Protocol for a cluster randomised controlled feasibility study of Prehospital Optimal Shock Energy for Defibrillation (POSED)

•Evidence for best shock energy to treat out-of-hospital cardiac arrest is lacking.•POSED is a feasibility study for a future trial intended to close the evidence gap.•90 patients will be recruited within a single NHS Ambulance Service.•Feasibility will be tested by comparing numbers of eligible wit...

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Published in:	Resuscitation plus Vol. 12; p. 100310
Main Authors:	Pocock, Helen, Deakin, Charles D., Lall, Ranjit, Michelet, Felix, Contreras, Abraham, Ainsworth-Smith, Mark, King, Phil, Devrell, Anne, Smith, Debra E., Perkins, Gavin D.
Format:	Journal Article
Language:	English
Published:	Netherlands Elsevier B.V 01-12-2022 Elsevier
Subjects:	Cardiopulmonary Resuscitation Defibrillation Electric Countershock Feasibility study Out-of-Hospital Cardiac Arrest Protocol Paper Ventricular Fibrillation CONSORT CPR ROOR Electric Countershock PPI J ToF ILCOR CPMS RFA B-CPR OHCA SPIRIT ISRCTN POSED Out-of-Hospital Cardiac Arrest NIHR OR AE AOR WCTU ePR ICA SOC CAD ROSC SMG PEA mRS pVT VF Cardiopulmonary Resuscitation REC BTE Feasibility study JRCALC GCP CRF HRA Ventricular Fibrillation Defibrillation SMG, Study Management Group GCP, Good Clinical Practice B-CPR, Bystander CPR CRF, Case Report Form ROOR, Return of Organised Rhythm ToF, Termination of Fibrillation WCTU, Warwick Clinical Trials Unit CPR, Cardiopulmonary Resuscitation AE, Adverse Event AOR, Adjusted Odds Ratio PPI, Patient and Public Involvement NIHR, National Institute for Health and care Research PEA, Pulseless Electrical Activity ILCOR, International Liaison Committee on Resuscitation RFA, Rankin Focused Assessment SOC, Study Oversight Committee ROSC, Return of Spontaneous Circulation VF, Ventricular Fibrillation JRCALC, Joint Royal Colleges Ambulance Liaison Committee CAD, Computer Aided Despatch HRA, Health Research Authority OHCA, Out-of-Hospital Cardiac Arrest ICA, Integrated Clinical and practitioner Academic programme REC, Research Ethics Committee CONSORT, CONsolidated Standards Of Reporting Trials SPIRIT, Standard Protocol Items: Recommendations for Intervention Trials CPMS, Central Portfolio Management System ISRCTN, International Standard Registered Clinical/social sTudy Number J, Joules mRS, Modified Rankin Scale BTE, Biphasic Truncated Exponential waveform ePR, Electronic Patient Record OR, Odds Ratio POSED, Prehospital Optimal Shock Energy for Defibrillation pVT, Pulseless Ventricular Tachycardia
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Summary:	•Evidence for best shock energy to treat out-of-hospital cardiac arrest is lacking.•POSED is a feasibility study for a future trial intended to close the evidence gap.•90 patients will be recruited within a single NHS Ambulance Service.•Feasibility will be tested by comparing numbers of eligible with recruited patients.•We will select best outcomes for a trial based on clinical relevance, reliability and ease of recording. 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. 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) 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. The POSED study will assess the feasibility of a large-scale trial and explore opportunities to optimise the trial protocol. Trial registration: ISRCTN16327029.
Bibliography:	ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 23
ISSN:	2666-5204 2666-5204
DOI:	10.1016/j.resplu.2022.100310