Condition category
Not Applicable
Date applied
07/08/2017
Date assigned
08/08/2017
Last edited
25/10/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Each year, about 30,000 people in the UK suffer an out-of-hospital cardiac arrest. A cardiac arrest occurs when the heart suddenly stops beating properly. Immediate treatment is essential to prevent death. Patients have the best chance of survival when they receive cardiopulmonary resuscitation (CPR) before the ambulance arrives. The ambulance service can coach people to do this over the phone. At the moment, it is not known which way is the best way to instruct people over the phone to ensure they deliver high-quality CPR. Across international CPR guidelines, there is variation in the wording used to describe how best to perform CPR. The aim of this study is to identify the best way to instruct people how to deliver CPR.

Who can participate?
Adults aged over 18 without recent CPR training

What does the study involve?
Participants perform CPR on a manikin based on instructions similar to those given when the ambulance service instruct people over the phone. They are randomly allocated to one of three groups, which each receive a slightly different instruction regarding how hard to press on the chest (push at least 5cm, push approximately 5cm, or push hard and fast). Participants are asked to deliver CPR to a manikin based on these instructions for two minutes and the quality of CPR delivered to the manikin is measured.

What are the possible benefits and risks of participating?
Findings from this study will inform the wording used in international resuscitation guidelines. There are no significant direct benefits or risks associated with taking part in this study. Participants who agree to take part are offered the opportunity to attend a CPR course. Some participants may experience discomfort in the arms or knees, but this discomfort is short-lived.

Where is the study run from?
Warwick Medical School (UK)

When is the study starting and how long is it expected to run for?
December 2016 to April 2018

Who is funding the study?
Resuscitation Council (UK)

Who is the main contact?
Dr Keith Couper

Trial website

Contact information

Type

Scientific

Primary contact

Dr Keith Couper

ORCID ID

http://orcid.org/0000-0003-2123-2022

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

35062

Study information

Scientific title

In adults delivering CPR, does the use of a specific terminology to instruct cardiopulmonary resuscitation delivery CPR instructions affect CPR quality? A randomised controlled manikin trial

Acronym

DIRECT

Study hypothesis

Each year, approximately 30,000 people in the UK suffer an out-of-hospital cardiac arrest. A cardiac arrest occurs when the heart suddenly stops beating properly. Immediate treatment is essential to prevent death. Patients have the best chance of survival when they receive cardiopulmonary resuscitation before the ambulance arrives. In people that have not been trained to do this, the ambulance service can coach people to do this over the phone. At the moment, it is not known which is the best way to instruct people over the phone to ensure they deliver high-quality CPR. Across international CPR guidelines, there is variation in the wording used to describe how best to perform CPR. The aim of this randomised controlled manikin trial is to identify the best way to instruct people how to deliver CPR.

Ethics approval

West Midlands - Edgbaston Research Ethics Committee, 04/07/2017, ref: 17/WM/0234

Study design

Randomised; Interventional; Design type: Treatment, Process of Care, Psychological & Behavioural, Physical

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

Specialty: Critical care, Primary sub-specialty: Critical Care; UKCRC code/ Disease: Generic Health Relevance/ No specific disease

Intervention

Adults without recent CPR training will be invited to take part. They will perform CPR on a manikin, based on instructions similar to those given when the ambulance service instruct people over the phone. They will be randomised using an internet-based randomisation system (1:1:1 ratio) into three groups, which will each receive a slightly different instruction regarding how hard to press on the chest:

Arm 1: chest compression instruction to push “at least 5cm”
Arm 2: chest compression instruction to push “approximately 5cm”
Arm 3: chest compression instruction to push “hard and fast”

They will be asked to deliver CPR to a manikin based on these instructions for two minutes. There will be no follow-up. The quality of CPR delivered to the manikin will be measured.

Intervention type

Other

Phase

Drug names

Primary outcome measures

Mean chest compression depth, measured using a CPR quality meter during the CPR quality assessment

Secondary outcome measures

Measured using a CPR quality meter during the CPR quality assessment:
1. Chest compression rate (min-1)
2. Chest compression count
3. % of chest compessions in target rate range (100-120 compressions per minute)
4. % of chest compressions in target depth range (50-60mm)
5. % delivery of good quality CPR

Overall trial start date

22/12/2016

Overall trial end date

30/04/2018

Reason abandoned

Eligibility

Participant inclusion criteria

1. Provision of written informed consent
2. Aged over 18 years

Participant type

Healthy volunteer

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 330; UK Sample Size: 330

Participant exclusion criteria

1. Physical disability that prevents delivery of CPR for 2 minutes while kneeling on the floor
2. Previous participation in DIRECT study
3. Received practical CPR training in the last 2 years
4. Non-English speaking (to ensure that the information is standardised between groups)
5. NHS employee working in a clinical role

Recruitment start date

31/07/2017

Recruitment end date

31/12/2017

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Warwick Medical School
CV4 7AL
United Kingdom

Sponsor information

Organisation

Heart of England NHS Foundation Trust

Sponsor details

Birmingham Heartlands Hospital
Bordesley Green East
Birmingham
B9 5ST
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

Resuscitation Council (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer reviewed journal in October 2018.

IPD sharing statement:
The data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

01/10/2018

Participant level data

To be made available at a later date

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

25/10/2017: The ISRCTN prospective/retrospective flag compares the date of registration with the recruitment start date and does not include any grace period. The registration of this study was requested through the NIHR Portfolio and was finalised within 6 months of the recruitment starting.