Using Real-Time Lung Visuals to Reduce Mental Strain and Improve Diagnosis Speed

NCT07511712 | Not Yet Recruiting DMC

• 1 other identifier: 20260530
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Mechanical Ventilation; Clinical Competence; Education Curriculum; Self Concept

Keywords

medical simulation; mechanical ventilation; clinical competence; mental pressure load

Outcome Measures

Primary Outcomes (1)

• 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.

  Within 5 minutes following the completion of each 10-minute simulation scenario.

Secondary Outcomes (2)

• 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.

Study Arms (2)

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.

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.

Other: Standard Ventilator Waveform Monitoring

Interventions

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.

Digital Twin Intervention Group

Standard Ventilator Waveform Monitoring OTHER

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.

Standard Monitoring Control Group (Black Box)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

Second Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310029, China

Location

Central Study Contacts

Reng Ren, M.D.

CONTACT

086-13486111524; renreng1203@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: March 30, 2026
• First Posted: April 6, 2026
• Study Start: April 15, 2026
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)