Condition category
Circulatory System
Date applied
09/01/2017
Date assigned
12/01/2017
Last edited
12/01/2017
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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)

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

www.warwick.ac.uk/compresstrial

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

http://www2.warwick.ac.uk/fac/med/research/hscience/ctu/trials/compress-rct/public/compress-rct_participant_info_sheet_v2.0_16.11.2016_final_website_version.pdf

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

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

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

Publication citations

Additional files

Editorial Notes