Abstract
Introduction: AIRWAYS-2 was a cluster randomised controlled trial (RCT) comparing the clinical and cost effectiveness of the i-gel supraglottic airway device with tracheal intubation in the initial airway management of out-of-hospital cardiac arrest (OHCA). In order to successfully conduct this clinical trial, it was necessary for research paramedics to overcome multiple challenges, many of which will be relevant to future emergency medical service (EMS) research. This article aims to describe a number of the challenges that were encountered during the out-of-hospital phase of the AIRWAYS-2 trial and how these were overcome.Methods: The research paramedics responsible for conducting the pre-hospital phase of the trial were asked to reflect on their experience of facilitating the AIRWAYS-2 trial. Responses were then collated by the lead author. A process of iterative revision and review was undertaken by the research paramedics to produce a consensus of opinion.Results: The main challenges identified by the trial research paramedics related to the recruitment and training of paramedics, screening of eligible patients and investigation of protocol deviations / reporting errors. Even though a feasibility study was conducted prior to the commencement of AIRWAYS-2, the scale of these challenges was underestimated.Conclusion: Large-scale pragmatic cluster randomised trials are being successfully undertaken in out-of-hospital care. However, they require intensive engagement with EMS clinicians and local research paramedics, particularly when the intervention is contentious. Feasibility studies are an important part of research but may fail to identify all potential challenges. Therefore, flexibility is required to manage unforeseen difficulties.
DOI
10.29045/14784726.2020.06.5.1.26
Publication Date
2020-06-01
Publication Title
British Paramedic Journal
Volume
5
Issue
1
First Page
26
Last Page
31
ISSN
1478-4726
Embargo Period
2021-06-01
Organisational Unit
School of Health Professions
Recommended Citation
Green, J., Robinson, M., Pilbery, R., Whitley, G., Hall, H., Clout, M., Reeves, B., Kirby, K., & Benger, J. (2020) 'Research paramedics’ observations regarding the challenges and strategies employed in the implementation of a large-scale out-of-hospital randomised trial', British Paramedic Journal, 5(1), pp. 26-31. Available at: https://doi.org/10.29045/14784726.2020.06.5.1.26
