Augmented Reality to Support Cardiopulmonary Resuscitation

NCT ID: NCT06376643

Last Updated: 2025-08-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-02
• Study Completion Date: 2025-07-01

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.

Detailed Description

Each year, thousands of children experience cardiopulmonary arrests (CA), requiring immediate and accurate resuscitation for favorable outcomes. However, adherence to American Heart Association (AHA) advanced life support guidelines remains suboptimal, hindered by cognitive and communication challenges in high-stress cardiopulmonary resuscitation (CPR) situations. To address this problem, will assess a novel augmented reality (AR)-assisted digital health solution designed to offer personalized, real-time decision support for team leaders and medication nurses, while concurrently optimizing team situational awareness and communication by projecting a dynamic care roadmap onto a large screen in the resuscitation room, controlled via a mobile tablet app.

The solution comprises three essential digitally interconnected elements: 1) a mobile app that presents clinical algorithms alongside patient data, guiding the resuscitation team through step-by-step procedures, 2) a giant screen that displays real-time patient information and task progress for the entire resuscitation team, and 3) augmented reality devices worn by team members, providing role-specific guidance and decision support based on data collected by the app.

In this trial, we will assess, amongst pediatric healthcare teams, whether the use of the AR-assisted tool improves adherence to AHA resuscitation guidelines and performance, while reducing medication errors, when compared to groups using the AHA pocket reference card (control) in an open-label, prospective, multicenter, cluster randomized (1:1 ratio) clinical trial. Sixty physicians and nurses will be recruited to form teams of 7, each managing simulated pediatric in-hospital cardiac arrest (IHCA) scenarios using either an AR-assisted tool or conventional AHA pocket reference cards. Each team will comprise three participants assigned to the roles of 1) Team Leader (a physician), 2) Charting Nurse, and 3) Medication Nurse, with two CPR Providers, an Airway Provider, and a Bedside Provider roles filled by research actors. All participants and actors will view a CPR Coach orientation video to ensure understanding of the CPR Coach and Provider functions

The primary outcome is the time in seconds to first dose of epinephrine. Secondary outcomes are times to CPR initiation, defibrillation, drug delivery, airway securing, the rate of medication errors, CPR pause frequency, CPR quality (excellent CPR percentage, chest compression fraction, peri-shock pause duration), provider workload (NASA-TLX survey) and stress (STAI), user experience (UEQ), system usability (SUS), and technology acceptance (UTAUT).

Conditions

Cardiopulmonary Arrest; Resuscitation; Pediatric

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Arm A (Augmented Reality)

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

Group Type: EXPERIMENTAL

Augmented reality supportive tool

Intervention Type: 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 B (Conventional methods)

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

Group Type: ACTIVE_COMPARATOR

Conventional method (AHA pocket reference card)

Intervention Type: 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.

Interventions

Augmented reality supportive tool

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.

Intervention Type: DEVICE

Conventional method (AHA pocket reference card)

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University Hospital, Geneva

OTHER

Sponsor Role: collaborator

Alberta Children's Hospital

OTHER

Sponsor Role: collaborator

Johan Siebert, MD

OTHER

Sponsor Role: lead

Responsible Party

Johan Siebert, MD

MD, PD, Deputy Head

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Johan N Siebert, MD, PD

Role: PRINCIPAL_INVESTIGATOR

Geneva Children's Hospital, Geneva, Switzerland

Adam Cheng, Prof

Role: STUDY_DIRECTOR

Alberta Children's Hospital, Calgary, Canada

Locations

Alberta Children's Hospital

Calgary, Alberta, Canada

Geneva Children's Hospital, Geneva University Hospitals

Geneva, , Switzerland

Countries

Canada; Switzerland

Other Identifiers

InterFACE-AR

Identifier Type: -

Identifier Source: org_study_id