- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07520877
Effect of AED-optimized Telephone-assisted CPR Instructions on No-flow Time and Chest Compression Fraction
Effect of AED-optimized Telephone-assisted CPR Instructions on No-flow Time and Chest Compression Fraction in a Single-rescuer Cardiac Arrest Scenario - a Randomized-controlled Simulation Study
Out-of-hospital cardiac arrest (OHCA) remains a leading cause of mortality worldwide, with survival highly dependent on the immediate initiation of bystander cardiopulmonary resuscitation (CPR). Early recognition, prompt chest compressions, and rapid defibrillation are critical components of the chain of survival. Telephone-assisted CPR (T-CPR) provided by emergency dispatchers has been shown to significantly increase bystander intervention rates and improve outcomes. While the availability and use of automated external defibrillators (AEDs) further enhance survival, the optimal integration of AED use into dispatcher-guided, single-rescuer scenarios remains insufficiently studied.
This prospective, randomized, controlled simulation study aims to evaluate the effect of modified telephone cardiopulmonary resuscitation (T-CPR) instructions optimized for automated external defibrillator (AED) use on no-flow time and chest compression fraction (CCF) during single-rescuer resuscitation. Participants are randomized to receive either standard T-CPR instructions or enhanced instructions focusing on minimizing interruptions in chest compressions and reducing time to first compression during AED use.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Out-of-hospital cardiac arrest (OHCA) is a major public health problem associated with low survival rates despite advances in emergency care systems. Survival is critically dependent on early recognition, immediate initiation of high-quality chest compressions, and timely defibrillation. Bystander intervention plays a pivotal role in this process, and telephone-assisted cardiopulmonary resuscitation (T-CPR) has been demonstrated to substantially increase the likelihood of CPR initiation prior to the arrival of emergency medical services.
The increasing availability of automated external defibrillators (AEDs) in public spaces has further strengthened the chain of survival. Early defibrillation is a key determinant of favorable outcomes, particularly in shockable rhythms. However, the integration of AED use into dispatcher-assisted scenarios - especially when only a single rescuer is present - poses practical challenges. In such situations, the rescuer must balance multiple tasks, including chest compressions, AED retrieval, device preparation, and adherence to voice prompts, all of which may introduce interruptions in compressions and increase no-flow time.
While the benefits of T-CPR and AED use independently are well established, there is limited evidence on how dispatcher instructions can optimally coordinate these interventions in single-rescuer scenarios. In particular, it remains unclear whether modified, AED-optimized T-CPR instructions can reduce no-flow time and improve chest compression fraction (CCF) by minimizing unnecessary interruptions and optimizing task sequencing.
This prospective, randomized, controlled simulation study aims to evaluate the effect of modified telephone cardiopulmonary resuscitation (T-CPR) instructions optimized for automated external defibrillator (AED) use on no-flow time and chest compression fraction (CCF) during single-rescuer resuscitation. Participants are randomized to receive either standard T-CPR instructions or enhanced instructions focusing on minimizing interruptions in chest compressions and reducing time to first compression during AED use.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Bálint Bánfai, Ph.D.
- Phone Number: +3630501500
- Email: balint.banfai@etk.pte.hu
Study Locations
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-
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Pécs, Hungary, 7621
- Recruiting
- University of Pecs
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Contact:
- Bálint Bánfai, Ph.D.
- Phone Number: +3672501500
- Email: balint.banfai@etk.pte.hu
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Adolescents and adults (≥16 years)
- Healthcare professionals or laypersons
- Voluntary participation
Exclusion Criteria:
- pregnant women
- people with cardio-pulmonary and musculoskeletal diseases or any other impairment that would risk harm for the volunteer while performing CPR
- physical and/or psychological disabilities
- technical issue during data collection
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Standard T-CPR
Participants perform dispatcher-assisted CPR based on the European Resuscitation Council (ERC) 2025 guidelines and the national standard DA-CPR protocol.
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Participants receive structured telephone CPR instructions reflecting current national practice.
AED retrieval is instructed early; however, no additional guidance is provided to optimize timing or minimize interruptions during AED use.
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Active Comparator: AED-optimized T-CPR
Participants perform dispatcher-assisted CPR based on the European Resuscitation Council (ERC) 2025 guidelines and a modified national DA-CPR protocol.
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Participants receive standard T-CPR instructions supplemented with specific guidance aimed at:
Key elements include:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
No-flow time
Time Frame: During procedure.
|
Time without chest compressions measured from entry into the simulation (collapse recognition) until termination of the scenario (giving the third shock).
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During procedure.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Time to first chest compression
Time Frame: During procedure.
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The time (in seconds) until the first chest compression (measured from entering the scenario).
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During procedure.
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Time to first shock
Time Frame: During procedure
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The time to the first shock by the AED (in seconds, from the time of entering the scenario).
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During procedure
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Chest compression fraction
Time Frame: During procedure.
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Proportion of time during which chest compressions are performed (until giving the third shock), calculated from the first chest compression until scenario termination.
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During procedure.
|
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Peri-shock pause
Time Frame: During procedure
|
The time without chest compression (in seconds) before and after giving the shock.
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During procedure
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Attitude about T-CPR instructions
Time Frame: Immediately after the CPR procedure (within 15 minutes)
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Subjective feelings after performing cardiopulmonary resuscitation based on a short survey using Likert-scale based queries (1-4 points, lower numbers indicate worse, higher score indicates better opinion).
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Immediately after the CPR procedure (within 15 minutes)
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- DA-CPR and AED
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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