Compression Only CardioPulmonary Resuscitation in telephone assisted bystanders (COCPR II)

ISRCTN ISRCTN85521420
DOI https://doi.org/10.1186/ISRCTN85521420
Secondary identifying numbers V1.1
Submission date
20/03/2012
Registration date
28/03/2012
Last edited
13/01/2015
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Signs and Symptoms
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

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

Contact information

Dr Raphael van Tulder
Scientific

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

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

Study information

Study designDouble-blinded randomized factorial simulation study
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Other
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleIs 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
Study acronymCOCPR II
Study objectivesPlease 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(s)Ethical Committee of the Medical University of Vienna, 02 February 2012
Health condition(s) or problem(s) studiedCardiopulmonary resuscitation
InterventionCurrent 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 typeOther
Primary outcome measureChest compression depth, measured continously via the pc skillmeter software of the resusci anne skillmeter
Secondary outcome measures1. 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 date27/06/2012
Completion date27/06/2012

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants24
Key inclusion criteria1. Voluntary participants
2. Informed Consent
3. Aged greater than 18 years
4. Blood pressure less than 150 mm Hg (systolic) before starting CPR simulation
Key exclusion criteria1. 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
Date of first enrolment27/06/2012
Date of final enrolment27/06/2012

Locations

Countries of recruitment

  • Austria

Study participating centre

Medical University of Vienna
Vienna
1090
Austria

Sponsor information

Medical University of Vienna (Austria)
Other

c/o Associate Prof. Dr. Harald Herkner, MSc
Clinical epidemiologist
Department of Emergency Medicine
Waehringerguertel 18-20/6D
Vienna
1090
Austria

Phone +43 1 40400 1964
Email harald.herkner@meduniwien.ac.at
Website http://www.meduniwien.ac.at/notfall
ROR logo "ROR" https://ror.org/05n3x4p02

Funders

Funder type

Industry

Roraco GmbH (Austria)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/01/2014 Yes No