Condition category
Circulatory System
Date applied
09/02/2009
Date assigned
10/02/2009
Last edited
06/05/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

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

Trial website

Contact information

Type

Scientific

Primary contact

Dr Simon Gates

ORCID ID

Contact details

Warwick Medical School Clinical Trials Unit
University of Warwick
Gibbet Hill Campus
Coventry
CV4 7AL
United Kingdom
-
s.gates@warwick.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

HTA 07/37/69

Study information

Scientific title

Cluster randomised controlled trial of the LUCAS™ mechanical chest compression device for out of hospital cardiac arrest

Acronym

PaRAMeDIC

Study hypothesis

The 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™.

More details can be found at: http://www.nets.nihr.ac.uk/projects/hta/073769
Protocol can be found at: http://www.nets.nihr.ac.uk/__data/assets/pdf_file/0008/51785/PRO-07-37-69.pdf

Ethics approval

Not provided at time of registration – submission pending as of 09/02/2009

Study design

Cluster randomised controlled trial

Primary study design

Interventional

Secondary study design

Cluster randomised trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Out of hospital cardiac arrest

Intervention

The 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 type

Device

Phase

Not Applicable

Drug names

Primary outcome measures

Survival 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 measures

1. 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 trial start date

01/06/2009

Overall trial end date

31/08/2013

Reason abandoned

Eligibility

Participant inclusion criteria

1. 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

4,200

Participant exclusion criteria

1. Traumatic cardiac arrest
2. Known or clinically apparent pregnancy

Recruitment start date

01/06/2009

Recruitment end date

31/08/2013

Locations

Countries of recruitment

United Kingdom

Trial participating centre

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

Sponsor information

Organisation

University of Warwick (UK)

Sponsor details

Research Support Services
University House
Coventry
CV4 8UW
United Kingdom
-
P.A.Hedges@warwick.ac.uk

Sponsor type

University/education

Website

http://www2.warwick.ac.uk/

Funders

Funder type

Government

Funder name

Health Technology Assessment Programme

Alternative name(s)

NIHR Health Technology Assessment Programme, HTA

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2010 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/21054860
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/25467566
2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/26917497

Publication citations

  1. Protocol

    Perkins GD, Woollard M, Cooke MW, Deakin C, Horton J, Lall R, Lamb SE, McCabe C, Quinn T, Slowther A, Gates S, , Prehospital randomised assessment of a mechanical compression device in cardiac arrest (PaRAMeDIC) trial protocol., Scand J Trauma Resusc Emerg Med, 2010, 18, 58, doi: 10.1186/1757-7241-18-58.

  2. Results

    Perkins GD, Lall R, Quinn T, Deakin CD, Cooke MW, Horton J, Lamb SE, Slowther AM, Woollard M, Carson A, Smyth M, Whitfield R, Williams A, Pocock H, Black JJ, Wright J, Han K, Gates S; PARAMEDIC trial collaborators, Mechanical versus manual chest compression for out-of-hospital cardiac arrest (PARAMEDIC): a pragmatic, cluster randomised controlled trial, Lancet, 2015, 385, 9972, 947-955, doi: 10.1016/S0140-6736(14)61886-9.

  3. Results

    Pocock H, Deakin CD, Quinn T, Perkins GD, Horton J, Gates S, Human factors in prehospital research: lessons from the PARAMEDIC trial, Emerg Med J, 2016 , doi: 10.1136/emermed-2015-204916.

Additional files

Editorial Notes

06/05/2016: Publication reference added. 29/02/2016: Publication reference added.