Augmented Reality to Support Cardiopulmonary Resuscitation

Pediatric Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06376643
• Other study ID #: InterFACE-AR
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 1, 2024
• Est. completion date: October 31, 2025

Study information

• Verified date: April 2024
• Source: Pediatric Clinical Research Platform
• Contact: Johan N Siebert, MD, PD
• Phone: 795534072
• Email: Johan.Siebert[@]hcuge.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical 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, 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.

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. Seventy physicians and nurses, in teams of five will have to manage simulated pediatric in-hospital cardiac arrest (IHCA) scenarios while using the AR-assisted tool or conventional AHA pocket reference cards.

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 70
• Est. completion date: October 31, 2025
• Est. primary completion date: October 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Decline to provide informed consent

• Previously enrolled

• Unable to perform tasks required of the role

Related Conditions & MeSH terms

• Cardiopulmonary Arrest
• Heart Arrest
• Pediatric
• Resuscitation

Intervention

Device:
• 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.

Other:
• 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.

Locations

Country	Name	City	State
Canada	Alberta Children's Hospital	Calgary	Alberta
Switzerland	Geneva Children's Hospital, Geneva University Hospitals	Geneva

Sponsors (3)

Lead Sponsor	Collaborator
Johan Siebert, MD	Alberta Children's Hospital, Calgary, Canada, Geneva Children's Hospital, Geneva, Switzerland

Countries where clinical trial is conducted

Canada,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to first dose of epinephrine	The primary outcome is the time in seconds to first dose of epinephrine administration	20 minutes
Secondary	Time to initiation of cardiopulmonary resuscitation	The time in seconds from the investigator's clinical statement to initiation of chest compression	20 minutes
Secondary	Time to defibrillation	The time in seconds from the investigator's clinical statement to each manual defibrillator shock delivery	20 minutes
Secondary	Time to delivery of epinephrine	The time in seconds from the investigator's clinical statement to intravenous injection of epinephrine to treat underlying condition	20 minutes
Secondary	Time to delivery of amiodarone	The time in seconds from the investigator's clinical statement to intravenous injection of amiodarone to treat underlying condition	20 minutes
Secondary	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	20 minutes
Secondary	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.	20 minutes
Secondary	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)	20 minutes
Secondary	Frequency of Medication Errors	Number of times medication errors occur during the cardiac arrest scenario	20 minutes
Secondary	Frequency of pauses in cardiopulmonary resuscitation	Number of times of cardiopulmonary resuscitation pauses during the cardiac arrest scenario	20 minutes
Secondary	Duration of pauses in cardiopulmonary resuscitation	The total time in seconds of cardiopulmonary resuscitation pauses during the cardiac arrest scenario	20 minutes
Secondary	Causes of pauses in cardiopulmonary resuscitation	The causes leading to resuscitation interruptions will be identified and documented	20 minutes
Secondary	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.	20 minutes
Secondary	Cardiopulmonary resuscitation quality: Chest compression fraction	The fraction of time in seconds that chest compressions are being performed over the total cardiopulmonary resuscitation duration	20 minutes
Secondary	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	20 minutes
Secondary	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)	15 minutes
Secondary	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	15 minutes
Secondary	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	15 minutes
Secondary	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	15 minutes
Secondary	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	15 minutes