Basic Cardiac Life SupportNCT03690102

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

A study testing T-CPR and ERC standardized BLS course in people with Basic Cardiac Life Support and Cardiopulmonary Resuscitation, run by Copenhagen Academy for Medical Education and Simulation at 1 site in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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). Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Basic Cardiac Life Support, Cardiopulmonary Resuscitation
What is being tested?: T-CPR and ERC standardized BLS course
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 153 participants
Where: 1 siteDenmark
Study dates: 30 Sep 2018to 23 Aug 2020
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

Denmark1 site

Student2Student
Copenhagen, 2200

Other trials in Denmark

About this study

Official title: The Effect of Telephone Assistance on the Quality of Cardiopulmonary Resuscitation and Use of Automated External Defibrillator.

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.

Read the 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.

Conditions: Basic Cardiac Life Support, Cardiopulmonary Resuscitation
Being tested: T-CPR, ERC standardized BLS course

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT03690102
Study group	Role	What they receive
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. Receives: 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. Receives: 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. Receives: Other: T-CPR; Other: ERC standardized BLS course

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 8 minutes
Shock delivered
Shock delivered with AED (yes/no). Assessed by ERC instructor.
Measured: 8 minutes

Secondary outcomes (15)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

30 Sep 201823 Aug 2020

First posted1 Oct 2018
Study start30 Sep 2018
Primary completion23 Aug 2020
Study completion23 Aug 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Basic Cardiac Life SupportStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
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.
Masking: None (open label)
Enrolment: 153 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03690102
Sponsor's protocol ID: CAMES/AkutBeredskabet_2018_001
Status last verified: Feb 2021
First submitted: 26 Sep 2018
Last updated: 23 Feb 2021
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
Compression-Only Versus Standard Basic Life Support Training in Nursing Students
Cardiopulmonary Resuscitation, Out-of-Hospital Cardiac Arrest
Active, not recruiting
The REVIVE-PEEP Trial: Positive End-expiratory Pressure Versus Sham Valve/Zero End-expiratory Pressure in Cardiopulmonary Resuscitation During Manual Ventilation to Improve Neurological Outcomes at Discharge in Adult Patients Suffering an Out-of-hospital Cardiac Arrest
Cardiac Arrest, Out-Of-Hospital
Not yet recruiting
Generative AI and Gamified Simulation-Based Train-the-Trainer Basic Life Support Training for High School Teachers in Vietnam
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Effects of Two-Tier Test-Based Virtual Reality Instruction on ACLS Outcomes Among Clinical Nurses
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Active, not recruiting
The Effect of Virtual Reality-Assisted Escape Room Experience
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All Basic Cardiac Life Support trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Effect of Telephone Assistance on the Quality of Cardiopulmonary Resuscitation and Use of Automated External Defibrillator.
ClinicalTrials.gov ID: NCT03690102
Acronym / sponsor ID: CAMES/AkutBeredskabet_2018_001
Conditions: Basic Cardiac Life Support, Cardiopulmonary Resuscitation
Study type: Interventional
Recruitment status: Completed
Enrolment: 153 participants (actual)
Lead sponsor: Copenhagen Academy for Medical Education and SimulationUniversity, hospital or other
Collaborators: TrygFonden, Denmark, Emergency Medical Services, Capital Region, Denmark, University of Southern Denmark
Study start: 30 Sep 2018 (actual)
Primary completion: 23 Aug 2020 (actual)
Study completion: 23 Aug 2020 (actual)
First posted: 1 Oct 2018 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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 design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3
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.

Arm	Type	Receives
No BLS course. With T-CPR.	Experimental	Other: T-CPRThe 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.
With BLS course. No T-CPR.	Experimental	Other: ERC standardized BLS courseThe 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.
With BLS course. With T-CPR.	Experimental	Other: T-CPR, Other: ERC standardized BLS courseThe 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

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.

Key exclusion criteria (5 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
T-CPRParticipants receive telephone instructions in cardiopulmonary resuscitation (T-CPR) from the Emergency Medical Services in Copenhagen during the cardiac arrest scenario test.	Other	No BLS course. With T-CPR., With BLS course. With T-CPR.
ERC standardized BLS courseParticipants will receive and complete the standardized course in basic life support (BLS) from European Resuscitation Council (ERC).	Other	With BLS course. No T-CPR., With BLS course. With T-CPR.

Primary outcome

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.
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.
Shock delivered
Time frame: 8 minutes
Shock delivered with AED (yes/no). Assessed by ERC instructor.

15 secondary outcomes

Hands-of time
Time frame: 8 minutes
Responsiveness
Time frame: 8 minutes
Open airway
Time frame: 8 minutes
Assess breathing
Time frame: 8 minutes
Recoil/lean
Time frame: 8 minutes
Rescue breaths
Time frame: 8 minutes
Ratio
Time frame: 8 minutes
Activate AED
Time frame: 8 minutes
Attachment of AED pads
Time frame: 8 minutes
Stand clear
Time frame: 8 minutes
Compression depth 2
Time frame: 8 minutes
Compression rate 2
Time frame: 8 minutes
Rescue breaths 2
Time frame: 8 minutes
Time to first compression
Time frame: 8 minutes
Hand placement
Time frame: 8 minutes

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2021.
Individual participant dataSharing planned: No

Related trials for Basic Cardiac Life Support

Not yet recruiting
Compression-Only Versus Standard Basic Life Support Training in Nursing Students
Cardiopulmonary Resuscitation, Out-of-Hospital Cardiac Arrest
Active, not recruiting
The REVIVE-PEEP Trial: Positive End-expiratory Pressure Versus Sham Valve/Zero End-expiratory Pressure in Cardiopulmonary Resuscitation During Manual Ventilation to Improve Neurological Outcomes at Discharge in Adult Patients Suffering an Out-of-hospital Cardiac Arrest
Cardiac Arrest, Out-Of-Hospital
Not yet recruiting
Generative AI and Gamified Simulation-Based Train-the-Trainer Basic Life Support Training for High School Teachers in Vietnam
Cardiac Arrest, Cardiopulmonary Resuscitation
Not yet recruiting
Effects of Two-Tier Test-Based Virtual Reality Instruction on ACLS Outcomes Among Clinical Nurses
Advanced Cardiac Life Support Education
Active, not recruiting
The Effect of Virtual Reality-Assisted Escape Room Experience
Cardiac Arrest (CA)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Freddy Lippert study director

Emergency Medical Services, Capital Region, Denmark

Doris Oestergaard study director

Copenhagen Academy for Medical Education and Simulation

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Compression depth (time frame: 8 minutes). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03690102.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2021.