Compression Only CardioPulmonary Resuscitation in telephone-assisted bystanders (COCPR IV)

ISRCTN	ISRCTN15634337
DOI	https://doi.org/10.1186/ISRCTN15634337
Secondary identifying numbers	V1

Submission date: 07/07/2016
Registration date: 09/07/2016
Last edited: 12/10/2017

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

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Background and study aims
High quality chest compressions are vital for survival after a cardiac arrest (heart attack). Therefore bystanders are encouraged to act decisively in the presence of a cardiac arrest victim. Telephone instructions are given by the emergency services responding to emergency calls. Unfortunately the quality of chest compression is usually inefficient because bystanders are often not trained. The aim of this study is to improve the quality of chest compression using a smartphone application which transmits data from the smartphone accelerometer to an external webpage, where the emergency services dispatcher is able to interpret CPR efforts.

Who can participate?
Healthy volunteers aged 18 and over

What does the study involve?
The study involves a simulated 10-minute resuscitation performed on a manikin. Over the telephone, emergency services provide instructions on how to resuscitate the victim (chest compression only resuscitation). Participants are randomly allocated to one of two groups. One group receives standard instructions given by emergency services over the phone. The other group uses the smartphone app as real-time feedback while performing chest compressions with the smartphone on the top of the manikin's chest.

What are the possible benefits and risks of participating?
The benefit will be improved basic life support skills. There are no anticipated risks.

Where is this study run from?
This study is organised by the Department of Emergency Medicine of the Medical University of Vienna. The study venue is a large shopping hall.

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

Who is funding the study?
Not provided at time of registration

Who is the main contact?
Dr Raphael van Tulder
raphael.van-tulder@meduniwien.ac.at

Study website

Contact information

Dr Raphael van Tulder
Scientific

Waehringerguertel 18-20/6D
Vienna
1090
Austria

ORCID ID	0000-0002-0929-8988
Phone	+43 (0)140 4001 9640
Email	Raphael.van-tulder@meduniwien.ac.at

Study information

Study design	Prospective randomized-controlled simulation trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Community
Study type	Other
Participant information sheet	Not available in web format, please use contact details to request a participant information sheet
Scientific title	Using a smartphone accelerometer for real-time feedback in a telephone-assisted, bystander CPR to improve quality of CPR: a prospective, randomized simulation study
Study acronym	COCPR IV
Study objectives	Chest compression rate and/or compression depth can be positively influenced by the dispatcher using the new smartphone application visualizing resuscitation efforts using the accelerometer.
Ethics approval(s)	The ethics committee of the Medical University of Vienna, 21/03/2016, ref: 1103/2016
Health condition(s) or problem(s) studied	Cardiopulmonary resuscitation, dispatch life support, quality of CPR
Intervention	The scenario is planned as an out of hospital, telephone assisted, bystander CPR. Substantial information about circumstances (at home, compression only, telephone assisted bystander CPR) is given prior to participation. Outcome is blinded to the participants. After informed consent, participants are guided to a simulation room where the manikin is prepared. Only minimal study staff will have access to the scenario room to avoid distractions. The study staff's assignment is documentation of parameters and not to be involved in bystander CPR. Participants will be staffed with a telephone to call the Emergency Dispatch Centre (EDC). In the EDC, a professional emergency dispatcher will be providing verbal prompts via telephone to the bystander. Every participant will perform closed-chest compression for 10 minutes on a slightly modified Resusci Anne® Manikin (Laerdal, Norway) without giving rescue breaths. Participants will be randomized to one of two groups: 1. Standard instructions will be given by the emergency medical dispatcher via telephone following the AMPDS protocol V12.0 provided by the IAED. 2. A smartphone with a prototype application transferring accelerometer data of the smartphone to a external webpage will be used to make CPR efforts immediately visible for the dispatcher in a remotely located dispatch center. Data will be collected using the Laerdal® PC Skill-Reporting System - a software used with the adult size Laerdal® Resusci® Anne SkillReporterTM manikin to collect the subjects' CPR performance.
Intervention type	Other
Primary outcome measure	Chest compression depth, measured continously via the pc skillmeter software of the Resusci® Anne skillmeter
Secondary outcome measures	1. Quality of External Cardiac Compression (ECC) defined as number of percent of adequately achieved compression depth, continuously assessed via skillmeter pc 2. Time to measurable decay in chest compression depth, continuously assessed via skillmeter pc 3. Frequency of chest compression, continuously assessed via skillmeter pc 4. Correct recoiling of the manikin's chest, continuously assessed via skillmeter pc
Overall study start date	01/07/2016
Completion date	31/12/2016

Eligibility

Participant type(s)	Healthy volunteer
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	24
Key inclusion criteria	1. Voluntary participants 2. Informed consent 3. Age over 18 years 4. Blood pressure less than 160 mmHg (systolic) before starting CPR simulation
Key exclusion criteria	1. Healthcare professionals 2. Basic Life Support course performed within the last 6 months 3. Pregnancy 4. Blood pressure over 150 mm Hg (systolic) before starting CPR simulation
Date of first enrolment	01/09/2016
Date of final enrolment	31/12/2016

Locations

Countries of recruitment

Austria

Study participating centres

Medical University of Vienna

Waehringerguertel 18-20/6D
Vienna
1090
Austria

St. Pölten University of Applied Science

Mathias-Corvinus Ring 15
St. Pölten
3100
Austria

Sponsor information

Medical University of Vienna (Austria)
University/education

Spitalgasse 23
Vienna
1090
Austria

Website	http://www.meduniwien.ac.at
"ROR"	https://ror.org/05n3x4p02

Funders

Funder type

Other

Investigator initiated and funded

No information available

Results and Publications

Intention to publish date	31/12/2017
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
Publication and dissemination plan	Results will be published in an emergency medicine journal.
IPD sharing plan

Editorial Notes

12/10/2017: internal review.