Adult Respiratory Distress SyndromePULMODELNCT06835881
Prevention of Lung Injury Induced by Mechanical Ventilation in Acute Respiratory Distress Syndrome ARDS Patients
An observational study of Adult Respiratory Distress Syndrome, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adult Respiratory Distress Syndrome
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2025to Jul 2027
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants or populations are selected based on predefined criteria
Who may be able to join
- Adults ≥ 18 years requiring intensive care hospitalization for moderate-to-severe ARDS defined by a PaO2/FiO2 ratio < 200 mmHg and benefiting from respiratory monitoring including esophageal pressure (EPP) and EIT.
- Patient having been individually informed and not objecting to the re-use of his/her data for research purposes or, where applicable, trusted support person / close relative / parent of patient unable to express his/her wishes.
Who cannot join
- Patient, or where applicable, trusted support person / close relative / parent of patient unable to express his/her wishes, opposed to the re-use of his/her data for research purposes.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
AP-HP, Lariboisière Hospital, Department of Anesthesiology and Intensive Care
Paris, 75010
Joaquim MATEO, MD, 33(0)149958374, joaquim.mateo@aphp.fr
Fabrice VALLEE, MD PhD, +33(0)149958071, fabrice.vallee@gmail.com
About this study
Official title: 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
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.
Read the detailed description
During mechanical ventilation (MV) of patients with acute respiratory distress syndrome (ARDS), the application of the most protective ventilatory strategy possible, based on the reduction of volotrauma and the personalized prescription of a positive end-expiratory pressure (PEEP) regime, is the guarantee of clinical benefit, demonstrated in terms of tidal volume in particular (reduced mortality and number of days without mechanical ventilation).
When a benefit for patients with ARDS is found in clinical trials, it is mainly related to a reduction in the damage caused by mechanical ventilation.
Through technological progress mechanical ventilation optimization is guided by advanced monitoring, including measurement of transpulmonary pressure (TPP or LP) and/or functional imaging data (e.g. Electro-impedance Tomography, EIT).
All these monitoring systems are now incorporated in the new generation of ventilators.
- Transpulmonary pressure (TPP); By estimating trans-pulmonary pressure, investigators can assess pulmonary stress and, without doubt, better interpret critical alveolar opening pressure.
- Continuous measurement of lung pressures and volumes (end-expiratory lung volume, EELV, as a substitute for functional respiratory capacity (FRC)) can also be obtained using more recent techniques based on the study of exhaled CO2 kinetics (volumetric capnography and dynamic capnometry).
- Electro-Impedance Tomography (EIT) ; Electrical impedance tomography (PulmoVista 500 ® , Drager, Germany; or integrated into the respirator, ELISA800VIT® , Lowenstein, Germany) provides totally non-invasive, cross-sectional visualization of part of pulmonary aeration, both dynamically and regionally.
This observational study on clinical physiological data is based on the reuse of pseudonymized recorded data in 1st-line care during sequential diagnostic maneuvers based on calibrated variations in PEEP and tidal volume and obtained by advanced respiratory monitoring in the acute phase of ARDS (esophageal manometry and/or EIT) and in accordance with the most recent recommendations.
No specific research procedures are planned for this study. This study will be conducted exclusively on the basis of personal data collected as part of the usual monitoring of a participant with ARDS undergoing advanced respiratory care. The analysis focuses on data recorded during recruitment maneuvers performed as part of care for this type of patient in the ICU.
Participants are informed individually, and their non-objection to the re-use of their data for research purposes is recorded in the file. Where applicable, information is given to the trusted support person/relative/parent if the participant is unable to express his/her wishes and does not object to the re-use of his/her data for research purposes. An information note is given to the patient or the trusted support person/relative/parent
Monitoring data is currently available in the Clinical Research Unit of our Intensive Care Departments, thanks to a data extraction system based on PHILIPS IntelliVue® or Mindray Benevision® monitoring solutions. It should be noted that the Data Warehouse Connect software solution enables all these data to be collected with fine sampling (2 ms for tracings, 1s for digital data), considerably extending the capabilities in terms of data analysis and exploitation. The extraction system is temporally coupled to patient events and medication (doses) administered, thanks to an IntelliSpace Critical Care and Anesthesia (ICCAA) information system that is operational in the ICU.
These data are downloaded onto a secure server with restricted access, then loaded into a database (SQL) for future processing of the pseudonymized data.
The data will be collected as part of routine care and is integrated in compliance with the RGPD.
Demographic data will be collected using the intensive care record (ORBIS or equivalent / computerized patient record).
Aim of the study Does the analysis of advanced monitoring data provide characteristic measured parameters that could help prevent or even reduce ventilator-induced lesions? Can these data be integrated into a model to build a digital twin for practical, simplified monitoring of ventilatory function?
