AIRWAYS-3
Research type
Research Study
Full title
Randomised trial of the clinical and cost effectiveness of a supraglottic airway device versus intubation during in-hospital cardiac arrest
IRAS ID
314379
Contact name
Jonathan Benger
Contact email
Sponsor organisation
University Hospitals Bristol and Weston NHS Foundation Trust
ISRCTN Number
ISRCTN17720457
Duration of Study in the UK
3 years, 11 months, 31 days
Research summary
This is a multi-centre, open-label, pragmatic, individually randomised, parallel group, superiority trial and economic evaluation to determine the clinical and cost effectiveness of a supraglottic airway (SGA) device versus tracheal intubation (TI) during in-hospital cardiac arrest (IHCA). IHCA is a sudden, unpredictable and life-threatening event that affects approximately 1 in 1,000 hospital inpatients, and for which the current survival rate is low. There is clinical equipoise and wide variation in practice regarding the best approach to advanced airway management during IHCA, though some international observational evidence favouring alternatives to TI.
The trial will be conducted in the acute setting in over 100 NHS hospitals throughout the UK. Adult patients who suffer IHCA and require advanced airway management will be randomised by the attending cardiac arrest team to receive either SGA or TI in a 1:1 ratio. We have developed and tested bespoke processes to ensure that study procedures do not delay or interfere with the delivery of life-saving treatments.
An internal pilot study will confirm the feasibility of the trial. An integrated economic evaluation will assess the cost-effectiveness of SGA compared with TI. We are working closely with the relevant clinical teams to ensure the trial can be delivered successfully, and require a total of 4190 participants (2095 in each group) to demonstrate a 3% difference in our primary outcome of the Modified Rankin Scale (mRS) score assessed at hospital discharge or 30 days following IHCA, whichever occurs sooner.
The Modified Rankin Scale is well established as a patient-focussed outcome in cardiac arrest. We will also collect mortality and a range of secondary and safety outcomes, up to six months post IHCA, to assess recovery and the cost effectiveness of the two treatment options. Patient and public involvement has been integral to the design of the study, and this application, and our PPI representatives continue to be fully involved in the delivery, interpretation and dissemination of AIRWAYS-3.REC name
Wales REC 1
REC reference
22/WA/0156
Date of REC Opinion
22 Jul 2022
REC opinion
Further Information Favourable Opinion