Condition category
Circulatory System
Date applied
07/07/2016
Date assigned
09/07/2016
Last edited
08/07/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

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

Trial website

http://lifestream.fhstp.ac.at

Contact information

Type

Scientific

Primary contact

Dr Raphael van Tulder

ORCID ID

http://orcid.org/0000-0002-0929-8988

Contact details

Waehringerguertel 18-20/6D
Vienna
1090
Austria
+43 (0)140 4001 9640
Raphael.van-tulder@meduniwien.ac.at

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

V1

Study information

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

Acronym

COCPR IV

Study hypothesis

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

The ethics committee of the Medical University of Vienna, 21/03/2016, ref: 1103/2016

Study design

Prospective randomized-controlled simulation trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Community

Trial type

Other

Patient information sheet

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

Condition

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

Phase

Drug names

Primary outcome measures

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 trial start date

01/07/2016

Overall trial end date

31/12/2016

Reason abandoned

Eligibility

Participant 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

Participant type

Healthy volunteer

Age group

Adult

Gender

Both

Target number of participants

24

Participant 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

Recruitment start date

01/09/2016

Recruitment end date

31/12/2016

Locations

Countries of recruitment

Austria

Trial participating centre

Medical University of Vienna
Waehringerguertel 18-20/6D
Vienna
1090
Austria

Trial participating centre

St. Pölten University of Applied Science
Mathias-Corvinus Ring 15
St. Pölten
3100
Austria

Sponsor information

Organisation

Medical University of Vienna (Austria)

Sponsor details

Spitalgasse 23
Vienna
1090
Austria

Sponsor type

University/education

Website

http://www.meduniwien.ac.at

Funders

Funder type

Other

Funder name

Investigator initiated and funded

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Results will be published in an emergency medicine journal.

Intention to publish date

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes