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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03690102
Other study ID # CAMES/AkutBeredskabet_2018_001
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 30, 2018
Est. completion date August 23, 2020

Study information

Verified date February 2021
Source Copenhagen Academy for Medical Education and Simulation
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

The study aims at answering the following research questions: 1. 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? 2. 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): 1. Cardiac arrest scenario test before BLS course with telephone-assistance. 2. Cardiac arrest scenario test after BLS course, no telephone-assistance. 3. Cardiac arrest scenario test after BLS course with telephone-assistance.


Recruitment information / eligibility

Status Completed
Enrollment 153
Est. completion date August 23, 2020
Est. primary completion date August 23, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Intervention

Other:
T-CPR
Participants receive telephone instructions in cardiopulmonary resuscitation (T-CPR) from the Emergency Medical Services in Copenhagen during the cardiac arrest scenario test.
ERC standardized BLS course
Participants will receive and complete the standardized course in basic life support (BLS) from European Resuscitation Council (ERC).

Locations

Country Name City State
Denmark Student2Student Copenhagen

Sponsors (4)

Lead Sponsor Collaborator
Copenhagen Academy for Medical Education and Simulation Emergency Medical Services, Capital Region, Denmark, TrygFonden, Denmark, University of Southern Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary Compression depth 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
Primary Compression rate Rescuer keeps a compression rate of approximately 100-120 compressions per min. throughout the CPR (yes/no). Measured by advanced manikin. 8 minutes
Primary Shock delivered Shock delivered with AED (yes/no). Assessed by ERC instructor. 8 minutes
Secondary Hands-of time Relevant actions of resuscitation within more than 75 % of the test time (yes/no). Measured as no flow time by advanced manikin. 8 minutes
Secondary Responsiveness Shakes AND shouts (yes/no). Assessed by ERC instructor. 8 minutes
Secondary Open airway Opens or correctly tries to open mouth (chin lift OR jaw thrust) (yes/no). Assessed by ERC instructor. 8 minutes
Secondary Assess breathing Looks, listens AND feels for normal breathing (yes/no). Assessed by ERC instructor. 8 minutes
Secondary Recoil/lean Full rise on at least 50 % of all compressions (yes/no). Measured by advanced manikin. 8 minutes
Secondary Rescue breaths More than 400 mL for at least 50 % of all ventilations (yes/no). Measured by advanced manikin. 8 minutes
Secondary Ratio Acceptable range 28-32:2 (yes/no). Assessed by ERC instructor. 8 minutes
Secondary Activate AED Activates AED immediately upon arrival (yes/no). Assessed by ERC instructor. 8 minutes
Secondary Attachment of AED pads Correct attachment of AED pads according to the picture in protocol (yes/no). Assessed by ERC instructor. 8 minutes
Secondary Stand clear Ensures safety by looking around and verbally announcing delivery of shock (yes/no). Assessed by ERC instructor. 8 minutes
Secondary Compression depth 2 Percentage of compressions with a depth within the recommendations from ILCOR (5-6 cm) (%). Measured by advanced manikin. 8 minutes
Secondary Compression rate 2 Average rate of compressions (compressions/minute). Measured by advanced manikin. 8 minutes
Secondary Rescue breaths 2 Percentage of ventilations with more than 400 mL (%). Measured by advanced manikin. 8 minutes
Secondary Time to first compression Time from scenario start to first compression. Assessed by ERC instructor. 8 minutes
Secondary Hand placement Correct hand placement in at least 50 % of compressions (yes/no). Measured by advanced manikin. 8 minutes
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