ISRCTN ISRCTN15128211
DOI https://doi.org/10.1186/ISRCTN15128211
Secondary identifying numbers 35062
Submission date
07/08/2017
Registration date
08/08/2017
Last edited
14/08/2019
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Other
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

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

Contact information

Dr Keith Couper
Scientific

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

ORCiD logoORCID ID 0000-0003-2123-2022

Study information

Study designRandomised; Interventional; Design type: Treatment, Process of Care, Psychological & Behavioural, Physical
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details to request a patient information sheet
Scientific titleIn 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
Study acronymDIRECT
Study hypothesisEach 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(s)West Midlands - Edgbaston Research Ethics Committee, 04/07/2017, ref: 17/WM/0234
ConditionSpecialty: Critical care, Primary sub-specialty: Critical Care; UKCRC code/ Disease: Generic Health Relevance/ No specific disease
InterventionAdults 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 typeOther
Primary outcome measureMean chest compression depth, measured using a CPR quality meter during the CPR quality assessment
Secondary outcome measuresMeasured 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 study start date22/12/2016
Overall study end date30/04/2018

Eligibility

Participant type(s)Healthy volunteer
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participantsPlanned Sample Size: 330; UK Sample Size: 330
Total final enrolment330
Participant inclusion criteria1. Provision of written informed consent
2. Aged over 18 years
Participant exclusion criteria1. 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 date31/07/2017
Recruitment end date31/12/2017

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Warwick Medical School
CV4 7AL
United Kingdom

Sponsor information

Heart of England NHS Foundation Trust
Hospital/treatment centre

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

Funders

Funder type

Government

Resuscitation Council (UK)

No information available

Results and Publications

Intention to publish date01/10/2018
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryData sharing statement to be made available at a later date
Publication and dissemination planPlanned publication in a high-impact peer reviewed journal in October 2018.
IPD sharing planThe 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 file version V1.0 25/05/2017 02/04/2019 No No
Results article results 01/09/2019 14/08/2019 Yes No
HRA research summary 28/06/2023 No No

Additional files

ISRCTN15128211_PROTOCOL_V1.0_25May2017.pdf
Uploaded 02/04/2019

Editorial Notes

14/08/2019: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
02/04/2019: Uploaded protocol (not peer reviewed).
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.