Prehospital Randomised Assessment of Mechanical compression Device In Cardiac arrest
| ISRCTN | ISRCTN08233942 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN08233942 |
| Protocol serial number | HTA 07/37/69 |
| Sponsor | University of Warwick (UK) |
| Funder | Health Technology Assessment Programme |
- 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
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
Scientific
Warwick Medical School Clinical Trials Unit
University of Warwick
Gibbet Hill Campus
Coventry
CV4 7AL
United Kingdom
| s.gates@warwick.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Cluster randomised controlled trial |
| Secondary study design | Cluster randomised trial |
| Study type | Participant information sheet |
| Scientific title | Cluster randomised controlled trial of the LUCAS™ mechanical chest compression device for out of hospital cardiac arrest |
| Study acronym | PaRAMeDIC |
| Study objectives | 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(s) | Not provided at time of registration – submission pending as of 09/02/2009 |
| Health condition(s) or problem(s) studied | 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 / device / biological / vaccine name(s) | |
| Primary outcome measure(s) |
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). |
| Key secondary outcome measure(s) |
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) |
| Completion date | 31/08/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 4200 |
| Key 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 |
| Key exclusion criteria | 1. Traumatic cardiac arrest 2. Known or clinically apparent pregnancy |
| Date of first enrolment | 01/06/2009 |
| Date of final enrolment | 31/08/2013 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
CV4 7AL
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 14/03/2015 | Yes | No | |
| Results article | results | 01/08/2016 | Yes | No | |
| Results article | results | 01/03/2017 | Yes | No | |
| Results article | results | 28/07/2018 | Yes | No | |
| Protocol article | protocol | 05/11/2010 | Yes | No | |
| Other publications | post-admission outcomes | 01/09/2017 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
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.
