Compression Only CardioPulmonary Resuscitation in telephone assisted bystanders

ISRCTN	ISRCTN51784217
DOI	https://doi.org/10.1186/ISRCTN51784217
Secondary identifying numbers	V1.4

Submission date: 23/01/2011
Registration date: 08/02/2011
Last edited: 08/02/2011

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Other

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Raphael van Tulder
Scientific

Department of Emergency Medicine
Medical University Vienna
General Hospital Vienna
Waehringerguertel 18-20/ 6D
Vienna
1090
Austria

Phone	+43 (0)1 40400 1964
Email	raphael.van-tulder@meduniwien.ac.at

Study information

Study design	Randomised parallel group simulation study
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Other
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
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
Study acronym	COCPR
Study objectives	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(s)	Ethics Committee of the Medical University of Vienna approved on the 11th January 2011
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	03/03/2011
Completion date	03/03/2011

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	24
Key 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
Key exclusion criteria	1. Health care professionals 2. Pregnancy 3. Blood pressure greater than 150 mmHg (systolic) before CPR simulation
Date of first enrolment	03/03/2011
Date of final enrolment	03/03/2011

Locations

Countries of recruitment

Austria

Study participating centre

Department of Emergency Medicine

Vienna
1090
Austria

Sponsor information

Individual Sponsor (Austria)
Other

c/o Associate Professor Harald Herkner, MD, MSc
Clinical Epidemiologist
Department of Emergency Medicine
Waehringer Guertel 18-20
Vienna
1090
Austria

Phone	+43 (0)1 40400 1964
Email	harald.herkner@meduniwien.ac.at
Website	http://www.meduniwien.ac.at/notfall

Funders

Funder type

Industry

RORACO GmBH (Austria)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan