Design and implementation of a large and complex trial in emergency medical services.

ABSTRACT:

Background

The research study titled "Cluster randomised 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 (AIRWAYS-2)" is a large-scale study being run in the English emergency medical (ambulance) services (EMS). It compares two airway management strategies (tracheal intubation and the i-gel) in out-of-hospital cardiac arrest. We describe the methods used to minimise bias and the challenges associated with the set-up, enrolment, and follow-up that were addressed.

Methods

AIRWAYS-2 enrols adults without capacity when there is no opportunity to seek prior consent and when the intervention must be delivered immediately. We therefore adopted a cluster

SUBMITTER: Robinson MJ 

PROVIDER: S-EPMC6368693 | biostudies-literature | 2019 Feb

REPOSITORIES: biostudies-literature