- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07511712
Using Real-Time Lung Visuals to Reduce Mental Strain and Improve Diagnosis Speed (VERDICT)
Effect of Real-Time Respiratory Mechanics Visualization ("Digital Twin") on Clinician Cognitive Workload and Diagnostic Latency: A Randomized Crossover Simulation Trial
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.
Study Overview
Status
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Reng Ren, M.D.
- Phone Number: 086-13486111524
- Email: renreng1203@zju.edu.cn
Study Locations
-
-
Zhejiang
-
Hangzhou, Zhejiang, China, 310029
- Second Affiliated Hospital of Zhejiang University School of Medicine
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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.
|
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.
|
|
Active Comparator: 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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Perceived Mental Workload (NASA Task Load Index)
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.
|
Within 5 minutes following the completion of each 10-minute simulation scenario.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Time to Correct Diagnosis (Diagnostic Latency)
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.
|
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
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.
|
Assessed at the conclusion of each 10-minute simulation scenario.
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20260530
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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