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Protocol for a cluster randomised controlled feasibility study of Prehospital Optimal Shock Energy for Defibrillation (POSED)
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Pocock, Helen, Deakin, Charles D., Lall, Ranjit, Michelet, Felix, Contreras, Abraham, Ainsworth-Smith, Mark, King, Phil, Devrell, Anne, Smith, Debra and Perkins, Gavin D. (2022) Protocol for a cluster randomised controlled feasibility study of Prehospital Optimal Shock Energy for Defibrillation (POSED). Resuscitation Plus, 12 . 100310. doi:10.1016/j.resplu.2022.100310 ISSN 2666-5204.
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WRAP-Protocol-for-a-cluster-randomised-controlled-feasibility-study-of-Prehospital-Optimal-Shock-Energy-for-Defibrillation-POSED-Pocock-2022.pdf - Published Version - Requires a PDF viewer. Available under License Creative Commons Attribution 4.0. Download (1156Kb) | Preview |
Official URL: https://doi.org/10.1016/j.resplu.2022.100310
Abstract
Aims: The Prehospital Optimal Shock Energy for Defibrillation (POSED) study will assess the feasibility of conducting a cluster randomised controlled study of clinical effectiveness in UK ambulance services to identify the optimal shock energy for defibrillation.
Methods: POSED is a pragmatic, allocation concealed, open label, cluster randomised, controlled feasibility study. Defibrillators within a single UK
ambulance service will be randomised in an equal ratio to deliver one of three shock strategies 120–150–200 J, 150–200–200 J, 200–200–200 J.
Consecutive adults (18 years or over) presenting with out of hospital cardiac arrest requiring defibrillation will be eligible. The study plans to enrol 90 patients (30 in each group). Patients (or their relatives for non-survivors) will be informed about trial participation after the initial emergency has resolved. Survivors will be invited to consent to participate in follow-up (i.e., at 30 days or discharge).
The primary feasibility outcome is the proportion of eligible patients who receive the randomised study intervention. Secondary feasibility outcomes will include recruitment rate, adherence to allocated treatment and data completeness. Clinical outcomes will include Return of an Organised Rhythm (ROOR) at 2 minutes post-shock, refibrillation rate, Return of Spontaneous Circulation (ROSC) at hospital handover, survival and neurological outcome at 30 days.
Conclusion: The POSED study will assess the feasibility of a large-scale trial and explore opportunities to optimise the trial protocol.
Item Type: | Journal Article | ||||||||
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Subjects: | R Medicine > R Medicine (General) R Medicine > RC Internal medicine R Medicine > RM Therapeutics. Pharmacology |
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Divisions: | Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School > Clinical Trials Unit Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School |
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Library of Congress Subject Headings (LCSH): | Defibrillators , Cardiac arrest , Ventricular fibrillation , Electric countershock , CPR (First aid) | ||||||||
Journal or Publication Title: | Resuscitation Plus | ||||||||
Publisher: | Elsevier | ||||||||
ISSN: | 2666-5204 | ||||||||
Official Date: | December 2022 | ||||||||
Dates: |
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Volume: | 12 | ||||||||
Number of Pages: | 17 | ||||||||
Article Number: | 100310 | ||||||||
DOI: | 10.1016/j.resplu.2022.100310 | ||||||||
Status: | Peer Reviewed | ||||||||
Publication Status: | Published | ||||||||
Access rights to Published version: | Open Access (Creative Commons) | ||||||||
Date of first compliant deposit: | 12 October 2022 | ||||||||
Date of first compliant Open Access: | 13 October 2022 | ||||||||
RIOXX Funder/Project Grant: |
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