Title: Randomised trial of the clinical and cost effectiveness of a supraglottic airway device versus tracheal intubation during in-hospital cardiac arrest (AIRWAYS-3)
Funder: Department of Health and Social Care

Abstract: AIM: _x000D_ To find out whether insertion of a new type of airway device to restore breathing is more effective than the traditional technique of tracheal intubation for adults who have a cardiac arrest while in hospital._x000D_ _x000D_ BACKGROUND: _x000D_ Cardiac arrest occurs when the heart stops beating; it is an extreme medical emergency. If a patient in hospital has a cardiac arrest, their chance of surviving to leave hospital is less than one in four. Immediate chest compressions combined with rescue breathing improve the chances of survival. _x000D_ _x000D_ We do not know the best way for hospital staff to provide rescue breathing (airway management) during an in-hospital cardiac arrest. Traditionally, placing a breathing tube in the windpipe (tracheal intubation) has been considered the best method. However, inserting the tube requires specialist skills. A newer alternative is a supraglottic airway device, placed in the throat just above the voice box. Such devices are easier and quicker to use and require less training. However, they may protect the lungs less from damage by vomit and may not be as good at inflating the lungs. The International Liaison Committee on Resuscitation has highlighted an urgent need for research in this area._x000D_ _x000D_ DESIGN AND METHODS:_x000D_ A total of 4,190 patients (from 120 hospitals) will be allocated to one of these two types of airway management in a process called randomisation. We will compare the degree of disability, survival rates, quality of life, use of NHS resources (e.g. hospital bed days and procedures) for all patients included in the trial. The research will cover each patient’s hospital stay and 3 and 6 months after the cardiac arrest. Information will be collected primarily from hospital databases, to reduce the amount that patients need to do. It will be collected using postal questionnaires and routine data with the patient’s consent. Treatment costs will be measured for each approach. Initially, a smaller study of 420 patients (from 40 hospitals) will be done to test the procedures for the larger trial. _x000D_ _x000D_ PATIENT AND PUBLIC INVOLVEMENT: _x000D_ We have an established patient and public research advisory group that was central to a previous similar study. This group and others with experience of cardiac arrest have contributed to the design of this research, and their involvement will be key in completing the trial successfully. Our patient and public contributors have advised on design, consent, data collection and the outcomes measured. They will also assist in disseminating the study’s results. Two members of the group will join the independent trial steering committee, and regular reports will be provided to all our patient and public contributors, seeking the benefit of their experience and advice as the research proceeds._x000D_ _x000D_ DISSEMINATION: _x000D_ Our plan includes sharing the results with patients, public, healthcare professionals, service managers and academic experts internationally. We will present the research at medical conferences and through social media, podcasts, infographics, written reports and scientific publications. We will work closely with professional organizations to ensure that the findings contribute to future NHS and international resuscitation guidelines. We anticipate that this will improve the outcome for future patients who suffer an in-hospital cardiac arrest.

Lay abstract: RESEARCH QUESTION: In adults with in-hospital cardiac arrest (IHCA) does the use of a supraglottic airway (SGA), compared with tracheal intubation (TI), improve survival with a favourable functional outcome at hospital discharge?_x000D_ _x000D_ BACKGROUND: The incidence of IHCA is 1 per 1,000 hospital admissions. Treatment of IHCA patients is resource intensive and the outcomes are poor; 24% survive to hospital discharge. TI skills are confined to relatively few individuals, compared to SGA; therefore, this research has important implications for the future composition and function of IHCA response teams as well as patient outcomes._x000D_ _x000D_ AIM: To conduct a multi-centre, open-label, pragmatic, individually randomised, parallel group, superiority trial and economic evaluation to determine the clinical and cost effectiveness of SGA versus TI during IHCA. An internal pilot will confirm feasibility._x000D_ _x000D_ OBJECTIVES: (1) Conduct an internal pilot study to confirm the feasibility of the large-scale multi-centre trial (2) Determine the clinical effectiveness of SGA management, for adults with IHCA, in terms of survival with a favourable functional outcome and health-related quality of life. (3) Estimate, in an integrated economic evaluation, the cost-effectiveness of SGA compared with TI._x000D_ _x000D_ METHODS:_x000D_ Setting: NHS acute hospitals across the United Kingdom._x000D_ _x000D_ Randomisation: Allocation concealed, randomisation (1:1) stratified by hospital and time of day (day/night)._x000D_ _x000D_ Eligibility: Inclusion criteria: Adults (age >18) with in-hospital cardiac arrest, for whom a cardiac arrest (2222) call is made and who undergo resuscitation requiring advanced airway management._x000D_ _x000D_ Health technologies being assessed: Supraglottic airway device versus tracheal intubation._x000D_ _x000D_ Primary outcome: Modified Rankin Scale (mRS) score assessed at hospital discharge._x000D_ _x000D_ Secondary outcomes: Initial ventilation success; regurgitation/aspiration during resuscitation; return of spontaneous circulation (ROSC); ICU and hospital stay. Follow-up: survival; functional (mRS) score and quality of life (3 and 6 months); additional unscheduled care and re-admissions (to 6 months)._x000D_ _x000D_ Economic outcomes: Incremental cost per quality-adjusted life year gained from the perspective of the NHS and personal social services. Within-trial and life-time model estimates will be generated._x000D_ _x000D_ Sample size: 4,190 participants (90% power, 5% alpha, to detect a 3% absolute difference in ‘better’ mRS dichotomized categorization)._x000D_ _x000D_ TIMELINE: 48 months in total: set-up (9 months); internal pilot (6 months); recruitment (18 months); final follow-up and analysis (9 months); reporting and dissemination (6 months)._x000D_ _x000D_ IMPACT AND DISSEMINATION: This study will provide definitive evidence regarding the most effective approach to advanced airway management for IHCA patients. The findings will inform future NHS and international practice. We will publish lay and professional summaries in written, audible and infographic styles. We will promote the findings at public engagement events and develop an informative, patient facing website with associated materials. We will disseminate to clinicians through peer-reviewed publications, podcasts, blogs, conference presentations and social media. We will engage policy makers through our membership of key organizations. The clinically relevant difference sought in AIRWAYS-3 equates to more than 400 additional survivors in the UK annually, and is strongly supported by our PPI group.

Research activity codes: 6.3 MEDICAL DEVICES
Health categories: CARDIOVASCULAR