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临床试验/NCT06411327
NCT06411327尚未招募不适用

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

KidSIM Simulation Program0 个研究点目标入组 400 人开始时间: 2025年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
400
主要终点
Time to epinephrine

研究概览

简要总结

Cognitive aids are decision support tools that present prompts to encourage recall of information, thus freeing up mental resources to increase the likelihood of desired behaviors. Cognitive aids have been trialed in different forms for use during resuscitation, including pocket reference cards and digital apps. Simulation-based studies of cognitive aid used during cardiac arrest events have shown improved adherence to guidelines, improved time to completing critical tasks, and reduced rate of critical errors. Unfortunately, existing pocket reference cards and mobile apps have significant flaws - they all require providers to search through content to identify relevant information.

In the proposed study, the investigators will evaluate the impact of an enhanced system, InterFACE-AR, which provides role-specific decision support to the team leader and medication nurse through AR devices, while concurrently optimizing team situational awareness by displaying a roadmap for patient care on the LCD screen. Clinical data will be collected from the mobile app on a tablet used by the charting nurse. The trial aims to assess the individual and combined effectiveness of InterFACE-AR components (i.e. AR devices and LCD screen) on adherence to AHA resuscitation guidelines during simulated cardiac arrest by conducting a randomized controlled trial with a factorial design.

详细描述

Introduction Cardiopulmonary resuscitation (CPR) is provided for thousands of patients suffering from cardiopulmonary arrests (CPA) each year in North America. The provision of guideline-compliant basic life support (BLS) and advanced life support (ALS) improves patient outcomes following cardiac arrest. Unfortunately, healthcare providers struggle to consistently perform guideline-compliant BLS4, 5 and ALSuring in-hospital cardiac arrest. Deviations from American Heart Association (AHA) resuscitation guidelines are associated with decreased survival from in-hospital cardiac arrest, signaling a pressing need to design, evaluate, and implement novel strategies to improve the delivery of BLS and ALS care.

Delays in epinephrine administration, delays in defibrillation, medication dosing errors, and errors in identification and treatment of the underlying condition, represent common deviations from resuscitation guidelines associated with poor patient outcomes from cardiac arrest. Prior studies point to high mental workload amongst resuscitation team members as a major contributor to protocol deviations. The dynamic nature of resuscitation presents a significant challenge for team leaders, who engage in complex cognitive process that result in extremely high mental workload, leading to poor decision-making and errors. Reducing mental workload of team members by providing decision support during resuscitation can potentially improve quality of care during cardiac arrest. The investigators aim to address these issues by designing a novel system that integrates augmented reality (AR) and screen-based technology to provide decision support for resuscitation teams during cardiopulmonary arrest.

Cognitive aids are decision support tools that present prompts to encourage recall of information, thus freeing up mental resources to increase the likelihood of desired behavior. Cognitive aids have been trialed in different forms for use during resuscitation, including pocket reference cards and digital apps. Simulation-based studies of cognitive aid used during cardiac arrest events have shown improved adherence to guidelines, improved time to completing critical tasks, and reduced rate of critical errors. Unfortunately, existing pocket reference cards and mobile apps have significant flaws - they all require providers to search through content to identify relevant information. This presents a distraction and increases mental workload - resulting in impaired communication and poor situational awareness - both of which cause delays and errors in treatment.

Augmented reality (AR) and display screens have the potential of addressing these gaps. Augmented reality can present individualized, role-specific guidance to potentially reduce mental workload; while a display screen in the clinical environment can offer information to the entire team to improve communication and enhance situational awareness.

Augmented reality using a head-mounted device allows for participant interaction with the real environment while displaying three-dimensional interactive images in a user's field of view without disturbing normal vision. AR-based cognitive aids enable fast decision making by providing clinically relevant prompts and supporting anticipatory behaviors by listing upcoming tasks. Studies completed by our research team have shown that an AR device providing clinical guidance for the team leader improves compliance with pediatric and neonatal resuscitation guidelines, but fell short on improving time to epinephrine or defibrillation. In these studies, the AR systems were entirely reliant upon data collected from the team leader through the AR device to determine the clinical guidance. This amplified team leader workload which contributed to delays in task completionIn designing a new system, our overarching goal is to reduce mental workload by providing role-specific and timely information to key team resuscitation team members. To achieve this goal, the investigators developed a mobile app (i.e. Guiding Pad app), used by the charting nurse, which provides guidance on pending tasks as the charting nurse enters completed tasks. The Guiding Pad app interfaces with a large liquid crystal display (LCD) screen in the resuscitation room, providing a collaborative platform used to support healthcare providers during management of cardiac arrest - called InterFACE (Interconnected and Focused Mobile Applications in the Patient Care Environment). Integration of the LCD screen allows for display of the cardiac arrest algorithm and a running list of tasks completed, which we anticipate will promote communication and shared situational awareness. When connected to AR devices, the Guiding Pad app allows for role-specific decision support to be shared with the provider wearing the AR device.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Treatment
盲法
None

盲法说明

Masking not possible given the nature of the intervention(s)

入排标准

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

入选标准

  • 未提供

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 epinephrine

时间窗: During event

Time to epinephrine administration, in seconds

次要结局

  • Time to initiation of CPR(During event)
  • Time to amiodarone administration(During event)
  • Time to defibrillation(During event)
  • Time to intubation(During event)
  • Percentage of overall excellent CPR(During event)
  • Medication errors(During event)
  • Pauses in CPR(During event)
  • Percentage compliance for CPR depth(During event)
  • Chest compression fraction(During event)
  • Percentage compliance for CPR rate(During event)
  • Provider workload(Immediately after event)
  • Provider cognitive load(Immediately After event)
  • Teamwork quality(Immediately After event)
  • Peri-shock pause duration(During event)
  • Team leadership quality(Immediately After event)
  • System Usability(Immediately After event)
  • Provider anxiety(Immediately After event)
  • User Experience(Immediately After event)
  • Technology Acceptance(Immediately After event)

研究者

发起方
KidSIM Simulation Program
申办方类型
Network
责任方
Principal Investigator
主要研究者

Adam Cheng

Director, Research and Development

University of Calgary

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