scholarly journals Design and implementation of the AIRWAYS-2 trial: A multi-centre cluster randomised controlled 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

Resuscitation ◽  
2016 ◽  
Vol 109 ◽  
pp. 25-32 ◽  
Author(s):  
Jodi Taylor ◽  
Sarah Black ◽  
Stephen J. Brett ◽  
Kim Kirby ◽  
Jerry P. Nolan ◽  
...  
2021 ◽  
Vol 11 (1) ◽  
pp. 217
Author(s):  
Loric Stuby ◽  
Laurent Jampen ◽  
Julien Sierro ◽  
Maxime Bergeron ◽  
Erik Paus ◽  
...  

Early insertion of a supraglottic airway (SGA) device could improve chest compression fraction by allowing providers to perform continuous chest compressions or by shortening the interruptions needed to deliver ventilations. SGA devices do not require the same expertise as endotracheal intubation. This study aimed to determine whether the immediate insertion of an i-gel® while providing continuous chest compressions with asynchronous ventilations could generate higher CCFs than the standard 30:2 approach using a face-mask in a simulation of out-of-hospital cardiac arrest. A multicentre, parallel, randomised, superiority, simulation study was carried out. The primary outcome was the difference in CCF during the first two minutes of resuscitation. Overall and per-cycle CCF quality of compressions and ventilations parameters were also compared. Among thirteen teams of two participants, the early insertion of an i-gel® resulted in higher CCFs during the first two minutes (89.0% vs. 83.6%, p = 0.001). Overall and per-cycle CCF were consistently higher in the i-gel® group, even after the 30:2 alternation had been resumed. In the i-gel® group, ventilation parameters were enhanced, but compressions were significantly shallower (4.6 cm vs. 5.2 cm, p = 0.007). This latter issue must be addressed before clinical trials can be considered.


2020 ◽  
Vol 5 (1) ◽  
pp. 26-31
Author(s):  
Jonathan Green ◽  
Maria Robinson ◽  
Richard Pilbery ◽  
Gregory Whitley ◽  
Helen Hall ◽  
...  

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.


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