Mechanical VentilationVERDICTNCT07511712
Using Real-Time Lung Visuals to Reduce Mental Strain and Improve Diagnosis Speed
A study testing Real-time Graphical Lung Function Visualization (Digital Twin) and Standard Ventilator Waveform Monitoring in people with Mechanical Ventilation and Clinical Competence, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Mechanical Ventilation, Clinical Competence, Education Curriculum
- What is being tested?
- Real-time Graphical Lung Function Visualization (Digital Twin) and Standard Ventilator Waveform Monitoring
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteChina
- Study dates
- 15 Apr 2026to 31 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310029
About this study
Official title: 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:
Read more
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.
- Being tested
- Real-time Graphical Lung Function Visualization (Digital Twin), Standard Ventilator Waveform Monitoring
- Keywords
- medical simulation, mechanical ventilation, clinical competence, mental pressure load
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Real-time Graphical Lung Function Visualization (Digital Twin)Device
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.
Standard Ventilator Waveform MonitoringOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Digital Twin Intervention Group | Experimental | 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. Receives: Device: Real-time Graphical Lung Function Visualization (Digital Twin) |
| Standard Monitoring Control Group (Black Box) | Active comparator | 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. Receives: Other: Standard Ventilator Waveform Monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perceived Mental Workload (NASA Task Load Index)
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.
Measured: Within 5 minutes following the completion of each 10-minute simulation scenario.
Secondary outcomes (2)
Time to Correct Diagnosis (Diagnostic Latency)
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.
Measured: 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
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.
Measured: Assessed at the conclusion of each 10-minute simulation scenario.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2026
- Study start15 Apr 2026 (estimated)
- Primary completion31 Jul 2026 (estimated)
- Study completion31 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mechanical VentilationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ren Reng, Second Affiliated Hospital, Zhejiang University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07511712
- Sponsor's protocol ID
- 20260530
- Acronym
- VERDICT
- Status last verified
- Apr 2026
- First submitted
- 30 Mar 2026
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (including diagnostic latency times and NASA-TLX scores) will be made available upon reasonable request to qualified researchers for the purpose of meta-analysis or replication of results.
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Real-Time Respiratory Mechanics Visualization ("Digital Twin") on Clinician Cognitive Workload and Diagnostic Latency: A Randomized Crossover Simulation Trial
- ClinicalTrials.gov ID
- NCT07511712
- Acronym / sponsor ID
- VERDICT / 20260530
- Keywords
- medical simulation, mechanical ventilation, clinical competence, mental pressure load
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 15 Apr 2026 (estimated)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 31 Jul 2026 (estimated)
- First posted
- 6 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Digital Twin Intervention Group | Experimental | Device: Real-time Graphical Lung Function Visualization (Digital Twin)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. |
| Standard Monitoring Control Group (Black Box) | Active comparator | Other: Standard Ventilator Waveform MonitoringParticipants 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Real-time Graphical Lung Function Visualization (Digital Twin)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. | Device | Digital Twin Intervention Group |
| Standard Ventilator Waveform MonitoringThis 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. | Other | Standard Monitoring Control Group (Black Box) |
Primary outcome
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.
2 secondary outcomes
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.
Diagnostic Accuracy Rate
Time frame: Assessed at the conclusion of each 10-minute simulation scenario.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (including diagnostic latency times and NASA-TLX scores) will be made available upon reasonable request to qualified researchers for the purpose of meta-analysis or replication of results.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Real-time Graphical Lung Function Visualization (Digital Twin) and Standard Ventilator Waveform Monitoring in people with Mechanical Ventilation and Clinical Competence, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Reng Ren, M.D. (086-13486111524, renreng1203@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perceived Mental Workload (NASA Task Load Index) (time frame: Within 5 minutes following the completion of each 10-minute simulation scenario.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026; AzTrials last refreshed its copy on 27 Oct 2026.