Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310029, China
NCT Number: NCT07511712
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.
Trial opening soon.
Get Notified18 year–65 year
All sexes
Interventional
Not applicable
Hangzhou, Zhejiang, 310029, China
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
This intervention consists of a high-fidelity graphical display that translates raw simulator data into synchronized 3D animations and advanced physiological waveforms. It provides continuous visualization of, Muscle Pressure (Pmus), and the Equation of Motion components (Resistive vs. Elastic pressure) to assist in clinical diagnosis.
This intervention represents the current standard of care in mechanical ventilation monitoring. Clinicians are limited to the pressure-time and flow-time waveforms provided by the mechanical ventilator interface. Diagnostic assessments of lung mechanics (Resistance and Compliance) must be performed using manual ventilator maneuvers, such as inspiratory and expiratory holds.
Time frame: 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.
Time frame: From the onset of the simulated respiratory crisis until the participant verbalizes the correct diagnosis, assessed during each 10-minute simulation scenario.
The duration (in seconds) from the initiation of a respiratory crisis (T=120s) until the participant accurately identifies the underlying pathophysiology (e.g., Bronchospasm, Atelectasis, Auto-PEEP, or Double Triggering). This is measured by an independent observer using a synchronized stopwatch. Lower times indicate higher diagnostic efficiency.
Time frame: Assessed at the conclusion of each 10-minute simulation scenario.
The percentage of participants who correctly identify the respiratory complication within the allotted 10-minute scenario time. A diagnosis is marked "Correct" or "Incorrect" based on pre-defined criteria for each of the four scenarios.
Contact information is provided by the study sponsor or research team.
Second Affiliated Hospital, School of Medicine, Zhejiang University
Other
Effect of Real-Time Respiratory Mechanics Visualization ("Digital Twin") on Clinician Cognitive Workload and Diagnostic Latency: A Randomized Crossover Simulation Trial
Acronym: VERDICT
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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