Plain English Summary
Background and study aims
A cardiac arrest is a serious medical condition where the heart suddenly stops pumping blood around the body. It can be fatal and so when someone has a cardiac arrest, immediate treatment is essential. Chest compressions are an essential treatment for cardiac arrest patients, but are often difficult for a person to deliver to a high standard (manual chest compressions). A mechanical chest compression device can be used to deliver chest compressions (mechanical chest compressions) instead of a person. Every year, 35,000 patients have a cardiac arrest in UK hospitals. However, less than one in five patients survives to leave hospital. When someone has a cardiac arrest, immediate treatment is essential. Small studies suggest using these devices may improve patient survival when used as part of treatment for cardiac arrest patients in hospital. The aim of this study is to conduct a small-scale study in order to find out if a large study looking comparing these two treatments would be feasible.
Who can participate?
Adults whose heart stops while they are in hospital.
What does the study involve?
Patients who have a cardiac arrest all receive manual (by hand) chest compressions initially. When the device arrives at the cardiac arrest, eligible patients are randomly allocated to continue receiving manual chest compressions or to switch to mechanical (delivered by a machine) chest compressions. For all participants, the allocated treatment is delivered for the duration of the cardiac arrest (usually between 20 minutes and two hours). Participants in both groups are followed up until they are discharged from hospital and again 30 days and six months later. Follow up involves the researchers reviewing medical records and participants completing questionnaires about their quality of life.
What are the possible benefits and risks of participating?
The key potential benefit associated with use of the mechanical device is the possibility of improved delivery of chest compressions. The key risk is that deployment of the device requires short pauses in chest compressions. Cardiac arrest teams deploying the device will receive special training so that they can use devices effectively.
Where is the study run from?
1. Birmingham Heartlands Hospital (UK)
2. University Hospital Coventry (UK)
3. Sandwell General Hospital (UK)
4.Warwick Hospital (UK)
5.Blackpool Hospital (UK)
When is the study starting and how long is it expected to run for?
October 2015 to September 2019
Who is funding the study?
National Institute for Health Research (UK)
Who is the main contact?
Dr Keith Couper
compresstrial@warwick.ac.uk
Trial website
Contact information
Type
Public
Primary contact
Dr Keith Couper
ORCID ID
http://orcid.org/0000-0003-2123-2022
Contact details
Clinical Trials Unit
University of Warwick
Coventry
CV4 7AL
United Kingdom
+44 2476 575923
compresstrial@warwick.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
33216
Study information
Scientific title
A feasibility randomised controlled trial of mechanical chest compression devices for in-hospital cardiac arrest (COMPRESS-RCT)
Acronym
COMPRESS-RCT
Study hypothesis
The aim of this study is to assess the feasibility of undertaking a randomised controlled effectiveness trial of mechanical chest compression devices in in-hospital cardiac arrest.
Ethics approval
West Midlands - Coventry & Warwickshire Research Ethics Committee, 12/09/2016, ref :16/WM/0299
Study design
Randomised; Both; Design type: Treatment, Device, Qualitative
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Specialty: Cardiovascular disease, Primary sub-specialty: Heart Failure; UKCRC code/ Disease: Cardiovascular/ Other forms of heart disease
Intervention
Participants are randomised in a 3:1 ratio to receive either mechanical chest compressions or manual chest compressions. Randomisation will be done by opening an opaque envelope that is kept with the device following confirmation of eligibility.
Participants in the mechanical chest compression arm will receive mechanical chest compressions delivered by the LUCAS-2 or LUCAS-3 device (Joliffe AB/ Physio-Control, Lund, Sweden).
Participants in the manual chest compression arm will continue to receive chest compressions delivered by a human.
The allocated treatment will be delivered for the duration of the cardiac arrest event (usually around 20-minutes, but may be up to two hours).
Participants will be followed-up to six-months and consists of review of medical records and completion of quality of life questionnaires.
