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Amendments

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 SGA versus TI during IHCA. The trial will be conducted in the acute setting in NHS hospitals throughout the UK.

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.

Trial 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 in-hospital cardiac arrest, 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

Trial Outcomes

Primary

Functional status at hospital discharge (or 30 days post-randomisation whichever is shorter) as measured by the modified Rankin Scale (mRS)

Secondary

  • Initial ventilation success
  • Regurgitation/aspiration during resuscitation
  • Return of Spontaneous circulation (ROSC) >20 minutes
  • ICU and hospital length of stay
  • Health-related quality of life at discharge, 3 and 6 months)
  • Survival to hospital discharge, 3 months and 6 months
  • Functional status (mRS) at 3 and 6 months

Eligibility Criteria:

Inclusion Criteria
Exclusion Criteria
  • Adult (known or believed to be age >=18)
  • In-hospital cardiac arrest, attended by the hospital cardiac arrest team in response to a cardiac arrest call (2222 or equivalent), and including a clinician permitted to undertake tracheal intubation and supraglottic airway placement so that either intervention can be delivered
  • Undergoing resuscitation and requiring advanced airway management in the opinion of the clinician managing the patient’s airway
  • Patients in the emergency department
  • People who are not a hospital inpatient (e.g. visitor, relative, staff or outpatient)
  • Patients already receiving advanced airway management (including a supraglottic airway device) at the time of eligibility assessment
  • Patients known to be pregnant
  • Patients with a functioning tracheostomy

Airways3

Contact Trial Team

Email:

airways3@warwick.ac.uk

Address:

AIRWAYS-3 Trial Manager,
Warwick Clinical Trials Unit,
Warwick Medical School,
University of Warwick,
Coventry.
CV4 7AL

CTU Trial Team Members

Trial Manager - Chloe Norman

Trial Co-ordinator - Loraine Chowdhury

Trial Co-ordinator - Jannat Chowdhury

Data Entry Clerk - Laurilee Sprauve

NIHR

Bristol Hospitals

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