Prehospital optimal shock energy for defibrillation (POSED): A cluster randomised controlled feasibility trial

Background: We explored the feasibility of a large-scale UK ambulance services trial of optimal defibrillation shock energy for out-of-hospital cardiac arrest. The primary objective of this feasibility study was to establish the number of eligible patients and the number recruited. Secondary outcome...

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Main Authors: Helen Pocock, Charles D Deakin, Ranjit Lall, Felix Michelet, Chu Sun, Deb Smith, Catherine Hill, Jeskaran Rai, Kath Starr, Martina Brown, Isabel Rodriguez-Bachiller, Gavin D. Perkins
Format: Article
Language:English
Published: Elsevier 2024-03-01
Series:Resuscitation Plus
Subjects:
Online Access:http://www.sciencedirect.com/science/article/pii/S2666520424000201
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author Helen Pocock
Charles D Deakin
Ranjit Lall
Felix Michelet
Chu Sun
Deb Smith
Catherine Hill
Jeskaran Rai
Kath Starr
Martina Brown
Isabel Rodriguez-Bachiller
Gavin D. Perkins
author_facet Helen Pocock
Charles D Deakin
Ranjit Lall
Felix Michelet
Chu Sun
Deb Smith
Catherine Hill
Jeskaran Rai
Kath Starr
Martina Brown
Isabel Rodriguez-Bachiller
Gavin D. Perkins
author_sort Helen Pocock
collection DOAJ
description Background: We explored the feasibility of a large-scale UK ambulance services trial of optimal defibrillation shock energy for out-of-hospital cardiac arrest. The primary objective of this feasibility study was to establish the number of eligible patients and the number recruited. Secondary outcomes were adherence to allocated treatment and data completeness. Methods: We conducted a three-arm parallel group cluster randomised controlled feasibility study in a single ambulance service in southern England. Adult patients in out-of-hospital cardiac arrest treated for a shockable rhythm were included. Zoll X series defibrillators (clusters) were randomised to deliver 120–150–200 J, 150–200–200 J, or 200–200–200 J shock strategies. Results: Between March 2022 and February 2023, we randomised 38 eligible patients (120–150–200 J (n = 12), 150–200–200 J (n = 10), 200–200–200 J (n = 16)) to the study. The recruitment rate per cluster was 0.07 per month. The median patient age was 71 years (IQR 59–81 years); 79% were male. Twenty-eight cardiac arrests (74%) occurred in a private residence, 29 (76%) were witnessed and 32 (84%) patients received bystander CPR. Treatment adherence was 93% and completeness of clinical and electrical outcomes was 86%. At 30 days, 3/36 (8.3%) patients survived; we were unable to collect survival outcomes for two patients. Defibrillation data collection became difficult when defibrillators became separated from their allocated vehicles. Conclusion: We have demonstrated the feasibility of a cluster randomised controlled trial of optimal shock energy for defibrillation in a UK ambulance service. We have identified possible solutions to issues relating to trial design.
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spelling doaj.art-1687646b8d584b819f692f6fe574d1a62024-03-27T04:53:07ZengElsevierResuscitation Plus2666-52042024-03-0117100569Prehospital optimal shock energy for defibrillation (POSED): A cluster randomised controlled feasibility trialHelen Pocock0Charles D Deakin1Ranjit Lall2Felix Michelet3Chu Sun4Deb Smith5Catherine Hill6Jeskaran Rai7Kath Starr8Martina Brown9Isabel Rodriguez-Bachiller10Gavin D. Perkins11South Central Ambulance NHS Foundation Trust, Talisman Way, Bicester, Oxfordshire OX26 6HR, UK; Warwick Clinical Trials Unit, University of Warwick, Gibbet Hill Road, Coventry, CV4 7AL, Warwickshire, UK; Corresponding author at: Warwick Clinical Trials Unit, University of Warwick, Gibbet Hill Road, Coventry CV4 7AL, UK.South Central Ambulance NHS Foundation Trust, Talisman Way, Bicester, Oxfordshire OX26 6HR, UK; University Hospitals Southampton NHS Foundation Trust, Tremona Road, Southampton, Hampshire, UKWarwick Clinical Trials Unit, University of Warwick, Gibbet Hill Road, Coventry, CV4 7AL, Warwickshire, UKWarwick Clinical Trials Unit, University of Warwick, Gibbet Hill Road, Coventry, CV4 7AL, Warwickshire, UKWarwick Clinical Trials Unit, University of Warwick, Gibbet