Condition category
Not Applicable
Date applied
23/01/2011
Date assigned
08/02/2011
Last edited
08/02/2011
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Raphael van Tulder

ORCID ID

Contact details

Department of Emergency Medicine
Medical University Vienna
General Hospital Vienna
Waehringerguertel 18-20/ 6D
Vienna
1090
Austria
+43 (0)1 40400 1964
raphael.van-tulder@meduniwien.ac.at

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

V1.4

Study information

Scientific title

Compression Only CardioPulmonary Resuscitation CPR (COCPR) in telephone assisted bystanders: is "to push hard as you can", superior in achieving 5 - 6 cm chest compression depth than the current guideline recommendation? A randomised parallel-group simulation study

Acronym

COCPR

Study hypothesis

Recommending to "push hard as you can" in adult cardiopulmonary resuscitation (CPR) is more effective to reach target depth of 5 - 6 cm.

Ethics approval

Ethics Committee of the Medical University of Vienna approved on the 11th January 2011

Study design

Randomised parallel group 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

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 verbal commands: "compress with 5 cm" or "push as hard as you can". 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.

Verbal prompts, given by the EMD, are following the AMPDS protocol V12.0 for control, advising to "push 5 cm".

For the intervention a slightly adopted AMPDS protocol will be advising "push as hard as you can". No other changes will be made onto the protocol.

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

03/03/2011

Overall trial end date

03/03/2011

Reason abandoned

Eligibility

Participant inclusion criteria

1. Voluntary participants, first aid course completed or not
2. Informed consent
3. Aged greater than 18 years
4. Blood pressure less than 150 mmHg before starting CPR

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

24

Participant exclusion criteria

1. Health care professionals
2. Pregnancy
3. Blood pressure greater than 150 mmHg (systolic) before CPR simulation

Recruitment start date

03/03/2011

Recruitment end date

03/03/2011

Locations

Countries of recruitment

Austria

Trial participating centre

Department of Emergency Medicine
Vienna
1090
Austria

Sponsor information

Organisation

Individual Sponsor (Austria)

Sponsor details

c/o Associate Professor Harald Herkner
MD
MSc
Clinical Epidemiologist
Department of Emergency Medicine
Waehringer Guertel 18-20
Vienna
1090
Austria
+43 (0)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

Publication citations

Additional files

Editorial Notes