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™.
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 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 measure
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 (if study stopped)
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
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
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
Basic results (scientific)
Publication list
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
2017 results in: http://www.ncbi.nlm.nih.gov/pubmed/28393757
2017 post-admission outcomes in: https://www.ncbi.nlm.nih.gov/pubmed/28689046
2018 results in: http://www.ncbi.nlm.nih.gov/pubmed/30056384
Publication citations
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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.
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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.
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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.