Randomised trial of the clinical and cost effectiveness of a supraglottic airway device versus tracheal intubation during in-hospital cardiac arrest (AIRWAYS-3)

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?

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.

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.

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.

METHODS: Setting: NHS acute hospitals across the United Kingdom. Randomisation: Allocation concealed, randomisation (1:1) stratified by hospital and time of day (day/night).

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. Health technologies being assessed: Supraglottic airway device versus tracheal intubation. Primary outcome: Modified Rankin Scale (mRS) score assessed at hospital discharge.

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).

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.

Sample size: 4,190 participants (90% power, 5% alpha, to detect a 3% absolute difference in ‘better’ mRS dichotomized categorization).

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).

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.