The Effect of T-CPR on the Quality of CPR and AED Use

Sponsor
Copenhagen Academy for Medical Education and Simulation (Other)
Overall Status
Completed
CT.gov ID
NCT03690102
Collaborator
TrygFonden, Denmark (Industry), Emergency Medical Services, Capital Region, Denmark (Other), University of Southern Denmark (Other)
153
1
3
22.8
6.7

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Other: T-CPR
  • Other: ERC standardized BLS course
N/A

Detailed 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.

Study Design

Study Type:
Interventional
Actual Enrollment :
153 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Parallel Assignment Participants are randomized to one of three groups (stratified for course type, using computer-generated lists with variable block sizes): Participants are given a cardiac arrest scenario test either before or after a European Resuscitation Council standardized basic life support course. Two of the groups receive instructions in cardiopulmonary resuscitation from a dispatcher when they call the Emergency Medical Services.Parallel AssignmentParticipants are randomized to one of three groups (stratified for course type, using computer-generated lists with variable block sizes):Participants are given a cardiac arrest scenario test either before or after a European Resuscitation Council standardized basic life support course. Two of the groups receive instructions in cardiopulmonary resuscitation from a dispatcher when they call the Emergency Medical Services.
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
The Effect of Telephone Assistance on the Quality of Cardiopulmonary Resuscitation and Use of Automated External Defibrillator.
Actual Study Start Date :
Sep 30, 2018
Actual Primary Completion Date :
Aug 23, 2020
Actual Study Completion Date :
Aug 23, 2020

Arms and Interventions

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.

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.

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.

Other: ERC standardized BLS course
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.

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.

Other: ERC standardized BLS course
Participants will receive and complete the standardized course in basic life support (BLS) from European Resuscitation Council (ERC).

Outcome Measures

Primary Outcome Measures

  1. Compression depth [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.

  2. Compression rate [8 minutes]

    Rescuer keeps a compression rate of approximately 100-120 compressions per min. throughout the CPR (yes/no). Measured by advanced manikin.

  3. Shock delivered [8 minutes]

    Shock delivered with AED (yes/no). Assessed by ERC instructor.

Secondary Outcome Measures

  1. Hands-of time [8 minutes]

    Relevant actions of resuscitation within more than 75 % of the test time (yes/no). Measured as no flow time by advanced manikin.

  2. Responsiveness [8 minutes]

    Shakes AND shouts (yes/no). Assessed by ERC instructor.

  3. Open airway [8 minutes]

    Opens or correctly tries to open mouth (chin lift OR jaw thrust) (yes/no). Assessed by ERC instructor.

  4. Assess breathing [8 minutes]

    Looks, listens AND feels for normal breathing (yes/no). Assessed by ERC instructor.

  5. Recoil/lean [8 minutes]

    Full rise on at least 50 % of all compressions (yes/no). Measured by advanced manikin.

  6. Rescue breaths [8 minutes]

    More than 400 mL for at least 50 % of all ventilations (yes/no). Measured by advanced manikin.

  7. Ratio [8 minutes]

    Acceptable range 28-32:2 (yes/no). Assessed by ERC instructor.

  8. Activate AED [8 minutes]

    Activates AED immediately upon arrival (yes/no). Assessed by ERC instructor.

  9. Attachment of AED pads [8 minutes]

    Correct attachment of AED pads according to the picture in protocol (yes/no). Assessed by ERC instructor.

  10. Stand clear [8 minutes]

    Ensures safety by looking around and verbally announcing delivery of shock (yes/no). Assessed by ERC instructor.

  11. Compression depth 2 [8 minutes]

    Percentage of compressions with a depth within the recommendations from ILCOR (5-6 cm) (%). Measured by advanced manikin.

  12. Compression rate 2 [8 minutes]

    Average rate of compressions (compressions/minute). Measured by advanced manikin.

  13. Rescue breaths 2 [8 minutes]

    Percentage of ventilations with more than 400 mL (%). Measured by advanced manikin.

  14. Time to first compression [8 minutes]

    Time from scenario start to first compression. Assessed by ERC instructor.

  15. Hand placement [8 minutes]

    Correct hand placement in at least 50 % of compressions (yes/no). Measured by advanced manikin.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Student2Student Copenhagen Denmark 2200

Sponsors and Collaborators

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

Investigators

  • Study Director: Freddy Lippert, Emergency Medical Services, Capital Region, Denmark
  • Study Director: Doris Oestergaard, Copenhagen Academy for Medical Education and Simulation

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Kristine Elisabeth Eberhard, Researcher, medical student, Copenhagen Academy for Medical Education and Simulation
ClinicalTrials.gov Identifier:
NCT03690102
Other Study ID Numbers:
  • CAMES/AkutBeredskabet_2018_001
First Posted:
Oct 1, 2018
Last Update Posted:
Feb 23, 2021
Last Verified:
Feb 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Feb 23, 2021