- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05908500
Gathering Evidence on Best Practices for Lay Rescuer CPR Training
Generating Evidence to Optimize Lay Rescuer Cardiopulmonary Resuscitation (CPR) Training: a Longitudinal Study of Frequency, Modality, and Design Features Impacting Skill Retention
The goal of this prospective trial is to compare CPR skill and attitudes in lay rescuers. The main question[s] it aims to answer are:
- What is the optimal training timing, duration, and frequency for lay rescuers that leads to CPR skill retention?
- What is the impact of CPR manikin type (high-fidelity, inflatable, nontraditional objects) on skill retention?
- How do specific features of training modality -- such as contextualization, gamification, and emotional engagement -- impact skill proficiency, knowledge retention, and attitudes about CPR?
Participants will
- Answer pre-training questionnaires
- Participate in CPR training
- Participate in CPR skills testing
- Answer post-training questionnaires
Researchers will compare different methods of training, different frequencies of training, and different manikin types.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Out-of-hospital cardiac arrest (OHCA) remains a major public health crisis in the United States, with over 350,000 cases annually and low survival rates. Lay rescuer cardiopulmonary resuscitation (CPR) can double survival, yet widespread gaps in training access, skill retention, and emotional readiness persist. While most U.S. states mandate high school CPR training, implementation quality varies, and traditional formats have remained unchanged for over 60 years. These methods are often time-consuming, expensive, and poorly suited for adolescents, leading to low participation and rapid skill decay.
This study addresses these critical gaps by comparing various CPR training methods and procedures. The project tests the effectiveness of different training frequencies, durations, and delivery modes-including traditional instructor-led sessions, brief refreshers, and a novel, emotionally immersive serious game. The serious game leverages gamification, competition, and scenario-based learning to build "emotional muscle memory" and prepare students for real-world emergencies.
Participants are enrolled from two high schools-one rural, one suburban-and randomized by class or individual into training arms with varied schedules and compression practice tools. These tools range from high-fidelity manikins to low-fidelity devices and improvised household objects. Outcomes include CPR performance metrics (compression rate, depth, recoil, and hand placement), knowledge retention, emotional engagement (measured via validated psychometric scales), and confidence in responding to cardiac arrest.
Training sessions are delivered during the academic year, and students are assessed immediately after training and again at annual follow-up points. Data are collected in a de-identified format using school-issued ID numbers, ensuring participant confidentiality. Analysis will use generalized estimating equations and mixed-effects models to assess the impact of training method and frequency on skill retention and psychosocial readiness. The study also explores the role of contextualization, emotional engagement, and gamification as mediators of improved CPR performance.
Ultimately, this multi-year trial aims to identify scalable, cost-effective strategies that optimize CPR training outcomes for lay rescuers. By improving technical skill retention and emotional preparedness, the study addresses key priorities for public health impact and aligns with NHLBI's strategic goals to reduce mortality from sudden cardiac arrest.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Lorrel Toft, MD
- Phone Number: 4103028456
- Email: ltoft@unr.edu
Study Locations
-
-
Nevada
-
Reno, Nevada, United States, 89557
- University of Nevada Reno
-
Principal Investigator:
- Lorrel Toft, MD
-
Contact:
- Lorrel Toft
- Phone Number: 4103028456
- Email: ltoft@unr.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- All students at participating schools
Exclusion Criteria:
- Previous CPR training (will be included in the CPR training but excluded from analysis)
- Physical injury which prevents performing CPR
- Student or parent opt-out
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Every 2 year standard CPR training
Receives two 60-minute instructor-led CPR trainings: once in 9th grade and again in 11th grade
|
Various durations and frequencies of CPR training
|
|
Active Comparator: Annual Standard CPR training
Receives a 60-minute instructor-led CPR training each year for three years.
|
Various durations and frequencies of CPR training
|
|
Active Comparator: High-Frequency, Blended Training
Starts with a 30-minute serious game-based session, followed by 10-minute refreshers every semester for four years (8 total sessions).
|
Various durations and frequencies of CPR training
|
|
Active Comparator: Annual Serious Game Training
Receives a 30-minute serious game-based training session once per year for three years.
|
Various durations and frequencies of CPR training
|
|
No Intervention: Control
No CPR training
|
|
|
Active Comparator: Standard High-fidelity Manikin
Uses a commercially available torso manikin with realistic chest mechanics and feedback.
Serves as the gold standard comparator for CPR training.
|
Various types of CPR manikins are compared
|
|
Active Comparator: Low-Fidelity Manikin
Uses a basic inflatable torso manikin with minimal feedback or resistance.
Represents a low-cost, commonly used alternative in schools and communities.
|
Various types of CPR manikins are compared
|
|
Active Comparator: No-Head Manikin (Prototype)
Uses a custom-built spring-based device with a silicone topper and realistic force-displacement properties that closely mimic the human chest.
