Clinical trial NCT06376643: Augmented Reality to Support Cardiopulmonary Resuscitation
Official title: Evaluation of an Augmented Reality and Screen-based Decision Support System for Cardiopulmonary Arrest: a Multicenter, Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cardiopulmonary Arrest
Resuscitation
Pediatric
Keywords: Cardiopulmonary Resuscitation
Augmented Reality
Digital Health
Pediatrics
Lead sponsor: Pediatric Clinical Research Platform
Sponsor class: OTHER
Collaborators: name: University Hospital, Geneva
name: Alberta Children's Hospital
First posted: 2024-04-19
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Open-label, prospective, multicenter, cluster randomized controlled clinical trial
Primary purpose: OTHER

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).

Eligibility criteria: 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

Primary outcomes:
measure: Time to first dose of epinephrine
timeFrame: 20 minutes
Secondary outcomes:
measure: Time to initiation of cardiopulmonary resuscitation
timeFrame: 20 minutes
measure: Time to defibrillation
timeFrame: 20 minutes
measure: Time to delivery of epinephrine
timeFrame: 20 minutes
measure: Time to delivery of amiodarone
timeFrame: 20 minutes
measure: Time to secure definitive airway
timeFrame: 20 minutes
measure: Medication dosage errors
timeFrame: 20 minutes
measure: Types of Medication Errors
timeFrame: 20 minutes
measure: Frequency of Medication Errors
timeFrame: 20 minutes
measure: Frequency of pauses in cardiopulmonary resuscitation
timeFrame: 20 minutes
measure: Duration of pauses in cardiopulmonary resuscitation
timeFrame: 20 minutes
measure: Causes of pauses in cardiopulmonary resuscitation
timeFrame: 20 minutes
measure: Cardiopulmonary resuscitation quality: Percentage of overall excellent cardiopulmonary resuscitation
timeFrame: 20 minutes
measure: Cardiopulmonary resuscitation quality: Chest compression fraction
timeFrame: 20 minutes
measure: Cardiopulmonary resuscitation quality: Peri-shock pause duration
timeFrame: 20 minutes
measure: Provider workload (NASA-TLX)
timeFrame: 15 minutes
measure: User Experience Questionnaire (UEQ)
timeFrame: 15 minutes
measure: System Usability Scale (SUS)
timeFrame: 15 minutes
measure: Unified Theory of Acceptance and Use of Technology questionnaire (UTAUT)
timeFrame: 15 minutes
measure: State-Trait Anxiety Inventory (STAI) form Y-1
timeFrame: 15 minutes
measure: Visual attention patterns of team leader and medication nurse on augmented reality and resuscitation room elements
timeFrame: 20 minutes
measure: Team Emergency Assessment Measure (TEAM) survey
timeFrame: 10 minutes
measure: Concise Assessment of Leader Management (CALM) Survey
timeFrame: 10
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Alberta Children's Hospital
state: Alberta
city: Geneva
country: Switzerland
facility: Geneva Children's Hospital, Geneva University Hospitals
Study officials:
affiliation: Geneva Children's Hospital, Geneva, Switzerland
name: Johan N Siebert, MD, PD
role: PRINCIPAL_INVESTIGATOR
affiliation: Alberta Children's Hospital, Calgary, Canada
name: Adam Cheng, Prof
role: STUDY_DIRECTOR
References: