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
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
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
31/12/2017
Participant level data
Available on request
Results - basic reporting
Publication summary