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临床试验/NCT06376643
NCT06376643已完成不适用

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

Johan Siebert, MD4 个研究点 分布在 2 个国家目标入组 54 人开始时间: 2025年4月2日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
54
试验地点
4
主要终点
Time to first dose of epinephrine

研究概览

简要总结

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.

详细描述

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).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Outcomes Assessor)

盲法说明

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.

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

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

结局指标

主要结局

Time to first dose of epinephrine

时间窗: 20 minutes

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

次要结局

  • 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)
  • Causes of pauses in cardiopulmonary resuscitation(20 minutes)
  • Cardiopulmonary resuscitation quality: Percentage of overall excellent cardiopulmonary resuscitation(20 minutes)
  • Cardiopulmonary resuscitation quality: Chest compression fraction(20 minutes)
  • Cardiopulmonary resuscitation quality: Peri-shock pause duration(20 minutes)
  • Medication dosage errors(20 minutes)
  • Types of Medication Errors(20 minutes)
  • Frequency of Medication Errors(20 minutes)
  • Frequency of pauses in cardiopulmonary resuscitation(20 minutes)
  • Duration of pauses in cardiopulmonary resuscitation(20 minutes)
  • Provider workload (NASA-TLX)(15 minutes)
  • User Experience Questionnaire (UEQ)(15 minutes)
  • System Usability Scale (SUS)(15 minutes)
  • Unified Theory of Acceptance and Use of Technology questionnaire (UTAUT)(15 minutes)
  • State-Trait Anxiety Inventory (STAI) form Y-1(15 minutes)
  • Visual attention patterns of team leader and medication nurse on augmented reality and resuscitation room elements(20 minutes)
  • Team Emergency Assessment Measure (TEAM) survey(10 minutes)
  • Concise Assessment of Leader Management (CALM) Survey(10)

研究者

发起方
Johan Siebert, MD
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Johan Siebert, MD

MD, PD, Deputy Head

Pediatric Clinical Research Platform

研究点 (4)

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