, Maria; Rogers, Chris A.; Scott, Lauren J.; South, Adrian; Stokes, Elizabeth A.; Thomas, Matthew; Voss, Sarah; Wordsworth, Sarah; Benger, Jonathan R.
• Is Part Of: Resuscitation. Volume 109(2016)
• Page Start: 25
• Page End: 32
• Publication Date: 2016-12
• Subjects: Cardiac arrest -- Emergency medical services -- Tracheal intubation -- Supraglottic airway device -- Randomised clinical trial; CAD computer aided dispatch -- CAG Confidentiality Advisory Group -- CPR cardiopulmonary resuscitation -- CRF case report form -- CTEU Clinical Trials and Evaluation Unit -- EEAST East of England Ambulance Service NHS Trust -- EMAS East Midlands Ambulance Service NHS Trust -- EMS Emergency Medical Services -- HES Hospital Episode Statistics -- ICC intraclass correlation -- ILCOR International Liaison Committee on Resuscitation -- JRCALC Joint Royal Colleges Ambulance Liaison Committee -- mRS modified Rankin Scale -- NICE National Institute for Health and Care Excellence -- NHS UK National Health Service -- OHCA out of hospital cardiac arrest -- QALY quality adjusted life year -- RCT randomised controlled trial -- ROSC return of spontaneous circulation -- SADE serious adverse device event -- SAE serious adverse event -- SGA supraglottic airway -- SWAST South Western Ambulance Service NHS Foundation Trust -- UK United Kingdom -- YAS Yorkshire Ambulance Service NHS Trust; Resuscitation -- Periodicals; Resuscitation -- Periodicals; Réanimation -- Périodiques; Electronic journals; 616.025
• DOI: 10.1016/j.resuscitation.2016.09.016
• Languages: English
• ISSNs: 0300-9572

Abstract

Abstract: Health outcomes after out of hospital cardiac arrest (OHCA) are extremely poor, with only 7–9% of patients in the United Kingdom (UK) surviving to hospital discharge. Currently emergency medical services (EMS) use either tracheal intubation or newer supraglottic airway devices (SGAs) to provide advanced airway management during OHCA. Equipoise between the two techniques has led to calls for a well-designed randomised controlled trial. The primary objective of the AIRWAYS-2 trial is to assess whether the clinical effectiveness of the i-gel, a second-generation SGA, is superior to tracheal intubation in the initial airway management of OHCA patients in the UK. Paramedics recruited to the AIRWAYS-2 trial are randomised to use either tracheal intubation or i-gel as their first advanced airway intervention. Adults who have had a non-traumatic OHCA and are attended by an AIRWAYS-2 paramedic are retrospectively assessed against eligibility criteria for inclusion. The primary outcome is the modified Rankin Scale score at hospital discharge. Secondary objectives are to: (i) estimate differences between groups in outcome measures relating to airway management, hospital stay and recovery at 3 and 6 months; (ii) estimate the cost effectiveness of the i-gel compared to tracheal intubation. Because OHCA patient needs immediate treatment there are several unusual features and challenges to the design and implementation of this trial; these include level of randomisation, the automatic enrolment model, enrolment of patients that lack capacity and minimisation of bias. Patient enrolment began in June 2015. The trial will enrol 9070 patients over two years. The results are expected to influence future resuscitation guidelines. Trial Registration ISRCTN : 08256118.