Effect of Real-Time Respiratory Mechanics Visualization ("Digital Twin") on Clinician Cognitive Workload and Diagnostic Latency: A Randomized Crossover Simulation Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Perceived Mental Workload (NASA Task Load Index)
研究概览
简要总结
The goal of this clinical simulation study is to learn if a "Digital Twin" graphical lung display reduce the mental workload of clinicians. The study also evaluates if this helps physicians diagnose and manage ventilator-related crises more effectively than standard ventilator screens.
The main questions it aims to answer are:
Does the Digital Twin display lower the cognitive stress (mental workload) experienced by clinicians during a crisis? Does the Digital Twin display reduce the time it takes for clinicians to identify specific respiratory complications? Does the use of real-time physiological visualization improve the accuracy of clinical decision-making? Researchers will compare the performance of clinicians using a standard ventilator display (the "Black Box" condition) to their performance when provided with an additional synchronized 3D lung and advanced waveform display (the "Digital Twin" condition).
Participants will:
Complete four randomized mechanical ventilation crisis scenarios using a high-fidelity lung simulator (ASL 5000).
Manage scenarios involving high airway resistance, low lung compliance, auto-PEEP, and patient-ventilator asynchrony.
Undergo a 14-day "washout" period between sessions to ensure no memory bias between the control and intervention groups.
Complete a NASA-TLX survey after each scenario to measure their perceived mental, physical, and temporal demand.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Licensed physicians currently practicing in intensive care units (ICU), neuro-intensive care units (NICU), or respiratory departments.
- •For the Junior Stratum: Physicians currently in a standardized residency training program or in their first two years of a sub-specialty fellowship. For the Senior Stratum: Senior attending physicians or senior fellows with more than 5 years of experience in intensive care medicine.
- •Basic proficiency in operating the mechanical ventilators used in the study (e.g., Hamilton, Dräger, or Puritan Bennett).
- •Willingness to participate in two simulation sessions separated by a 14-day interval.
排除标准
- •Prior formal training or significant experience using the ASL 5000 / RespiSim "Digital Twin" or Aurora interface.
- •Physical limitations that prevent the operation of a mechanical ventilator or the viewing of a digital monitor.
- •Refusal to provide informed consent for video recording of the simulation session for data adjudication.
研究组 & 干预措施
Digital Twin Intervention Group
Participants in this arm are provided with a "Digital Twin" visualization in addition to the standard ventilator display. This includes a secondary monitor displaying the RespiSim interface, featuring a synchronized 3D lung model (RespiView) and advanced physiological waveforms (Muscle Pressure, and the Equation of Motion parameters). Participants manage four simulated mechanical ventilation crises where the underlying pathophysiology is visually represented in real-time.
干预措施: Real-time Graphical Lung Function Visualization (Digital Twin) (Device)
Standard Monitoring Control Group (Black Box)
Participants in this arm manage the same four simulated mechanical ventilation crises using only the information available on a standard mechanical ventilator display (e.g., airway pressure and flow-time waveforms). The secondary "Digital Twin" monitor is deactivated. Participants must rely on traditional clinical assessment and manual ventilator maneuvers (such as inspiratory and expiratory holds) to diagnose and manage the respiratory complications.
干预措施: Standard Ventilator Waveform Monitoring (Other)
结局指标
主要结局
Perceived Mental Workload (NASA Task Load Index)
时间窗: Within 5 minutes following the completion of each 10-minute simulation scenario.
The total workload score as measured by the NASA Task Load Index (NASA-TLX). This validated tool assesses six dimensions: mental demand, physical demand, temporal demand, performance, effort, and frustration level. Each dimension is scored on a scale of 0 to 100. The weighted average provides a "Global Workload Score." Higher scores represent a higher perceived cognitive burden.
次要结局
- Time to Correct Diagnosis (Diagnostic Latency)(From the onset of the simulated respiratory crisis until the participant verbalizes the correct diagnosis, assessed during each 10-minute simulation scenario.)
- Diagnostic Accuracy Rate(Assessed at the conclusion of each 10-minute simulation scenario.)
研究者
Ren Reng
Principal investigator
Second Affiliated Hospital, School of Medicine, Zhejiang University