Protocol for a cluster randomised controlled feasibility study of Prehospital Optimal Shock Energy for Defibrillation (POSED)
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, alloc...
| Main Authors: | , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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Elsevier
2022-12-01
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| Series: | Resuscitation Plus |
| Subjects: | |
| Online Access: | http://www.sciencedirect.com/science/article/pii/S2666520422001102 |
| _version_ | 1797980477822337024 |
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| author | Helen Pocock Charles D. Deakin Ranjit Lall Felix Michelet Abraham Contreras Mark Ainsworth-Smith Phil King Anne Devrell Debra E. Smith Gavin D. Perkins |
| author_facet | Helen Pocock Charles D. Deakin Ranjit Lall Felix Michelet Abraham Contreras Mark Ainsworth-Smith Phil King Anne Devrell Debra E. Smith Gavin D. Perkins |
| author_sort | Helen Pocock |
| collection | DOAJ |
| description | 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) 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.Trial registration: ISRCTN16327029. |
| first_indexed | 2024-04-11T05:55:02Z |
| format | Article |
| id | doaj.art-1874530a5b1549e1972cb9528ad9c85a |
| institution | Directory Open Access Journal |
| issn | 2666-5204 |
| language | English |
| last_indexed | 2024-04-11T05:55:02Z |
| publishDate | 2022-12-01 |
| publisher | Elsevier |
| record_format | Article |
| series | Resuscitation Plus |
| spelling | doaj.art-1874530a5b1549e1972cb9528ad9c85a2022-12-22T04:41:54ZengElsevierResuscitation Plus2666-52042022-12-0112100310Protocol for a cluster randomised controlled feasibility study of Prehospital Optimal Shock Energy for Defibrillation (POSED)Helen Pocock0Charles D. Deakin1Ranjit Lall2Felix Michelet3Abraham Contreras4Mark Ainsworth-Smith5Phil King6Anne Devrell7Debra E. Smith8Gavin D. Perkins9Warwick Clinical Trials Unit, Warwick Medical School, University of Warwick, Gibbet Hill Road, Coventry CV4 7AL, United Kingdom; South Central Ambulance Service NHS Foundation Trust, Southern House, Sparrowgrove, Otterbourne, Winchester, SO21 2RU, United Kingdom; Corresponding author at: Warwick Clinical Trials Unit, Warwick Medical School, University of Warwick, Gibbet Hill Road, Coventry CV4 7AL, United Kingdom.South Central Ambulance Service NHS Foundation Trust, Southern House, Sparrowgrove, Otterbourne, Winchester, SO21 2RU, United Kingdom; University Hospital Southampton NHS Foundation Trust, Tremona Road, Southampton SO16 6YD, United KingdomWarwick Clinical Trials Unit, Warwick Medical School, University of Warwick, Gibbet Hill Road, Coventry CV4 7AL, United KingdomWarwick Clinical Trials Unit, Warwick Medical School, University of Warwick, Gibbet Hill Road, Coventry CV4 7AL, United KingdomWarwick Clinical Trials Unit, Warwick Medical School, University of Warwick, Gibbet Hill Road, Coventry CV4 7AL, United KingdomSouth Central Ambulance Service NHS Foundation Trust, Southern House, Sparrowgrove, Otterbourne, Winchester, SO21 2RU, United KingdomSouth Central Ambulance Service NHS Foundation Trust, Southern House, Sparrowgrove, Otterbourne, Winchester, SO21 2RU, United KingdomPPI Representative, Warwick Clinical Trials Unit, Warwick Medical School, University of Warwick, Gibbet Hill Road, Coventry, CV4 7AL, United KingdomPPI Representative, Warwick Clinical Trials Unit, Warwick Medical School, University of Warwick, Gibbet Hill Road, Coventry, CV4 7AL, United KingdomWarwick Clinical Trials Unit, Warwick Medical School, University of Warwick, Gibbet Hill Road, Coventry CV4 7AL, United Kingdom; University Hospitals Birmingham NHS Foundation Trust, Birmingham Heartlands Hospital, Bordesley Green East, Birmingham B9 5SS, United KingdomAims: 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) 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.Trial registration: ISRCTN16327029.http://www.sciencedirect.com/science/article/pii/S2666520422001102DefibrillationOut-of-Hospital Cardiac ArrestVentricular FibrillationElectric CountershockCardiopulmonary ResuscitationFeasibility study |
| spellingShingle | Helen Pocock Charles D. Deakin Ranjit Lall Felix Michelet Abraham Contreras Mark Ainsworth-Smith Phil King Anne Devrell Debra E. Smith Gavin D. Perkins Protocol for a cluster randomised controlled feasibility study of Prehospital Optimal Shock Energy for Defibrillation (POSED) Resuscitation Plus Defibrillation Out-of-Hospital Cardiac Arrest Ventricular Fibrillation Electric Countershock Cardiopulmonary Resuscitation Feasibility study |
| title | Protocol for a cluster randomised controlled feasibility study of Prehospital Optimal Shock Energy for Defibrillation (POSED) |
| title_full | Protocol for a cluster randomised controlled feasibility study of Prehospital Optimal Shock Energy for Defibrillation (POSED) |
| title_fullStr | Protocol for a cluster randomised controlled feasibility study of Prehospital Optimal Shock Energy for Defibrillation (POSED) |
| title_full_unstemmed | Protocol for a cluster randomised controlled feasibility study of Prehospital Optimal Shock Energy for Defibrillation (POSED) |
| title_short | Protocol for a cluster randomised controlled feasibility study of Prehospital Optimal Shock Energy for Defibrillation (POSED) |
| title_sort | protocol for a cluster randomised controlled feasibility study of prehospital optimal shock energy for defibrillation posed |
| topic | Defibrillation Out-of-Hospital Cardiac Arrest Ventricular Fibrillation Electric Countershock Cardiopulmonary Resuscitation Feasibility study |
| url | http://www.sciencedirect.com/science/article/pii/S2666520422001102 |
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