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
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
| Study design | Cluster randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Cluster randomised trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | |
| 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 study start date | 01/06/2009 |
| Completion date | 31/08/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 4,200 |
| 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
- England
- United Kingdom
Study participating centre
CV4 7AL
United Kingdom
Sponsor information
University/education
Research Support Services
University House
Coventry
CV4 8UW
England
United Kingdom
| P.A.Hedges@warwick.ac.uk | |
| Website | http://www2.warwick.ac.uk/ |
"ROR" |
https://ror.org/01a77tt86 |
Funders
Funder type
Government
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 share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not 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.
