NCT07363772

Brief Summary

\<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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
19mo left

Started Feb 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Study Progress19%
Feb 2026Dec 2027

First Submitted

Initial submission to the registry

January 15, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 23, 2026

Completed
9 days until next milestone

Study Start

First participant enrolled

February 1, 2026

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

April 28, 2026

Status Verified

April 1, 2026

Enrollment Period

11 months

First QC Date

January 15, 2026

Last Update Submit

April 26, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Chest compression fraction

    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 Outcomes (7)

  • Mean chest compression depth

    (1) Immediately after training and (2) at 6-month follow up.

  • Mean chest compression rate

    (1) Immediately after training and (2) at 6-month follow up.

  • Proportion of compressions with adequate depth

    (1) Immediately after training and (2) at 6-month follow up.

  • Proportion of compressions with adequate rate

    (1) Immediately after training and (2) at 6-month follow up.

  • Overall basic life support performance

    (1) Immediately after training and (2) at 6-month follow up.

  • +2 more secondary outcomes

Study Arms (2)

HEROS 4.0

EXPERIMENTAL

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.

Other: HEROS 4.0

Conventional CPR training

ACTIVE COMPARATOR

Participants will receive 60 minutes of standard CPR education delivered through instructional videos and in-person instructor guidance, reflecting current community CPR training practice.

Other: Conventional CPR training

Interventions

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.

HEROS 4.0

Participants will receive 60 minutes of standard CPR education delivered through instructional videos and in-person instructor guidance, reflecting current community CPR training practice.

Conventional CPR training

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Adults aged 18-50 years who have not received CPR training within the previous 12 months.

You may not qualify if:

  • Healthcare professionals
  • Individuals unable to safely tolerate MR equipment (e.g. motion sickness)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nowon-gu Public Health Center

Seoul, Nowon-gu, 01689, South Korea

RECRUITING

MeSH Terms

Conditions

Heart Arrest

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Sang Do Shin, MD, PhD

    Seoul National University Hospital

    STUDY CHAIR

Central Study Contacts

Dong Hyun Choi, MD, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 15, 2026

First Posted

January 23, 2026

Study Start

February 1, 2026

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2027

Last Updated

April 28, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations