PULMODEL
Exploratory Study on the Value of Advanced Respiratory Monitoring Data During Mechanical Ventilation in Patients With Acute Respiratory Distress Syndrome (ARDS) in Terms of (1) Estimating the Risk of Ventilator Induced Lung Injury (VILI) and (2) the Relationship Between Aeration Benefit and Gas Exchange
Sponsor study identifier
observational
30
1 country
1
Study Start
June 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
June 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
July 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Given the huge volume of mechanically ventilated patients at risk of ARDS, optimizing hematosis by limiting pulmonary and systemic aggression associated with artificial ventilation techniques is a key objective if we are to further improve the prognosis of ARDS. With a view to improving cardiopulmonary monitoring in ARDS, modeling using digital twins individualized by nature should ultimately enrich the diagnostic approach by simplifying the technical set-up. Advances in modeling in terms of speed, rendering and results could be applied to personalized monitoring to find the right artificial ventilation setting for the right patient, at the right time.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 9, 2025
Actual (reported)February 19, 2025
Actual (reported)June 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
June 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
July 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Describe and a posteriori analyze the recorded data and establish a relationship between the biomechanical characteristics of the data ("air" compartment, stress and strain) and the risk of mechanical ventilation-induced lesions (MVIL) in ARDS patients.
\- PEEP levels (cmH2O)
Acquisition and recording of monitoring data up to 5 days of intensive care in the acute phase of ARDS.
Describe and a posteriori analyze the data recorded and establish a relationship between aeration gain and gas exchange.
Acquisition and recording of monitoring data up to 5 days of intensive care in the acute phase of ARDS
Use part of the collected data to customize a continuously calibrated integrative biomechanical model of the cardiopulmonary system to create a digital twin of the patient.
Acquisition and recording of monitoring data up to 5 days of intensive care in the acute phase of ARDS.
Stratify physiological data according to the main phenotypes determining respiratory mechanics, or endotypes of interest, for a personalized approach to ventilator settings (active and passive phases).
Acquisition and recording of monitoring data up to 5 days of intensive care in the acute phase of ARDS.
Participants or populations are selected based on predefined criteria
AP-HP, Lariboisière Hospital, Department of Anesthesiology and Intensive Care
Paris, 75010, France
Joaquim MATEO, MD
Assistance Publique - Hôpitaux de Paris
Fabrice VALLEE, MD PhD
Assistance Publique - Hôpitaux de Paris
First Submitted
January 9, 2025
First Posted
February 19, 2025
Study Start
June 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
June 2027
EstimatedContact the study team to confirm eligibility.
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
July 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
April 24, 2025
Record last verified: 2025-04
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