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Cardiopulmonary ArrestNCT06376643

Augmented Reality to Support Cardiopulmonary Resuscitation

A study testing Augmented reality supportive tool and Conventional method (AHA pocket reference card) in people with Cardiopulmonary Arrest and Resuscitation, run by Johan Siebert, MD at 2 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 70 yearsHealthy volunteers can take part
Conditions the study is for
Cardiopulmonary Arrest, Resuscitation, Pediatric
What is being tested?
Augmented reality supportive tool and Conventional method (AHA pocket reference card)
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
54 participants
Where
2 sitesin 2 countries
Study dates
2 Apr 2025to 1 Jul 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Inclusion criteria for the team leader include: attending physician, fellow, or senior resident in emergency medicine, pediatric emergency medicine, pediatrics, pediatric critical care, or pediatric anesthesia.
  • Inclusion criteria for the medication and charting nurse roles include: nurse in pediatric emergency medicine, general pediatrics, or other pediatric acute care specialty.
  • Inclusion criteria for all other team members include: pediatric attending physician, resident, fellow, nurse or respiratory therapist.
  • Participants must have prior basic life support training.
  • Participation agreement.

Who cannot join

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

Trial locations and contacts

2 sites in 2 countries.

2 sites in 2 countries

Canada1 site
  • Alberta Children's Hospital

    Calgary, Alberta, AB T3B 6A8,

Other trials in Canada

Switzerland1 site
  • Geneva Children's Hospital, Geneva University Hospitals

    Geneva, 1205

Other trials in Switzerland

About this study

Official title: Evaluation of an Augmented Reality and Screen-based Decision Support System for Cardiopulmonary Arrest: a Multicenter, Randomized Clinical Trial

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.

Read the 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).

Being tested
Augmented reality supportive tool, Conventional method (AHA pocket reference card)
Keywords
Cardiopulmonary Resuscitation, Augmented Reality, Digital Health, Pediatrics
Medical subject headings
Heart Arrest

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Augmented reality supportive toolDevice

    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.

  • 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.

Study groups in NCT06376643
Study groupRoleWhat they receive
Arm A (Augmented Reality)ExperimentalParticipants that will use the augmented reality supportive tool during the simulation-based pediatric scenario.
Receives: Device: Augmented reality supportive tool
Arm B (Conventional methods)Active comparatorParticipants that will use conventional methods during the simulation-based pediatric scenario.
Receives: Other: Conventional method (AHA pocket reference card)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time to first dose of epinephrine

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

    Measured: 20 minutes

Secondary outcomes (22)
  1. Time to initiation of cardiopulmonary resuscitation

    The time in seconds from the investigator's clinical statement to initiation of chest compression

    Measured: 20 minutes

  2. Time to defibrillation

    The time in seconds from the investigator's clinical statement to each manual defibrillator shock delivery

    Measured: 20 minutes

  3. Time to delivery of epinephrine

    The time in seconds from the investigator's clinical statement to intravenous injection of epinephrine to treat underlying condition

    Measured: 20 minutes

  4. Time to delivery of amiodarone

    The time in seconds from the investigator's clinical statement to intravenous injection of amiodarone to treat underlying condition

    Measured: 20 minutes

  5. Time to secure definitive airway

    The time in seconds from the investigator's clinical statement to the successful establishment of a definitive airway via endotracheal intubation

    Measured: 20 minutes

  6. Medication dosage errors

    Errors in drug dose administration (milligrams), defined as a deviation from the correct weight-based dose of more than 10% according to predefined, expert consensus-based criteria, will be measured (i.e., absolute and percentage deviation) in each allocation group as a deviation from the 2020 AHA Pediatric Advanced Life Support cardiac arrest algorithm.

    Measured: 20 minutes

  7. Types of Medication Errors

    The nature of the error type will be recorded, such as incorrect drug selection (i.e., administering the wrong medication), administration timing errors (i.e., administering the medication at the wrong time during the resuscitation process), labeling errors (i.e., misinterpreting or misreading the medication label), equipment-related errors (i.e., issues related to the functioning or availability of equipment needed for drug administration [e.g., syringe malfunction]), and documentation errors (i.e., inaccurate or incomplete recording of medication administration details)

    Measured: 20 minutes

  8. Frequency of Medication Errors

    Number of times medication errors occur during the cardiac arrest scenario

    Measured: 20 minutes

  9. Frequency of pauses in cardiopulmonary resuscitation

    Number of times of cardiopulmonary resuscitation pauses during the cardiac arrest scenario

