- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03690102
The Effect of T-CPR on the Quality of CPR and AED Use
The Effect of Telephone Assistance on the Quality of Cardiopulmonary Resuscitation and Use of Automated External Defibrillator.
The purpose of the study is to examine the effect of telephone assistance and standardized basic life support courses on the quality of cardiopulmonary resuscitation (CPR) and the use of automated external defibrillator (AED).
The investigators hypothesize that bystanders can provide compressions in correct frequency and use an AED correctly as well as safely from telephone instructions but that correct and successful ventilations including correct open airway require training on a course.
Study Overview
Status
Intervention / Treatment
Detailed Description
The study aims at answering the following research questions:
- How is the quality of CPR and use of AED when performed by an inexperienced bystander who receives telephone assistance compared to the quality when performed by a trained bystander, who has passed a standardized European Resuscitation Council (ERC) course in basic life support (BLS) but does not receive telephone assistance?
- How is the quality of CPR and use of AED when performed by a trained bystander who has passed a standardized ERC course in BLS and who receives telephone assistance compared to the quality when performed by a trained bystander who does not receive telephone assistance?
The questions are sought answered through simulated cardiac arrest scenarios in non-classroom settings.
Participants are recruited from ERC courses in BLS.
Participants are randomised to one of three groups (stratified for course type using computer-generated randomisation lists with blocks of variable sizes):
- Cardiac arrest scenario test before BLS course with telephone-assistance.
- Cardiac arrest scenario test after BLS course, no telephone-assistance.
- Cardiac arrest scenario test after BLS course with telephone-assistance.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Copenhagen, Denmark, 2200
- Student2Student
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Participant at a European Resuscitation Council standardized basic life support course. Participants are enrolled from courses for university students, courses for elderly and courses for recruits in the Danish Emergency Management Agency.
Exclusion Criteria:
- Basic life support course within the last two years.
- Healthcare professional or background as healthcare professional.
- Instructor in basic life support or first aid.
- Lifeguard or background as lifeguard.
- Does not want to participate.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: No BLS course. With T-CPR.
The participant is presented for a cardiac arrest scenario before attending the ERC standardized BLS course. During the scenario test, the participant will receive T-CPR. |
Participants receive telephone instructions in cardiopulmonary resuscitation (T-CPR) from the Emergency Medical Services in Copenhagen during the cardiac arrest scenario test.
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|
Experimental: With BLS course. No T-CPR.
The participant is presented for a cardiac arrest scenario after completion of the ERC standardized BLS course. During the scenario test, the participant will not receive T-CPR. |
Participants will receive and complete the standardized course in basic life support (BLS) from European Resuscitation Council (ERC).
|
|
Experimental: With BLS course. With T-CPR.
The participant is presented for a cardiac arrest scenario after completion of the ERC standardized BLS course. During the scenario test, the participant will receive T-CPR. |
Participants receive telephone instructions in cardiopulmonary resuscitation (T-CPR) from the Emergency Medical Services in Copenhagen during the cardiac arrest scenario test.
Participants will receive and complete the standardized course in basic life support (BLS) from European Resuscitation Council (ERC).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Compression depth
Time Frame: 8 minutes
|
Keeps a compression depth as recommended by International Liaison Committee on Resuscitation (ILCOR) (5-6 cm) on at least 50 % of compressions (yes/no).
Measured by advanced manikin.
|
8 minutes
|
|
Compression rate
Time Frame: 8 minutes
|
Rescuer keeps a compression rate of approximately 100-120 compressions per min.
throughout the CPR (yes/no).
Measured by advanced manikin.
|
8 minutes
|
|
Shock delivered
Time Frame: 8 minutes
|
Shock delivered with AED (yes/no).
Assessed by ERC instructor.
|
8 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Hands-of time
Time Frame: 8 minutes
|
Relevant actions of resuscitation within more than 75 % of the test time (yes/no).
Measured as no flow time by advanced manikin.
|
8 minutes
|
|
Responsiveness
Time Frame: 8 minutes
|
Shakes AND shouts (yes/no).
Assessed by ERC instructor.
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8 minutes
|
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Open airway
Time Frame: 8 minutes
|
Opens or correctly tries to open mouth (chin lift OR jaw thrust) (yes/no).
Assessed by ERC instructor.
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8 minutes
|
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Assess breathing
Time Frame: 8 minutes
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Looks, listens AND feels for normal breathing (yes/no).
Assessed by ERC instructor.
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8 minutes
|
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Recoil/lean
Time Frame: 8 minutes
|
Full rise on at least 50 % of all compressions (yes/no).
Measured by advanced manikin.
|
8 minutes
|
|
Rescue breaths
Time Frame: 8 minutes
|
More than 400 mL for at least 50 % of all ventilations (yes/no).
Measured by advanced manikin.
|
8 minutes
|
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Ratio
Time Frame: 8 minutes
|
Acceptable range 28-32:2 (yes/no).
Assessed by ERC instructor.
|
8 minutes
|
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Activate AED
Time Frame: 8 minutes
|
Activates AED immediately upon arrival (yes/no).
Assessed by ERC instructor.
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8 minutes
|
|
Attachment of AED pads
Time Frame: 8 minutes
|
Correct attachment of AED pads according to the picture in protocol (yes/no).
Assessed by ERC instructor.
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8 minutes
|
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Stand clear
Time Frame: 8 minutes
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Ensures safety by looking around and verbally announcing delivery of shock (yes/no).
Assessed by ERC instructor.
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8 minutes
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Compression depth 2
Time Frame: 8 minutes
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Percentage of compressions with a depth within the recommendations from ILCOR (5-6 cm) (%).
Measured by advanced manikin.
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8 minutes
|
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Compression rate 2
Time Frame: 8 minutes
|
Average rate of compressions (compressions/minute).
Measured by advanced manikin.
|
8 minutes
|
|
Rescue breaths 2
Time Frame: 8 minutes
|
Percentage of ventilations with more than 400 mL (%).
Measured by advanced manikin.
|
8 minutes
|
|
Time to first compression
Time Frame: 8 minutes
|
Time from scenario start to first compression.
Assessed by ERC instructor.
|
8 minutes
|
|
Hand placement
Time Frame: 8 minutes
|
Correct hand placement in at least 50 % of compressions (yes/no).
Measured by advanced manikin.
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8 minutes
|
Collaborators and Investigators
Collaborators
Investigators
- Study Director: Freddy Lippert, Emergency Medical Services, Capital Region, Denmark
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- CAMES/AkutBeredskabet_2018_001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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