Resuscitation Plus (Mar 2024)
Route of drug administration in out-of-hospital cardiac arrest: A protocol for a randomised controlled trial (PARAMEDIC-3)
- Keith Couper,
- Chen Ji,
- Ranjit Lall,
- Charles D Deakin,
- Rachael Fothergill,
- John Long,
- James Mason,
- Felix Michelet,
- Jerry P Nolan,
- Henry Nwankwo,
- Tom Quinn,
- Anne-Marie Slowther,
- Michael A Smyth,
- Alison Walker,
- Loraine Chowdhury,
- Chloe Norman,
- Laurille Sprauve,
- Kath Starr,
- Sara Wood,
- Steve Bell,
- Gemma Bradley,
- Martina Brown,
- Shona Brown,
- Karl Charlton,
- Alison Coppola,
- Charlotte Evans,
- Christine Evans,
- Theresa Foster,
- Michelle Jackson,
- Justin Kearney,
- Nigel Lang,
- Adam Mellett-Smith,
- Ria Osborne,
- Helen Pocock,
- Nigel Rees,
- Robert Spaight,
- Belinda Tibbetts,
- Gregory A. Whitley,
- Jason Wiles,
- Julia Williams,
- Adam Wright,
- Gavin D Perkins
Affiliations
- Keith Couper
- Warwick Clinical Trials, University of Warwick, Coventry, UK; Critical Care Unit, University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK
- Chen Ji
- Warwick Clinical Trials, University of Warwick, Coventry, UK
- Ranjit Lall
- Warwick Clinical Trials, University of Warwick, Coventry, UK
- Charles D Deakin
- University Hospital Southampton NHS Foundation Trust, Southampton, UK; South Central Ambulance NHS Foundation Trust, Otterbourne, UK
- Rachael Fothergill
- Warwick Clinical Trials, University of Warwick, Coventry, UK; Clinical Audit and Research Unit, London Ambulance Service, London, UK
- John Long
- Warwick Clinical Trials, University of Warwick, Coventry, UK
- James Mason
- Warwick Clinical Trials, University of Warwick, Coventry, UK
- Felix Michelet
- Warwick Clinical Trials, University of Warwick, Coventry, UK
- Jerry P Nolan
- Warwick Clinical Trials, University of Warwick, Coventry, UK; Department of Anaesthesia, Royal United Hospitals Bath NHS Foundation Trust, Bath, UK
- Henry Nwankwo
- Warwick Clinical Trials, University of Warwick, Coventry, UK
- Tom Quinn
- Kingston University, London, UK
- Anne-Marie Slowther
- Division of Health Sciences, Warwick Medical School, University of Warwick, Coventry, UK
- Michael A Smyth
- Warwick Clinical Trials, University of Warwick, Coventry, UK
- Alison Walker
- West Midlands Ambulance Service University NHS Foundation Trust, Brierly Hill, UK; Emergency Department, Harrogate and District NHS Foundation Trust, Harrogate, UK
- Loraine Chowdhury
- Warwick Clinical Trials, University of Warwick, Coventry, UK
- Chloe Norman
- Warwick Clinical Trials, University of Warwick, Coventry, UK
- Laurille Sprauve
- Warwick Clinical Trials, University of Warwick, Coventry, UK
- Kath Starr
- Warwick Clinical Trials, University of Warwick, Coventry, UK
- Sara Wood
- Warwick Clinical Trials, University of Warwick, Coventry, UK
- Steve Bell
- North West Ambulance Service NHS Trust, Bolton, UK
- Gemma Bradley
- Research and Development Department, South East Coast Ambulance Service NHS Foundation Trust, Crawley, UK
- Martina Brown
- South Central Ambulance NHS Foundation Trust, Otterbourne, UK
- Shona Brown
- East of England Ambulance Service NHS Trust, Melbourn, UK
- Karl Charlton
- North East Ambulance Service NHS Foundation Trust, Newcastle upon Tyne, UK
- Alison Coppola
- South Western Ambulance Service NHS Foundation Trust, Exeter, UK
- Charlotte Evans
- Welsh Ambulance Services NHS Trust, Cwmbran, UK
- Christine Evans
- West Midlands Ambulance Service University NHS Foundation Trust, Brierly Hill, UK
- Theresa Foster
- East of England Ambulance Service NHS Trust, Melbourn, UK
- Michelle Jackson
- North East Ambulance Service NHS Foundation Trust, Newcastle upon Tyne, UK
- Justin Kearney
- Clinical Audit and Research Unit, London Ambulance Service, London, UK
- Nigel Lang
- Devon Air Ambulance Trust, Exeter, UK
- Adam Mellett-Smith
- Warwick Clinical Trials, University of Warwick, Coventry, UK; Clinical Audit and Research Unit, London Ambulance Service, London, UK
- Ria Osborne
- South Western Ambulance Service NHS Foundation Trust, Exeter, UK
- Helen Pocock
- Warwick Clinical Trials, University of Warwick, Coventry, UK; South Central Ambulance NHS Foundation Trust, Otterbourne, UK
- Nigel Rees
- Welsh Ambulance Services NHS Trust, Cwmbran, UK
- Robert Spaight
- East Midlands Ambulance Service NHS Trust, Nottingham, UK
- Belinda Tibbetts
- Devon Air Ambulance Trust, Exeter, UK
- Gregory A. Whitley
- East Midlands Ambulance Service NHS Trust, Nottingham, UK
- Jason Wiles
- West Midlands Ambulance Service University NHS Foundation Trust, Brierly Hill, UK
- Julia Williams
- Research and Development Department, South East Coast Ambulance Service NHS Foundation Trust, Crawley, UK; Department of Paramedic Science, University of Hertfordshire, Hatfield, UK
- Adam Wright
- North West Ambulance Service NHS Trust, Bolton, UK
- Gavin D Perkins
- Warwick Clinical Trials, University of Warwick, Coventry, UK; Critical Care Unit, University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK; Corresponding author at: Warwick Clinical Trials, University of Warwick, Coventry, UK.
- Journal volume & issue
-
Vol. 17
p. 100544
Abstract
Aims: The PARAMEDIC-3 trial evaluates the clinical and cost-effectiveness of an intraosseous first strategy, compared with an intravenous first strategy, for drug administration in adults who have sustained an out-of-hospital cardiac arrest. Methods: PARAMEDIC-3 is a pragmatic, allocation concealed, open-label, multi-centre, superiority randomised controlled trial. It will recruit 15,000 patients across English and Welsh ambulance services. Adults who have sustained an out-of-hospital cardiac arrest are individually randomised to an intraosseous access first strategy or intravenous access first strategy in a 1:1 ratio through an opaque, sealed envelope system. The randomised allocation determines the route used for the first two attempts at vascular access. Participants are initially enrolled under a deferred consent model.The primary clinical-effectiveness outcome is survival at 30-days. Secondary outcomes include return of spontaneous circulation, neurological functional outcome, and health-related quality of life. Participants are followed-up to six-months following cardiac arrest. The primary health economic outcome is incremental cost per quality-adjusted life year gained. Conclusion: The PARAMEDIC-3 trial will provide key information on the clinical and cost-effectiveness of drug route in out-of-hospital cardiac arrest.Trial registration: ISRCTN14223494, registered 16/08/2021, prospectively registered.
