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Protocol summary

PARAMEDIC TRIAL

Registrations

  • ISRCTN 08233942
  • Ethical approval: England/Wales (09/H1210/69); Scotland (09/MRE00/41)
  • UK Clinical Research Network Portfolio 8253

PICO Question
  • In adult patients sustaining an out of hospital cardiac arrest (P) does the use of LUCAS-2 mechanical chest compression device (I) compared to standard CPR (C) improve 30 day survival (O)

Trial design
  • Cluster randomised controlled trial
  • Vehicles that are in service at participating ambulance stations and may attend eligible patients will be included in the trial and randomised to one of the trial arms, in approximately 2:1 (control : LUCAS) ratio, before the start of recruitment

Inclusion criteria
  • Cardiac arrest in the out of hospital environment on arrival of a trial vehicle
  • Resuscitation attempt is initiated by the attending paramedic, according to JRCALC guidelines
  • The patient is believed to be aged 18 years or over

Exclusion criteria
  • Traumatic cardiac arrest
  • Known or clinically apparent pregnancy

Primary outcome
  • Survival at 30 days after enrolment

Secondary outcomes
  • Survived event (return of spontaneous circulation at point of handover to hospital staff) and survival at 12 months
  • Health related quality of life at 3 and 12 months
  • Neurological outcome at 3 months (CPC)
  • Neurological outcome at 12 months (MMSE; PTSD; HAD)
  • Length of stay (hospital and ITU)
  • Safety
  • Economic evaluation

Target recruitment
  • 4400 participants

Centres
  • 3 (West Midlands Ambulance, Scottish Ambulance, Welsh Ambulance)

Funder
  • NIHR HTA Programme (HTA 07/37/69)

Chief Investigators
  • Dr Gavin Perkins and Dr Simon Gates, University of Warwick

Sponsor
  • University of Warwick (Dr Peter Hedges)

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