Tests whether an affordable, biomechanically accurate prototype can improve compression quality.
|
Various types of CPR manikins are compared
|
|
Active Comparator: Non-Traditional Object
Uses improvised materials (e.g., toilet paper rolls) to simulate chest compressions.
Evaluates the feasibility and effectiveness of ultra-low-cost CPR practice tools
|
Various types of CPR manikins are compared
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
CPR Skill Retention
Time Frame: 1-4 years
|
High-quality CPR as measured by compression rate (per minute), depth (inches), and correct hand placement.
High-quality CPR is defined as correct rate (100-120/min) AND >70% of compressions at appropriate depth (2-2.4inches) with appropriate hand placement.
|
1-4 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
CPR Attitudes
Time Frame: 1-4 years
|
Participant confidence and intention to perform CPR, measured using Likert-scale items and validated engagement questionnaires.
|
1-4 years
|
|
CPR Knowledge Retention
Time Frame: 1-4 years
|
Percentage of correct answers on a standardized multiple-choice test assessing CPR knowledge and AED use.
|
1-4 years
|
|
Emotional Profile
Time Frame: 1-4 years
|
Emotional responses captured by the Positive and Negative Affect Schedule (PANAS), measuring affective realism and readiness.
|
1-4 years
|
|
Learner Engagement
Time Frame: 1-4 years
|
Subjective engagement and perceived relevance of CPR training, measured via Likert scales and the Narrative Engagement Scale.
|
1-4 years
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Training Feature Effects (Contextualization, Gamification, Emotional Impact)
Time Frame: 1-4 years
|
Exploratory outcome assessing how specific training design elements influence CPR skills, knowledge, and self-efficacy through mediation and regression analyses.
|
1-4 years
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Lorrel Toft, University of Nevada, Reno
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
- Lay Rescuer CPR Training 2026
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
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.
Clinical Trials on Cardiac Arrest, Out-Of-Hospital
-
Singapore General HospitalDuke-NUS Graduate Medical SchoolRecruitingOut-Of-Hospital Cardiac ArrestSingapore
-
National Taiwan University HospitalRecruitingOut-Of-Hospital Cardiac ArrestTaiwan
-
King's College LondonKing's College Hospital NHS Trust; London Ambulance Service NHS TrustNot yet recruiting
-
Wroclaw Medical UniversityWroclaw Emergency Medical ServicesRecruiting
-
Emergency Medical Services, Capital Region, DenmarkTrygFonden, Denmark; Danish Heart Foundation; Zoll Medical CorporationRecruitingOut-Of-Hospital Cardiac ArrestDenmark
-
National Taiwan University HospitalActive, not recruiting
-
University Medical Centre MariborOHK Medical DevicesCompleted"The Effect of the Use of an Autotransfusion Device on Hemodynamic Parameters During Resuscitation".Cardiac Arrest | Out of Hospital Cardiac ArrestSlovenia
-
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityCompletedOut-Of-Hospital Cardiac Arrest
-
Centre Hospitalier Universitaire de BesanconHospices Civils de Lyon; University Hospital, Strasbourg, France; University... and other collaboratorsCompletedOut of Hospital Cardiac ArrestFrance
-
Far Eastern Memorial HospitalCompletedOut-Of-Hospital Cardiac ArrestTaiwan
Clinical Trials on CPR Training
-
Seoul National University HospitalSeoul National University Bundang Hospital; Children's Hospital Los Angeles; Royal...CompletedVirtual Reality | Basic Cardiac Life SupportKorea, Republic of
-
Ankara UniversityNot yet recruitingLow-Dose High-Frequency CPR Training
-
Seoul National University HospitalCompletedCardiopulmonary Resuscitation | Education | Cardiopulmonary ArrestKorea, Republic of
-
Burcu SELVI CALSIKANCompletedBasic Life Support Training Course | Cardiopulmonary Resuscitation (CPR)Turkey (Türkiye)
-
Health Sciences NorthUniversity of Calgary; Royal College of Physicians and Surgeons of CanadaCompletedSimulation TrainingCanada
-
Seoul National University HospitalCompletedCardiac ArrestKorea, Republic of
-
University of PennsylvaniaPatient-Centered Outcomes Research InstituteCompletedCoronary Disease | Cardiac Arrest | Cardiovascular Risk FactorsUnited States
-
Unity Health TorontoHeart and Stroke Foundation of Canada; Zoll Medical CorporationCompletedCardiopulmonary ResuscitationCanada
-
Seoul National University HospitalRecruitingCardiopulmonary Resuscitation | EducationKorea, Republic of
-
Pontificia Universidade Católica do Rio Grande...CompletedCardiopulmonary Arrest With Successful Resuscitation