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Prehospital randomised assessment of a mechanical compression device in cardiac arrest (PaRAMeDIC) trial protocol

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Perkins, Gavin D., Woollard, Malcolm, Cooke, Matthew, MB ChB, Deakin, Charles D., Horton, Jessica, Lall, Ranjit, Lamb, S. E. (Sallie E.), McCabe, Chris (Christopher J.), 1967-, Quinn, Tom, 1961-, Slowther, Anne and Gates, Simon. (2010) Prehospital randomised assessment of a mechanical compression device in cardiac arrest (PaRAMeDIC) trial protocol. Scandinavian Journal of Trauma, Resuscitation and Emergency Medicine, Vol.18 (No.58). ISSN 1757-7241

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Official URL: http://dx.doi.org/10.1186/1757-7241-18-58

Abstract

Background Survival after out-of-hospital cardiac arrest is closely linked to the quality of CPR, but in real life, resuscitation during pre-hospital care and ambulance transport is often suboptimal. Mechanical chest compression devices deliver consistent chest compressions, are not prone to fatigue and could potentially overcome some of the limitations of manual chest compression. However, there is no high-quality evidence that they improve clinical outcomes, or that they are cost effective. The Pre-hospital Randomised Assessment of a Mechanical Compression Device In Cardiac Arrest (PARAMEDIC) trial is a pragmatic cluster randomised study of the LUCAS-2 device in adult patients with non-traumatic out-of-hospital cardiac arrest. Methods The primary objective of this trial is to evaluate the effect of chest compression using LUCAS-2 on mortality at 30 days post out-of-hospital cardiac arrest, compared with manual chest compression. Secondary objectives of the study are to evaluate the effects of LUCAS-2 on survival to 12 months, cognitive and quality of life outcomes and cost-effectiveness. Methods: Ambulance service vehicles will be randomised to either manual compression (control) or LUCAS arms. Adult patients in out-of-hospital cardiac arrest, attended by a trial vehicle will be eligible for inclusion. Patients with traumatic cardiac arrest or who are pregnant will be excluded. The trial will recruit approximately 4000 patients from England, Wales and Scotland. A waiver of initial consent has been approved by the Research Ethics Committees. Consent will be sought from survivors for participation in the follow-up phase. Conclusion The trial will assess the clinical and cost effectiveness of the LUCAS-2 mechanical chest compression device. Trial Registration: The trial is registered on the International Standard Randomised Controlled Trial Number Registry (ISRCTN08233942).

