Augmented Reality to Support Cardiopulmonary Resuscitation

NCT06376643 | Completed DMC

• 1 other identifier: InterFACE-AR
• Study Type: interventional
• Target: 54
• Locations: 2 countries
• Sites: 2

Brief Summary

A prospective, multicenter, randomized clinical trial in two tertiary pediatric emergency department. It will assess, amongst pediatric healthcare teams, whether the use of augmented reality supportive devices improves adherence to American Heart Association (AHA) advanced life support guidelines and performance, while reducing medication errors, when compared to groups using the AHA pocket reference card (control) during standardized, simulation-based, pediatric in-hospital cardiac arrest (IHCA) scenarios. Seventy participants will be randomized. The primary endpoint is the time to first dose of epinephrine.

Conditions

Cardiopulmonary Arrest; Resuscitation; Pediatric

Keywords

Cardiopulmonary Resuscitation; Augmented Reality; Digital Health; Pediatrics

Outcome Measures

Primary Outcomes (1)

• Time to first dose of epinephrine

  The primary outcome is the time in seconds to first dose of epinephrine administration

  20 minutes

Secondary Outcomes (22)

• Time to initiation of cardiopulmonary resuscitation

  20 minutes

• Time to defibrillation

  20 minutes

• Time to delivery of epinephrine

  20 minutes

• Time to delivery of amiodarone

  20 minutes

• Time to secure definitive airway

  20 minutes

Study Arms (2)

Arm A (Augmented Reality)

EXPERIMENTAL

Participants that will use the augmented reality supportive tool during the simulation-based pediatric scenario.

Device: Augmented reality supportive tool

Arm B (Conventional methods)

ACTIVE COMPARATOR

Participants that will use conventional methods during the simulation-based pediatric scenario.

Other: Conventional method (AHA pocket reference card)

Interventions

Augmented reality supportive tool DEVICE

Participants will view a standardized orientation video describing the clinical environment, equipment, manikin functionality, and participant roles, followed by a 15-minute table-top practice simulation where participants have opportunity to use the assigned intervention by running through a cardiac arrest scenario. Then, participants will undertake a 20-minute tightly standardized cardiac arrest simulation scenario using a high-fidelity pediatric manikin. The scenarios will be videotaped from a bird's-eye view angle at the foot of the bed, along with three action video cameras worn by the participants, and positioned within the room. Following completion of the scenario, participants will fill out five surveys (see secondary outcomes), which together take about 15 minutes to fill.

Arm A (Augmented Reality)

Conventional method (AHA pocket reference card) OTHER

Participants will view a standardized orientation video describing the clinical environment, equipment, manikin functionality, and participant roles, followed by a 15-minute table-top practice simulation where participants have opportunity to use the assigned intervention by running through a cardiac arrest scenario Then, participants will undertake a 20-minute tightly standardized cardiac arrest simulation scenario using a high-fidelity pediatric manikin. The scenarios will be videotaped from a bird's-eye view angle at the foot of the bed, along with three action video cameras worn by the participants, and positioned within the room. Following completion of the scenario, participants will fill out five surveys (see secondary outcomes), which together take about 15 minutes to fill.

Arm B (Conventional methods)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants must have prior basic life support training.
• Participation agreement.

You may not qualify if:

• Decline to provide informed consent
• Previously enrolled
• Unable to perform tasks required of the role

Sponsors & Collaborators

• Johan Siebert, MD: lead
• University Hospital, Geneva: collaborator
• Alberta Children's Hospital: collaborator

Study Sites (2)

Alberta Children's Hospital

Calgary, Alberta, AB T3B 6A8,, Canada

Location

Geneva Children's Hospital, Geneva University Hospitals

Geneva, 1205, Switzerland

Location

MeSH Terms

Conditions

Heart Arrest

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Johan N Siebert, MD, PD

  Geneva Children's Hospital, Geneva, Switzerland

  PRINCIPAL INVESTIGATOR

• Adam Cheng, Prof

  Alberta Children's Hospital, Calgary, Canada

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: It will not be possible to blind study participants to study arm allocation due to the nature of the intervention(s), but they will be blinded to study objectives. The statistician will be blinded regarding the allocation of participants to the study arms for results analysis.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD, PD, Deputy Head

Model Details: Open-label, prospective, multicenter, cluster randomized controlled clinical trial

Study Record Dates

• First Submitted: April 16, 2024
• First Posted: April 19, 2024
• Study Start: April 2, 2025
• Primary Completion: July 1, 2025
• Study Completion: July 1, 2025
• Last Updated: August 19, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1); CH (1)