Intervention type
Other
Phase
Drug names
Primary outcome measures
Current Primary outcome measure, as of 21/03/2018:
Proportion of eligible patients that are randomised during operational recruitment hours over the entire study period.
Previous Primary outcome measure:
Proportion of eligible participants randomised over the entire study period
Secondary outcome measures
Feasibility outcome measures:
1. Proportion of patients randomised outside of weekday daytime hours is assessed at the end of the study
2. Device deployment time (compression pause associated with device deployment) is assessed at the end of the study
3. Proportion of patients/consultees agreeing to ongoing study participation is assessed at the end of the study
4. Success of study blinding procedures is assessed at the end of the study
5. Proportion of patients with complete follow-up data is assessed at the end of the study
6. Proportion of patients with analysable chest compression quality data is assessed at the end of the study
Patient outcome measures:
1. Return of spontaneous circulation is assessed by reviewing patient notes 20 minutes following cardiac arrest
2. Survival is assessed by reviewing patient notes at hospital discharge, 30 days and 6 months
3. Neurological outcome is assessed using the cerebral performance category at discharge and modified rankin score at discharge and 6 months
4. Hospital/critical care length of stay is measured by reviewing patient notes at the time of discharge
5. Quality of life is measured using the EQ-5D and SF-12 at discharge and 6 months
Process outcome measure:
CPR quality (rate, depth, flow-fraction, pauses- pre-,post-, peri-shock) is assessed by reviewing defibrillator and/ or mechanical device data during cardiac arrest.
Safety outcome measure:
Device related adverse events are measured by reviewing patient notes up to the point of discharge
Overall trial start date
01/10/2015
Overall trial end date
30/09/2019
Reason abandoned
Eligibility
Participant inclusion criteria
1. Sustain an in-hospital cardiac arrest and resuscitation is attempted by a hospital cardiac arrest team trained in the use of the mechanical chest compression device
2. In a non-shockable rhythm (pulseless electrical activity or asystole) at the time of eligibility assessment
3. Known or believed to be aged 18 years or over
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Planned Sample Size: 360; UK Sample Size: 360
Participant exclusion criteria
1. Patient has valid do not attempt cardiopulmonary resuscitation order
2. Known or clinically apparent pregnancy
3. Cardiac arrest where use of a mechanical chest compression device is contra-indicated (e.g. following cardiac surgery, thoracic trauma, patient size)
4. Known previous study participation
5. Patient requiring use of mechanical chest compression device as part of routine clinical care
6. Patient known to be detained by Her Majesty’s Prison Service
Recruitment start date
31/01/2017
Recruitment end date
31/01/2019
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Birmingham Heartlands Hospital
Heart of England NHS Foundation Trust
Bordesley Green East
Birmingham
B9 5SS
United Kingdom
Trial participating centre
University Hospital Coventry
University Hospitals Coventry and Warwickshire NHS Trust
Clifford Bridge Road
Coventry
CV2 2DX
United Kingdom
Trial participating centre
Sandwell General Hospital
Sandwell and West Birmingham Hospitals NHS Trust
Lyndon
West Bromwich
B71 4HJ
United Kingdom
Trial participating centre
Warwick Hospital
South Warwickshire NHS Foundation Trust,
Lakin Road,
CV34 5BW
United Kingdom
Trial participating centre
Blackpool Hospital
Blackpool Teaching Hospitals NHS Foundation Trust,
Whinney Heys
Blackpool
FY3 8NR
United Kingdom
Sponsor information
Organisation
University of Warwick
Sponsor details
Gibbet Hill Road
Coventry
CV4 7AL
United Kingdom
+44 247 652 2746
wmssponsorship@warwick.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
Government
Funder name
National Institute for Health Research
Alternative name(s)
NIHR
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Planned publication in a high-impact peer reviewed journal
IPD Sharing plan:
The current data sharing plans for the current study are unknown and will be made available at a later date.
Intention to publish date
30/09/2019
Participant level data
To be made available at a later date
Results - basic reporting
Publication summary