Condition category
Signs and Symptoms
Date applied
20/03/2012
Date assigned
28/03/2012
Last edited
13/01/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims:
High quality chest compressions are vital for neurologically intact survival after cardiac arrest. Therefore bystanders are encouraged to act decisively in presence of a cardiac arrest victim. For this case, protocol based, telephone instructions for chest compressions are given by emergency dispatchers responding to emergency calls. Unfortunately quality of chest compression remains suboptimal which is understandable because bystanders are usually untrained. The aim of this study is to improve quality of chest compression by adapting telephone instructions.

Who can participate?
Your participation is voluntary. You need to be older than 18 years, give an informed consent and your blood pressure should be less than 150 mm Hg before the study starts.

What does the study involve?
We will compare a slightly adapted verbal instruction to the standard protocol based instruction set for telephone resuscitation.
If you take part two questionnaires are requested. The first one targets demographic data’s such as age, smoking habits etc. The second questionnaire evaluates your physical fitness. Afterwards, you are requested to perform a skill test evaluating fine motor skills. For this test you need to put pegs into holes with your non-dominant hand. Before the study starts your blood pressure and your heart frequency is measured.

The main study is a simulated, 10 minute, cardiopulmonary resuscitation on a manikin with human like properties. The study scenario stipulates that you are confronted with a cardiac arrest victim at home. Via telephone, a professional emergency dispatcher, will give you verbal instructions how to resuscitate the victim. The resuscitation is performed as a chest compressions only resuscitation. During the resuscitation we will ask you for your subjective perceived exertion. After you have finished the simulated resuscitation scenario we will measure your heart rate and your blood pressure again. Also, you are requested to redo the skill test.

What are the possible benefits and risks of participating?
We expect no risk for your health caused by this study. Your personal benefit will be a renewal of your basic life support skills.

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. Verbal instructions are given by a professional emergency dispatcher who will be situated in an emergency dispatch centre.

When is study starting and how long is it expected to run for?
This study will be performed on June, 27th 2012. Your participation will take only 15 minutes.

Who is funding the study?
The study is being funded by RORACO which will provide the Laerdal resusci anne manikin.

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

Contact details

Medical University of Vienna
Department of Emergency Medicine
Waehringerguertel 18-20/6D
Vienna
1090
Austria
+43-1-40400-1964
raphael.van-tulder@meduniwien.ac.at

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

V1.1

Study information

Scientific title

Is repeating the target depth instruction improving overall compression depth in an Advanced Medical Priority Dispatch System (AMPDS) guided, telephone compression only cardiopulmonary resuscitation? A randomized factorial simulation study

Acronym

COCPR II

Study hypothesis

Please note that, as of 11/05/2012, the scientific title of this trial has been changed from 'Is repeating the target depth instruction every minute improving overall compression depth in an Advanced Medical Priority Dispatch System (AMPDS) guided, telephone compression only cardiopulmonary resuscitation? A randomized parallel group simulation study' to 'Is repeating the target depth instruction improving overall compression depth in an Advanced Medical Priority Dispatch System (AMPDS) guided, telephone compression only cardiopulmonary resuscitation? A randomized factorial simulation study'

As os 11/05/2012, the study design of this trial has been changed from 'Double-blinded randomized parallel group simulation study' to 'Double-blinded randomized factorial simulation study’

Repeating the telephone instruction “push down firmly 5 cm” improves overall compression depth.

Follow up of study registered under http://www.controlled-trials.com/ISRCTN51784217

Ethics approval

Ethical Committee of the Medical University of Vienna, 02 February 2012

Study design

Double-blinded randomized factorial simulation study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

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

Condition

Cardiopulmonary resuscitation

Intervention

Current interventions as of 11/05/2012:

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 participant. 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. Study staffs assignment is documentation of parameters and not to be involved into bystander CPR.

Participants will be staffed with a telephone to call the Emergency Dispatch Center (EDC). In the EDC, a professional emergency dispatcher will be providing verbal prompts via telephone to the bystander. The EMD is randomised to give different instructions. Verbal prompts, given by the EMD, are following the AMPDS protocol V12.0.

According to the factorial design we intend to investigate changes in the AMPDS protocol as follows:

Group 1: Standard instruction: "push down firmly 5 cm"

Group 2: Push down the chest 5 cm every time” after initial directions

Group 3: like Group 2, but the instruction will be repeated every 20 seconds

Group 4: like Group 1, but the instruction “push down firmly 5cm” will be repeated every 20 seconds

The EMD has to open one opaque envelope per call to be randomised in either control or intervention. Therefore study staff are also blinded to allocation of the bystander.

Another predefined precondition is that all bystanders are denying rescue breaths. Every participant is performing closed-chest compression for 10 minutes on a slightly modified Resusci Anne® Manikin (Laerdal, Norway). 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.

Previous interventions:

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 participant. 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. Study staffs assignment is documentation of parameters and not to be involved into bystander CPR.

Participants will be staffed with a telephone to call the Emergency Dispatch Center (EDC). In the EDC, a professional emergency dispatcher will be providing verbal prompts via telephone to the bystander. The EMD is randomised to give two different instructions. Verbal prompts, given by the EMD, are following the AMPDS protocol V12.0.

For the control group the standard instruction "press down firmly 5 cms“ is given at the beginning of the simulated CPR scenario.

For the interventional group "press down fimrly 5 cm’s“ is repeated every minute.

The EMD has to open one opaque envelope per call to be randomised in either control or intervention. Therefore study staff are also blinded to allocation of the bystander.

Another predefined precondition is that all bystanders are denying rescue breaths. Every participant is performing closed-chest compression for 10 minutes on a slightly modified Resusci Anne® Manikin (Laerdal, Norway). 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

Not Applicable

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 ECC defined as number of percent of adequately achieved compression depth, continously assesed via skillmeter pc
2. Time to measurable decay in chest compression depth, continously assesed via skillmeter pc
3. Frequency of chest compression, continously assesed via skillmeter pc
4. Correct recoiling of the manikins chest, continously assesed via skillmeter pc
5. Heart rate/systolic blood pressure ratio reflecting physical strain, measured before and immediately after chest compression
6. BORG rate of perceived exertion measured at 2nd, 4th, 6th and 10th minute of chest compressions
7. Serum lactate changes
8. Systolic and diastolic blood pressure
9. Nine Hole Peg Test, measured before and immediately after chest compression

Overall trial start date

27/06/2012

Overall trial end date

27/06/2012

Reason abandoned

Eligibility

Participant inclusion criteria

1. Voluntary participants
2. Informed Consent
3. Aged greater than 18 years
4. Blood pressure less than 150 mm Hg (systolic) before starting CPR simulation

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

24

Participant exclusion criteria

1. Health care 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

27/06/2012

Recruitment end date

27/06/2012

Locations

Countries of recruitment

Austria

Trial participating centre

Medical University of Vienna
Vienna
1090
Austria

Sponsor information

Organisation

Medical University of Vienna (Austria)

Sponsor details

c/o Associate Prof. Dr. Harald Herkner
MSc
Clinical epidemiologist
Department of Emergency Medicine
Waehringerguertel 18-20/6D
Vienna
1090
Austria
+43 1 40400 1964
harald.herkner@meduniwien.ac.at

Sponsor type

Other

Website

http://www.meduniwien.ac.at/notfall

Funders

Funder type

Industry

Funder name

Roraco GmbH (Austria)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24012684

Publication citations

Additional files

Editorial Notes