Hill Road, Coventry, CV4 7AL, Warwickshire, UKWarwick Clinical Trials Unit, University of Warwick, Gibbet Hill Road, Coventry, CV4 7AL, Warwickshire, UKWarwick Clinical Trials Unit, University of Warwick, Gibbet Hill Road, Coventry, CV4 7AL, Warwickshire, UKWarwick Clinical Trials Unit, University of Warwick, Gibbet Hill Road, Coventry, CV4 7AL, Warwickshire, UKWarwick Clinical Trials Unit, University of Warwick, Gibbet Hill Road, Coventry, CV4 7AL, Warwickshire, UKSouth Central Ambulance NHS Foundation Trust, Talisman Way, Bicester, Oxfordshire OX26 6HR, UKSouth Central Ambulance NHS Foundation Trust, Talisman Way, Bicester, Oxfordshire OX26 6HR, UKWarwick Clinical Trials Unit, University of Warwick, Gibbet Hill Road, Coventry, CV4 7AL, Warwickshire, UK; University Hospitals Birmingham NHS Foundation Trust, Mindelsohn Way, Edgbaston, Birmingham B15 2GW, Warwickshire, UKBackground: We explored the feasibility of a large-scale UK ambulance services trial of optimal defibrillation shock energy for out-of-hospital cardiac arrest. The primary objective of this feasibility study was to establish the number of eligible patients and the number recruited. Secondary outcomes were adherence to allocated treatment and data completeness. Methods: We conducted a three-arm parallel group cluster randomised controlled feasibility study in a single ambulance service in southern England. Adult patients in out-of-hospital cardiac arrest treated for a shockable rhythm were included. Zoll X series defibrillators (clusters) were randomised to deliver 120–150–200 J, 150–200–200 J, or 200–200–200 J shock strategies. Results: Between March 2022 and February 2023, we randomised 38 eligible patients (120–150–200 J (n = 12), 150–200–200 J (n = 10), 200–200–200 J (n = 16)) to the study. The recruitment rate per cluster was 0.07 per month. The median patient age was 71 years (IQR 59–81 years); 79% were male. Twenty-eight cardiac arrests (74%) occurred in a private residence, 29 (76%) were witnessed and 32 (84%) patients received bystander CPR. Treatment adherence was 93% and completeness of clinical and electrical outcomes was 86%. At 30 days, 3/36 (8.3%) patients survived; we were unable to collect survival outcomes for two patients. Defibrillation data collection became difficult when defibrillators became separated from their allocated vehicles. Conclusion: We have demonstrated the feasibility of a cluster randomised controlled trial of optimal shock energy for defibrillation in a UK ambulance service. We have identified possible solutions to issues relating to trial design.http://www.sciencedirect.com/science/article/pii/S2666520424000201DefibrillationOut-of-hospital Cardiac ArrestVentricular FibrillationElectric CountershockCardiopulmonary ResuscitationFeasibility study
spellingShingle Helen Pocock
Charles D Deakin
Ranjit Lall
Felix Michelet
Chu Sun
Deb Smith
Catherine Hill
Jeskaran Rai
Kath Starr
Martina Brown
Isabel Rodriguez-Bachiller
Gavin D. Perkins
Prehospital optimal shock energy for defibrillation (POSED): A cluster randomised controlled feasibility trial
Resuscitation Plus
Defibrillation
Out-of-hospital Cardiac Arrest
Ventricular Fibrillation
Electric Countershock
Cardiopulmonary Resuscitation
Feasibility study
title Prehospital optimal shock energy for defibrillation (POSED): A cluster randomised controlled feasibility trial
title_full Prehospital optimal shock energy for defibrillation (POSED): A cluster randomised controlled feasibility trial
title_fullStr Prehospital optimal shock energy for defibrillation (POSED): A cluster randomised controlled feasibility trial
title_full_unstemmed Prehospital optimal shock energy for defibrillation (POSED): A cluster randomised controlled feasibility trial
title_short Prehospital optimal shock energy for defibrillation (POSED): A cluster randomised controlled feasibility trial
title_sort prehospital optimal shock energy for defibrillation posed a cluster randomised controlled feasibility trial
topic Defibrillation
Out-of-hospital Cardiac Arrest
Ventricular Fibrillation
Electric Countershock
Cardiopulmonary Resuscitation
Feasibility study
url http://www.sciencedirect.com/science/article/pii/S2666520424000201
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