Mechanical and manual chest compressions for resuscitation in in-hospital cardiac arrest

ISRCTN	ISRCTN38139840
DOI	https://doi.org/10.1186/ISRCTN38139840
Secondary identifying numbers	33216

Submission date: 09/01/2017
Registration date: 12/01/2017
Last edited: 14/10/2020

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Circulatory System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

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

Study website

Contact information

Dr Keith Couper
Public

Clinical Trials Unit
University of Warwick
Coventry
CV4 7AL
United Kingdom

ORCID ID	0000-0003-2123-2022
Phone	+44 2476 575923
Email	compresstrial@warwick.ac.uk

Study information

Study design	Randomised; Both; Design type: Treatment, Device, Qualitative
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant 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
Scientific title	A feasibility randomised controlled trial of mechanical chest compression devices for in-hospital cardiac arrest (COMPRESS-RCT)
Study acronym	COMPRESS-RCT
Study objectives	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(s)	West Midlands - Coventry & Warwickshire Research Ethics Committee, 12/09/2016, ref :16/WM/0299
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	01/10/2015
Completion date	30/09/2019

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	Planned Sample Size: 360; UK Sample Size: 360
Total final enrolment	127
Key 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
Key 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
Date of first enrolment	31/01/2017
Date of final enrolment	31/01/2019

Locations

Countries of recruitment

England
United Kingdom

Study participating centres

Birmingham Heartlands Hospital

Heart of England NHS Foundation Trust
Bordesley Green East
Birmingham
B9 5SS
United Kingdom

University Hospital Coventry

University Hospitals Coventry and Warwickshire NHS Trust
Clifford Bridge Road
Coventry
CV2 2DX
United Kingdom

Sandwell General Hospital

Sandwell and West Birmingham Hospitals NHS Trust
Lyndon
West Bromwich
B71 4HJ
United Kingdom

Warwick Hospital

South Warwickshire NHS Foundation Trust
Lakin Road
CV34 5BW
United Kingdom

Blackpool Hospital

Blackpool Teaching Hospitals NHS Foundation Trust
Whinney Heys
Blackpool
FY3 8NR
United Kingdom

Sponsor information

University of Warwick
University/education

Gibbet Hill Road
Coventry
CV4 7AL
England
United Kingdom

Phone	+44 247 652 2746
Email	wmssponsorship@warwick.ac.uk
"ROR"	https://ror.org/01a77tt86

Funders

Funder type

Government

National Institute for Health Research
Government organisation / National government

Alternative name(s): National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
Location: United Kingdom

Results and Publications

Intention to publish date	30/09/2019
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Data sharing statement to be made available at a later date
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.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Protocol article	protocol	30/08/2018	14/08/2019	Yes	No
Results article	results	01/09/2019	14/08/2019	Yes	No
Results article	results	01/09/2019	14/08/2019	Yes	No
Results article	results	01/01/2021	14/10/2020	Yes	No
HRA research summary			28/06/2023	No	No

Editorial Notes

14/10/2020: Publication reference and total final enrolment number added.
14/08/2019: Publication reference added.
21/03/2018: The following updates were made:
1. Three new trial participating centres were added; Sandwell General Hospital (UK), Warwick Hospital (UK), Blackpool Hospital (UK)
2. Primary outcomes were updated