Prehospital Randomised Assessment of Mechanical compression Device In Cardiac arrest

ISRCTN ISRCTN08233942
DOI https://doi.org/10.1186/ISRCTN08233942
Secondary identifying numbers HTA 07/37/69
Submission date
09/02/2009
Registration date
10/02/2009
Last edited
30/07/2018
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Background and study aims
A cardiac arrest happens when the heart stops pumping blood around the body. When people suffer a cardiac arrest out of hospital, the main treatment is cardiopulmonary resuscitation (CPR), during which the blood circulation is maintained by repeatedly compressing the chest. It has been suggested that mechanical devices may be more effective at providing chest compression than people, as they do not tire, can operate in difficult conditions such as a moving ambulance, and can provide compressions of the required depth and frequency sustained for a long period. The LUCAS device (Lund University Cardiopulmonary Assistance System) is one such machine. It was adopted by a few ambulance services in the UK several years ago but it is not yet known whether it improves survival rates. In this study we aim to find out whether using the LUCAS device to provide CPR enables more patients to survive than using standard manual chest compression.

Who can participate?
Patients aged 18 years or over in cardiac arrest out of hospital

What does the study involve?
Participating ambulance service vehicles are randomly allocated to either carry a LUCAS device or to not carry a LUCAS. If the vehicle carries a LUCAS it is used to provide chest compressions for all cardiac arrests where resuscitation is attempted. If the vehicle does not carry a LUCAS then standard manual chest compression is used.

What are the possible benefits and risks of participating?
Not provided at time of registration

Where is the study run from?
Warwick Medical School Clinical Trials Unit (UK)

When is the study starting and how long is it expected to run for?
June 2009 to August 2013

Who is funding the study?
Health Technology Assessment Programme (UK)

Who is the main contact?
Dr Simon Gates
s.gates@warwick.ac.uk

Contact information

Dr Simon Gates
Scientific

Warwick Medical School Clinical Trials Unit
University of Warwick
Gibbet Hill Campus
Coventry
CV4 7AL
United Kingdom

Email s.gates@warwick.ac.uk

Study information

Study designCluster randomised controlled trial
Primary study designInterventional
Secondary study designCluster randomised trial
Study setting(s)Other
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details to request a patient information sheet
Scientific titleCluster randomised controlled trial of the LUCAS™ mechanical chest compression device for out of hospital cardiac arrest
Study acronymPaRAMeDIC
Study objectivesThe primary objective of this trial is to evaluate the effect on mortality up to discharge from hospital of using LUCAS™ rather than manual chest compression during resuscitation by paramedics after out of hospital cardiac arrest. Secondary objectives of the study are to evaluate the effects of LUCAS™ on survival to 12 months, neurological outcomes of survivors and cost-effectiveness of LUCAS™.
Ethics approval(s)Not provided at time of registration – submission pending as of 09/02/2009
Health condition(s) or problem(s) studiedOut of hospital cardiac arrest
InterventionThe unit of randomisation is the ambulance service vehicle (rapid response vehicles and ambulances).

The intervention arm will receive resuscitation according to the Resuscitation Council (UK) 27 and JRCALC Advanced Life Support Guidelines, with the exception that the LUCAS™ device will be deployed to replace standard manual chest compressions.

The control arm will receive resuscitation according to the Resuscitation Council (UK) and JRCALC Advanced Life Support Guidelines.
Intervention typeDevice
Pharmaceutical study type(s)
PhaseNot Applicable
Drug / device / biological / vaccine name(s)
Primary outcome measureSurvival to hospital discharge (the point at which the patient is discharged from the hospital acute care unit regardless of neurological status, outcome or destination).
Secondary outcome measures1. Survived event (sustained return of spontaneous circulation [ROSC], with spontaneous circulation until admission and transfer of care to medical staff at the receiving hospital)
2. Survival to 12 months
3. Health related quality of life at 3 and 12 months (SF-12® Health Survey and Euroqol EQ-5D)
4. Neurological outcome at discharge from hospital, assessed by the Cerebral Performance Category (CPC) score 1-2 v 3-5
5. Neurological outcome at 12 months, assessed by the telephone version of Mini Mental State Examination (T3MS)
6. Anxiety and depression at 12 months, assessed by the Hospital Anxiety and Depression Scale (HADS)
7. Post-traumatic stress at 12 months, assessed by the post-traumatic stress disorder (PTSD) civilian checklist (PCL-C)
8. Hospital length of stay
9. Intensive care length of stay
Overall study start date01/06/2009
Completion date31/08/2013

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants4,200
Key inclusion criteria1. Patients (both males and females) in cardiac arrest in the out of hospital environment
2. Resuscitation attempt is initiated by the attending paramedic, according to Joint Royal Colleges Ambulance Liaison Committee (JRCALC) guidelines
3. Patient is believed to be aged 18 years or over
Key exclusion criteria1. Traumatic cardiac arrest
2. Known or clinically apparent pregnancy
Date of first enrolment01/06/2009
Date of final enrolment31/08/2013

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Warwick Medical School Clinical Trials Unit
Coventry
CV4 7AL
United Kingdom

Sponsor information

University of Warwick (UK)
University/education

Research Support Services
University House
Coventry
CV4 8UW
England
United Kingdom

Email P.A.Hedges@warwick.ac.uk
Website http://www2.warwick.ac.uk/
ROR logo "ROR" https://ror.org/01a77tt86

Funders

Funder type

Government

Health Technology Assessment Programme
Government organisation / National government
Alternative name(s)
NIHR Health Technology Assessment Programme, HTA
Location
United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Protocol article protocol 05/11/2010 Yes No
Results article results 14/03/2015 Yes No
Results article results 01/08/2016 Yes No
Results article results 01/03/2017 Yes No
Other publications post-admission outcomes 01/09/2017 Yes No
Results article results 28/07/2018 Yes No

Editorial Notes

30/07/2018: Publication reference added.
19/10/2017: Publication reference added.
11/04/2017: Publication reference added.
06/05/2016: Publication reference added.
29/02/2016: Publication reference added.