- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07363772
Evaluation of Mixed Reality Cardiopulmonary Resuscitation Training (HEROS 4)
Evaluation of Efficacy and Effectiveness of Mixed Reality Cardiopulmonary Resuscitation Training
<Study Design> This study is a cluster-randomized, stratified, non-inferiority trial designed to evaluate the feasibility, efficacy, and educational effectiveness of HEROS 4.0, a mixed-reality (MR)-based cardiopulmonary resuscitation (CPR) training system, compared with conventional instructor-led CPR training.
<Objective & Hypothesis> The primary objective is to determine whether MR-based HEROS 4.0 CPR training is non-inferior to standard video- and instructor-based CPR training in improving CPR performance quality. The central hypothesis is that participants trained using HEROS 4.0 will achieve comparable CPR quality to those trained using traditional methods, while benefiting from enhanced immersion, scalability, and accessibility.
<Participants> A total of 120 adults aged 18-50 years who have not received CPR training within the previous 12 months will be recruited. Participants will be assigned to one of two clusters and randomized in a 1:1 ratio to either the HEROS 4.0 MR training group or the conventional CPR training group.
<Intervention & Control>
Participants will undergo CPR training according to their assigned group:
Intervention group (HEROS 4.0):
Participants will receive a two-stage CPR training program consisting of pre-training and on-site MR-based training. As pre-training, participants will be instructed to watch a 40-minute instructional video (conventional CPR training group video) at home prior to their visit. After completing the pre-training, participants will undergo 20 minutes of MR-based CPR training using the HEROS 4.0 system in a dedicated CPR training booth.
Control group (Conventional CPR training):
Participants will receive 60 minutes of standard CPR education delivered through instructional videos and in-person instructor guidance, reflecting current community CPR training practice.
<Outcomes> Immediately after training, all participants will undergo a standardized cardiac arrest simulation using a CPR quality-measurement manikin. This simulation will assess objective CPR performance metrics as well as subjective outcomes through questionnaires.
To evaluate knowledge retention and skill durability, all assessments will be repeated 6 months after training using the same simulation scenario and outcome measures.
The primary outcome is chest compression fraction measured during the standardized simulated cardiac arrest scenario.
Secondary outcomes include quantitative measures of CPR quality and participant-reported outcomes based on survey.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Dong Hyun Choi, MD, PhD
- Phone Number: 82-2-2072-4646
- Email: donghyun369@naver.com
Study Locations
-
-
Nowon-gu
-
Seoul, Nowon-gu, South Korea, 01689
- Recruiting
- Nowon-gu Public Health Center
-
Contact:
- Dong Hyun Choi, MD, PhD
- Phone Number: 82-2-2072-4646
- Email: donghyun369@naver.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Adults aged 18-50 years who have not received CPR training within the previous 12 months.
Exclusion Criteria:
- Healthcare professionals
- Individuals unable to safely tolerate MR equipment (e.g. motion sickness)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: HEROS 4.0
Participants will receive a two-stage CPR training program consisting of pre-training and on-site MR-based training.
As pre-training, participants will be instructed to watch a 40-minute instructional video (conventional CPR training group video) at home prior to their visit.
After completing the pre-training, participants will undergo 20 minutes of MR-based CPR training using the HEROS 4.0 system in a dedicated CPR training booth.
|
Participants will receive a two-stage CPR training program consisting of pre-training and on-site MR-based training.
As pre-training, participants will be instructed to watch a 40-minute instructional video (conventional CPR training group video) at home prior to their visit.
After completing the pre-training, participants will undergo 20 minutes of MR-based CPR training using the HEROS 4.0 system in a dedicated CPR training booth.
The MR-based CPR training content consists of cardiac arrest recognition, calling emergency medical services, chest compressions, and use of an automated external defibrillator, while minimizing interruptions in chest compressions.
|
|
Active Comparator: Conventional CPR training
Participants will receive 60 minutes of standard CPR education delivered through instructional videos and in-person instructor guidance, reflecting current community CPR training practice.
|
Participants will receive 60 minutes of standard CPR education delivered through instructional videos and in-person instructor guidance, reflecting current community CPR training practice.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Chest compression fraction
Time Frame: (1) Immediately after training and (2) at 6-month follow-up.
|
Chest compression fraction (CCF) is defined as the proportion of total resuscitation time during which chest compressions are actively delivered.
Chest compression quality metrics including CCF will be measured during a standardized cardiac arrest simulation using a CPR quality-measurement manikin.
|
(1) Immediately after training and (2) at 6-month follow-up.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mean chest compression depth
Time Frame: (1) Immediately after training and (2) at 6-month follow up.
|
The average depth of all chest compressions delivered during the simulated resuscitation.
|
(1) Immediately after training and (2) at 6-month follow up.
|
|
Mean chest compression rate
Time Frame: (1) Immediately after training and (2) at 6-month follow up.
|
The average number of chest compressions performed per minute during the CPR simulation.
|
(1) Immediately after training and (2) at 6-month follow up.
|
|
Proportion of compressions with adequate depth
Time Frame: (1) Immediately after training and (2) at 6-month follow up.
|
The percentage of chest compressions that meet guideline-recommended depth (5-6 cm) criteria during the simulation.
|
(1) Immediately after training and (2) at 6-month follow up.
|
|
Proportion of compressions with adequate rate
Time Frame: (1) Immediately after training and (2) at 6-month follow up.
|
The percentage of chest compressions that fall within the guideline-recommended (100-120 compressions per minute) compression rate range.
|
(1) Immediately after training and (2) at 6-month follow up.
|
|
Overall basic life support performance
Time Frame: (1) Immediately after training and (2) at 6-month follow up.
|
Measurement of basic life support performance during standardized cardiac arrest simulation using the following checklist items including: Check response / Assess breathing / Call EMS and get help / Chest compressions / Activate AED and attach pads / Stand clear / Deliver shock / Minimize CPR interruptions / |
(1) Immediately after training and (2) at 6-month follow up.
|
|
CPR self-efficacy
Time Frame: (1) Before training, (2) immediately after training and (3) at 6-month follow-up.
|
Participants' self-efficacy in performing CPR will be evaluated using a modified version of the Basic Resuscitation Skills Self-Efficacy Scale (BRS-SES), consisting of 15 items rated on a 11-point Likert scale (converted to 0-100 scale), with higher scores indicating greater self-efficacy.
|
(1) Before training, (2) immediately after training and (3) at 6-month follow-up.
|
|
System Usability Scale
Time Frame: Immediately after training
|
The usability of the MR-based CPR Training program will be evaluated using the System Usability Scale (SUS), a validated 10-item questionnaire rated on a 5-point Likert scale, with higher scores indicating better usability.
This assessment will be conducted only in the experimental group.
|
Immediately after training
|
Collaborators and Investigators
Investigators
- Study Chair: Sang Do Shin, MD, PhD, Seoul National University Hospital
Study record dates
Study Major Dates
Study Start (Actual)
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2401-048-1500
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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