Item Type:	Journal Article
Subjects:	R Medicine > R Medicine (General)
Divisions:	Faculty of Medicine > Warwick Medical School > Health Sciences Faculty of Medicine > Warwick Medical School
Library of Congress Subject Headings (LCSH):	Cardiac arrest -- Treatment -- Technological innovations, Cardiac resuscitation
Journal or Publication Title:	Scandinavian Journal of Trauma, Resuscitation and Emergency Medicine
Publisher:	BioMed central Ltd.
ISSN:	1757-7241
Date:	5 November 2010
Volume:	Vol.18
Number:	No.58
Identification Number:	10.1186/1757-7241-18-58
Status:	Peer Reviewed
Publication Status:	Published
Access rights to Published version:	Open Access
Funder:	National Institute for Health Research (Great Britain) (NIHR), Advantage West Midlands (AWM)
References:	1. Atwood C, Eisenberg MS, Herlitz J, Rea TD: Incidence of EMS-treated out-ofhospital cardiac arrest in Europe. Resuscitation 2005, 67(1):75-80. 2. Berdowski J, Berg RA, Tijssen JG, Koster RW: Global incidences of out-ofhospital cardiac arrest and survival rates: Systematic review of 67 prospective studies. Resuscitation 2010. 3. London Ambulance Service Cardiac Arrest Annual Report 2008/9 [http://www.londonambulance.nhs.uk/about_us/idoc.ashx?docid=498ba02b-466b- 48be-8d4d-7dcc3c38bfd0&version=-1] 4. Association. AS, Committee JRCAL: National Cardiac Arrest Audit Report. 2006. 5. Wik L, Steen PA, Bircher NG: Quality of bystander cardiopulmonary resuscitation influences outcome after prehospital cardiac arrest. Resuscitation 1994, 28(3):195-203. 6. Edelson DP, Abella BS, Kramer-Johansen J, Wik L, Myklebust H, Barry AM, Merchant RM, Hoek TL, Steen PA, Becker LB: Effects of compression depth and pre-shock pauses predict defibrillation failure during cardiac arrest. Resuscitation 2006, 71(2):137-145. 7. Kramer-Johansen J, Myklebust H, Wik L, Fellows B, Svensson L, Sorebo H, Steen PA: Quality of out-of-hospital cardiopulmonary resuscitation with real time automated feedback: a prospective interventional study. Resuscitation 2006, 71(3):283-292. 8. Hightower D, Thomas SH, Stone CK, Dunn K, March JA: Decay in quality of closed-chest compressions over time. Annals of Emergency Medicine 1995, 26(3):300-303. 9. International Liaison Committee on Resuscitation: 2005 International Consensus on Cardiopulmonary Resuscitation and Emergency Cardiovascular Care Science with Treatment Recommendations. Part 2: Adult basic life support. Resuscitation 2005, 67(2-3):187-201. 10. Steen S, Liao Q, Pierre L, Paskevicius A, Sjoberg T: Evaluation of LUCAS, a new device for automatic mechanical compression and active decompression resuscitation. Resuscitation 2002, 55(3):285-299. 11. Perkins GD, Brace S, Gates S: Mechanical chest-compression devices: current and future roles. Curr Opin Crit Care 2010, 16(3):203-210. 12. Jacobs I: Mechanical chest compression devices--will we ever get the evidence? Resuscitation 2009, 80(10):1093-1094. 13. Medical Research Council: MRC guidelines for good clinical practice in clinical trials. London: Medical Research Council; 1998. 14. A randomised controlled trial of the LUCAS mechanical compression/decompression device for out of hospital cardiac arrest. [LUCASUK] [http://www.hta.ac.uk/project/1845.asp] 15. Paramedic trial website [www.warwick.ac.uk/go/paramedic] 16. Pell JP, Sirel J, Marsden AK, Cobbe SM: Seasonal variations in out of hospital cardiopulmonary arrest. Heart 1999, 82(6):680-683. 17. Eldridge S, Kerry S, Torgerson DJ: Bias in identifying and recruiting participants in cluster randomised trials: what can be done? BMJ 2009, 339:b4006. 18. Recognition of Life Extinct by Ambulance Clinicians [http://www2.warwick.ac.uk/fac/med/research/hsri/emergencycare/prehospitalcare/jr calcstakeholderwebsite/guidelines/recognition_of_life_extinct_by_ambulance_clinici ans_2006.pdf] 19. Deakin C, Nolan JP, Perkins GD: Advanced Life Support Guidelines for the UK. In Resuscitation Guidelines for the UK. Edited by Handley A: Resuscitation Council (UK) 2005. 20. JRCALC Advanced cardiac life support guidelines [http://www2.warwick.ac.uk/fac/med/research/hsri/emergencycare/prehospitalcare/jr calcstakeholderwebsite/guidelines/adult_advanced_life_support_als_2006.pdf] 21. Calculation of sample size for stroke trials assessing functional outcome: comparison of binary and ordinal approaches. Int J Stroke 2008, 3(2):78-84. 22. Campbell MK, Elbourne DR, Altman DG, group C: CONSORT statement: extension to cluster randomised trials.[see comment]. BMJ 2004, 328(7441):702- 708. 23. Altman DG, Bland JM: Interaction revisited: the difference between two estimates.[see comment]. BMJ 2003, 326(7382):219. 24. Ware JE, Kolinski M, Keller SD: How to Score the SF-12 Physical and Mental Health Summaries: A User’s Manual. Boston, MA: The Health Institute, New England Medical Centre; 1995. 25. Brazier JE, Roberts J: The estimation of a preference-based measure of health from the SF-12. Medical Care 2004, 42(9):851-859.
URI:	http://wrap.warwick.ac.uk/id/eprint/3621