NCT03690102

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
153

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 26, 2018

Completed
4 days until next milestone

Study Start

First participant enrolled

September 30, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 1, 2018

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 23, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 23, 2020

Completed
Last Updated

February 23, 2021

Status Verified

February 1, 2021

Enrollment Period

1.9 years

First QC Date

September 26, 2018

Last Update Submit

February 20, 2021

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • Shock delivered

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

    8 minutes

Secondary Outcomes (15)

  • Hands-of time

    8 minutes

  • Responsiveness

    8 minutes

  • Open airway

    8 minutes

  • Assess breathing

    8 minutes

  • Recoil/lean

    8 minutes

  • +10 more secondary outcomes

Study Arms (3)

No BLS course. With T-CPR.

EXPERIMENTAL

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

With BLS course. No T-CPR.

EXPERIMENTAL

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

With BLS course. With T-CPR.

EXPERIMENTAL

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-CPROther: ERC standardized BLS course

Interventions

T-CPROTHER

Participants receive telephone instructions in cardiopulmonary resuscitation (T-CPR) from the Emergency Medical Services in Copenhagen during the cardiac arrest scenario test.

No BLS course. With T-CPR.With BLS course. With T-CPR.

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

With BLS course. No T-CPR.With BLS course. With T-CPR.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Student2Student

Copenhagen, 2200, Denmark

Location

Study Officials

  • Freddy Lippert

    Emergency Medical Services, Capital Region, Denmark

    STUDY DIRECTOR
  • Doris Oestergaard

    Copenhagen Academy for Medical Education and Simulation

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Researcher, medical student

Study Record Dates

First Submitted

September 26, 2018

First Posted

October 1, 2018

Study Start

September 30, 2018

Primary Completion

August 23, 2020

Study Completion

August 23, 2020

Last Updated

February 23, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations