COMPRESS-RCT is looking at whether it is possible to carry out a randomised clinical trial to find out if using a mechanical device to deliver chest compressions has any effect on survival and quality of life of patients who have a cardiac arrest in hospital, compared to those treated with manual chest compressions.

Patients who have a cardiac arrest (their heart stops beating) whilst they are staying in one of the hospitals listed below will take part in the study if they are eligible.

We plan for the study to take place at the following NHS hospitals in the West Midlands:

• Birmingham Heartlands Hospital (Heart of England NHS Foundation Trust)

• University Hospital, Coventry (University Hospitals Coventry and Warwickshire NHS Trust)

• Sandwell General Hospital (Sandwell and West Birmingham Hospitals NHS Trust)

• Warwick Hospital (South Warwickshire NHS Foundation Trust)
• Blackpool Hospital (Blackpool Teaching Hospitals NHS Foundation Trust)

A member of the hospital research team will inform patients if they have been involved in the study after the initial emergency has passed. The researcher will provide an information sheet to explain the purpose of the trial, inform the patient of their options, and seek their consent for further participation.

A copy of this information sheet is available here: COMPRESS-RCT Participant Information Sheet 

It is usual for a patient to be asked for their consent before taking part in a study, but this is not possible in this case as treatment must be started without delay and patients will be unconscious. In these circumstances, carrying out research is regulated by English law.

The study protocol and supporting documents have been reviewed and approved by the funding body, the National Institute for Health Research (NIHR); by a NHS Research Ethics Committee (REC); the NHS Confidentiality Advisory Group (CAG) and by the NHS Health Research Authority (HRA). It has also been reviewed by public and patient groups.

If you have participated in the study and do not want your anonymised data to be used in the analysis, please contact the COMPRESS-RCT Trial Coordinator at Warwick Clinical Trials Unit via email or telephone.

Privacy Statement

Individuals randomised in to the COMPRESS trial will have the following information collected by members of the research team at the hospital:

* Initials and baseline demographic information

* Information about their hospital stay and medical history

* Information about the cardiac arrest eventInformation about their recovery

This information will be anonymised and sent to the University of Warwick.

The University of Warwick will only collect identifiable information about individuals where the individual or someone making decisions on their behalf (such as a family member) has explicitly agreed to this.

The University of Warwick is the data controller for the COMPRESS-RCT study. This means they are responsible for looking after your information and ensuring it is used correctly. All information will be kept strictly confidential and accessed by authorised staff only. As with most research, we believe it is in the public interest and have received approval to proceed from the Health Regulatory Authority and Confidentiality Advisory Group.

Research nurses' will send anonymised information securely for data analysis. If a participant explicitly consents, their contact details will also be securely transferred to the University of Warwick Clinical Trials Unit to enable us to contact them to see how well they are recovering after six-months . This information can only be assessed by University of Warwick Clinical Trials Unit staff members who will be contacting you.

Information will be kept for ten years following trial completion. Anonymised data may be used for future research.

Your rights to access, change of move your information are limited, as we need to manage your information in specific ways in order for the research to be reliable and accurate. At all times, participants are able to withdraw from the study, meaning no further data will be collected although information collected up to this point will be retained.

If you are unhappy with the way your data is being managed you can lodge a complaint with the Information Commissioner’s Office by accessing the following link: https://ico.org.uk/concerns/handling/

Or alternatively contact our Data Protection Officer:

GDPR@warwick.ac.uk

Deputy Registrar's Office

University House

University of Warwick

CV4 8UW

Enquiries:

Please direct all general enquiries to:
Trial Manager:

Catherine Lawrence

Tel: 02476 150986

Email: compresstrial at warwick dot ac dot uk