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
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
Contact information
Public
Clinical Trials Unit
University of Warwick
Coventry
CV4 7AL
United Kingdom
 ORCID ID |
0000-0003-2123-2022 |
|---|---|
| Phone | +44 2476 575923 |
| 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 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(s) | West Midlands - Coventry & Warwickshire Research Ethics Committee, 12/09/2016, ref :16/WM/0299 |
| 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 |
| 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 |
| Overall study end 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 |
| 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 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
- England
- United Kingdom
Study participating centres
Bordesley Green East
Birmingham
B9 5SS
United Kingdom
Clifford Bridge Road
Coventry
CV2 2DX
United Kingdom
Lyndon
West Bromwich
B71 4HJ
United Kingdom
Lakin Road
CV34 5BW
United Kingdom
Whinney Heys
Blackpool
FY3 8NR
United Kingdom
Sponsor information
University/education
Gibbet Hill Road
Coventry
CV4 7AL
England
United Kingdom
| Phone | +44 247 652 2746 |
|---|---|
| wmssponsorship@warwick.ac.uk | |
"ROR" |
https://ror.org/01a77tt86 |
Funders
Funder type
Government
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