    Measured: 20 minutes

  10. Duration of pauses in cardiopulmonary resuscitation

    The total time in seconds of cardiopulmonary resuscitation pauses during the cardiac arrest scenario

    Measured: 20 minutes

  11. Causes of pauses in cardiopulmonary resuscitation

    The causes leading to resuscitation interruptions will be identified and documented

    Measured: 20 minutes

  12. Cardiopulmonary resuscitation quality: Percentage of overall excellent cardiopulmonary resuscitation

    The proportion of cardiopulmonary resuscitation administrations that meet the predefined AHA standards for high-quality resuscitation techniques.

    Measured: 20 minutes

  13. Cardiopulmonary resuscitation quality: Chest compression fraction

    The fraction of time in seconds that chest compressions are being performed over the total cardiopulmonary resuscitation duration

    Measured: 20 minutes

  14. Cardiopulmonary resuscitation quality: Peri-shock pause duration

    The length of time in seconds between the cessation of chest compressions and the delivery of a defibrillation shock during cardiopulmonary resuscitation

    Measured: 20 minutes

  15. Provider workload (NASA-TLX)

    Assessed via NASA-TLX. It measures mental burden across 6 dimensions: mental, physical, temporal demands, performance, effort, and frustration. Scores range from 0 to 100 in 5-point increments (0: no task load; 100: maximal task load). Participants rate each dimension based on their perceived workload. To combine the dimensions into a final score, a weighting procedure is used. This involves comparing each dimension with every other dimension to determine its relative importance in influencing workload. Participants select the dimension that contributes most to workload in each pair of comparisons. Each dimension is then weighted based on the participant's selections, with higher weights given to dimensions that are chosen more frequently. The weighted scores for each dimension are summed to calculate the overall score, which ranges from 0 (minimal task load) to 100 (maximal task load)

    Measured: 15 minutes

  16. User Experience Questionnaire (UEQ)

    UEQ is a widely used questionnaire to measure the subjective impression of users towards the user experience of products. The UEQ is a semantic differential with 26 items that are grouped into six scales (Attractiveness, Perspicuity, Efficiency, Dependability, Stimulation, and Novelty). Each scale represents a distinct usability quality aspect. The minimum value is 0 (i.e., the worst user experience) and the maximum value is 100 (i.e., the best user experience). Participants will be asked to complete the UEQ directly after they have completed the resuscitation scenario

    Measured: 15 minutes

  17. System Usability Scale (SUS)

    SUS is a widely used questionnaire for assessing the perceived usability of a system or product. The SUS consists of a 10-item questionnaire where users rate their agreement or disagreement with a series of statements regarding the usability of a system using a 5-point Likert scale (1 to 5). The minimum value is 0 (i.e., the system is not usable) and the maximum value is 100 (i.e., the system is absolutely usable). Participants will be asked to complete the SUS directly after they have completed the resuscitation scenario

    Measured: 15 minutes

  18. Unified Theory of Acceptance and Use of Technology questionnaire (UTAUT)

    The UTAUT consists of eight domains (performance expectancy, effort expectancy, social influence, facilitating conditions, hedonic motivation, price value, habit, and behavioural intention). This measure will be adapted to assess participants' perceived usability, usefulness, and intention to use the augmented reality-aided tool after study completion. Responses are rated on a 7-point likert scale from 1=Strongly disagree to 7=Strongly agree. Participants will be asked to complete the UTAUT directly after they have completed the resuscitation scenario

    Measured: 15 minutes

  19. State-Trait Anxiety Inventory (STAI) form Y-1

    This questionnaire is composed of 20-item self-report subscales to measure the temporary state of anxiety at the time of reporting (STAI form Y-1), which can be affected by stressful situations. Each item is answered on a 4-point Likert scale ranging from 1 (not at all) to 4 (very much). After reversing the scores for stress-absent items (ie, items 1, 2, 5, 8, 10, 11, 15, 16, 19, and 20), the total score is calculated by summing up the weighted scores for the 20 items. STAI ranges from 20 to 80, with higher scores being positively correlated with greater stress. The range of possible scores range from a minimum score of 20 to a maximum score of 80. STAI scores are commonly classified as "no or low anxiety" (20-37), "moderate anxiety" (38-44), and "high anxiety" (45-80). Participants will be asked to complete the STAI directly after they have completed the resuscitation scenario

    Measured: 15 minutes

  20. Visual attention patterns of team leader and medication nurse on augmented reality and resuscitation room elements

    Duration and number of visual fixations on pre-defined area of interest (AOI) for the team leader and medication nurse, as captured by the augmented reality device (Microsoft Hololens2). AOIs will include the holograms projected within each augmented reality device, as well as the LCD screen within the resuscitation room and manikin for the team leader.

    Measured: 20 minutes

  21. Team Emergency Assessment Measure (TEAM) survey

    The TEAM survey is a validated tool designed to assess team performance during emergency scenarios, focusing on non-technical skills. It consists of 11 items rated on a 5-point Likert scale (0 [Never/Hardly ever] to 4 [Always/Nearly always]) across three domains: Leadership, Teamwork, and Task Management, with an additional overall performance rating. Scores range from 0 (poor performance) to 44 (excellent performance), providing a comprehensive measure of team dynamics, communication, and coordination. Participants will complete the TEAM survey immediately after each resuscitation scenario to evaluate the team's effectiveness in managing the simulated IHCA

    Measured: 10 minutes

  22. Concise Assessment of Leader Management (CALM) Survey

    The CALM survey is a validated tool for assessing leadership in acute resuscitation scenarios, focusing on the Team Leader's performance. It includes 15 four-point Likert scale items (rarely, sometimes, mostly, always) across 4 domains-Leadership (role and style, 2 items), Communication (clarity and closed-loop reinforcement, 2 items), Team Management (role assignment, task direction, workload balance, team engagement, and case summarization, 5 items), and Medical Management (task prioritization, global awareness, patient reassessment, care planning, and help-seeking, 5 items)-plus 1 dichotomous behavioral item (yes/no on role announcement) and 1 global rating item comparing the leader to peers (below expected, as expected, above expected, top 5%). Scores for the Likert items range from 15 (poor leadership) to 60 (outstanding leadership), with additional binary and comparative assessments. Team members will complete the CALM survey immediately after each resuscitation scenario.

    Measured: 10

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Apr 2024
  2. Study start2 Apr 2025
  3. Primary completion1 Jul 2025
  4. Study completion1 Jul 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Model description
Open-label, prospective, multicenter, cluster randomized controlled clinical trial
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
54 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06376643
Sponsor's protocol ID
InterFACE-AR
Status last verified
Aug 2025
First submitted
16 Apr 2024
Last updated
19 Aug 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Lin Y, Masi A, Kang R, Manzano S, Siebert JN, Davidson J, Ehrler F, Courvoisier DS, Duncan D, Rajic A, Olanka SK, Generelli M, Kim K, Cheng A; InterFACE-AR Clinical Investigators. Distribution of visual attention amongst clinicians using an augmented reality-based decision support system during simulated cardiac arrest - A descriptive study. Resusc Plus. 2026 Aug 5;31:101433. doi: 10.1016/j.resplu.2026.101433. eCollection 2026 Sep.

    PubMed 42633257
  • Siebert JN, Cheng A, De Masi A, Rajic A, Olanka SK, Generelli M, Davidson J, Kang R, Kim K, Rebours PL, Ibrahim M, Duncan D, Jordan I, Ehrler F, Courvoisier DS, Lin Y, Manzano S. Augmented Reality-Guided Decision Support in Simulated Pediatric Cardiac Arrest: A Randomized Clinical Trial. JAMA Netw Open. 2026 May 1;9(5):e2614030. doi: 10.1001/jamanetworkopen.2026.14030.

    PubMed 42172032
  • Cheng A, Manzano S, Siebert JN, De Masi A, Davidson J, Kim K, Ehrler F, Courvoisier DS, Duncan D, Rajic A, Olanka SK, Kang R, Lin Y; InterFACE-AR Clinical Investigators. Impact of an augmented reality-based decision support system on teamwork, leadership, provider workload and cognitive load during simulated cardiac arrest - a simulation-based randomized controlled trial. Adv Simul (Lond). 2026 May 1;11(1):44. doi: 10.1186/s41077-026-00444-9.

    PubMed 42067953

Questions about this trial

What is this clinical trial studying?

A study testing Augmented reality supportive tool and Conventional method (AHA pocket reference card) in people with Cardiopulmonary Arrest and Resuscitation, run by Johan Siebert, MD at 2 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Canada, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to first dose of epinephrine (time frame: 20 minutes). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06376643, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2025.

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