- Conditions
- Adult Respiratory Distress Syndrome
- Keywords
- Ventilator optimization, Ventilator induced lung injury, Digital twin, Smart data
- Medical subject headings
- Respiratory Distress Syndrome, Ventilator-Induced Lung Injury
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Acquisition and recording of monitoring data up to 5 days of intensive care in the acute phase of ARDS.
Secondary outcomes (3)
Describe and a posteriori analyze the data recorded and establish a relationship between aeration gain and gas exchange.
Ventilation/pulmonary perfusion (in %) obtained with the Electro-Impedance Tomography (EIT) data
Measured: 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.
- Transpulmonary pressure (TPP) (in cmH2O)
Measured: 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).
- Pulmonary stress (mL/cmH2O)
Measured: Acquisition and recording of monitoring data up to 5 days of intensive care in the acute phase of ARDS.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2025
- Study startJun 2025 (estimated)
- Primary completionJun 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adult Respiratory Distress SyndromeStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- INSERM UMR-942, Paris, France, M3DISIM
- Responsible party
- Sponsor
- Investigators
- Joaquim MATEO, MD, Study director, Assistance Publique - Hôpitaux de ParisFabrice VALLEE, MD PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06835881
- Sponsor's protocol ID
- APHP241678
- Acronym
- PULMODEL
- Status last verified
- Apr 2025
- First submitted
- 9 Jan 2025
- Last updated
- 24 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06835881
- Acronym / sponsor ID
- PULMODEL / APHP241678
- Conditions
- Adult Respiratory Distress Syndrome
- Keywords
- Ventilator optimization, Ventilator induced lung injury, Digital twin, Smart data
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- INSERM UMR-942, Paris, France, M3DISIM
- Study start
- Jun 2025 (estimated)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 19 Feb 2025 (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.
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.
Detailed description
During mechanical ventilation (MV) of patients with acute respiratory distress syndrome (ARDS), the application of the most protective ventilatory strategy possible, based on the reduction of volotrauma and the personalized prescription of a positive end-expiratory pressure (PEEP) regime, is the guarantee of clinical benefit, demonstrated in terms of tidal volume in particular (reduced mortality and number of days without mechanical ventilation).
When a benefit for patients with ARDS is found in clinical trials, it is mainly related to a reduction in the damage caused by mechanical ventilation.
Through technological progress mechanical ventilation optimization is guided by advanced monitoring, including measurement of transpulmonary pressure (TPP or LP) and/or functional imaging data (e.g. Electro-impedance Tomography, EIT).
All these monitoring systems are now incorporated in the new generation of ventilators.
- Transpulmonary pressure (TPP); By estimating trans-pulmonary pressure, investigators can assess pulmonary stress and, without doubt, better interpret critical alveolar opening pressure.
- Continuous measurement of lung pressures and volumes (end-expiratory lung volume, EELV, as a substitute for functional respiratory capacity (FRC)) can also be obtained using more recent techniques based on the study of exhaled CO2 kinetics (volumetric capnography and dynamic capnometry).
- Electro-Impedance Tomography (EIT) ; Electrical impedance tomography (PulmoVista 500 ® , Drager, Germany; or integrated into the respirator, ELISA800VIT® , Lowenstein, Germany) provides totally non-invasive, cross-sectional visualization of part of pulmonary aeration, both dynamically and regionally.
This observational study on clinical physiological data is based on the reuse of pseudonymized recorded data in 1st-line care during sequential diagnostic maneuvers based on calibrated variations in PEEP and tidal volume and obtained by advanced respiratory monitoring in the acute phase of ARDS (esophageal manometry and/or EIT) and in accordance with the most recent recommendations.
No specific research procedures are planned for this study. This study will be conducted exclusively on the basis of personal data collected as part of the usual monitoring of a participant with ARDS undergoing advanced respiratory care. The analysis focuses on data recorded during recruitment maneuvers performed as part of care for this type of patient in the ICU.
Participants are informed individually, and their non-objection to the re-use of their data for research purposes is recorded in the file. Where applicable, information is given to the trusted support person/relative/parent if the participant is unable to express his/her wishes and does not object to the re-use of his/her data for research purposes. An information note is given to the patient or the trusted support person/relative/parent
Monitoring data is currently available in the Clinical Research Unit of our Intensive Care Departments, thanks to a data extraction system based on PHILIPS IntelliVue® or Mindray Benevision® monitoring solutions. It should be noted that the Data Warehouse Connect software solution enables all these data to be collected with fine sampling (2 ms for tracings, 1s for digital data), considerably extending the capabilities in terms of data analysis and exploitation. The extraction system is temporally coupled to patient events and medication (doses) administered, thanks to an IntelliSpace Critical Care and Anesthesia (ICCAA) information system that is operational in the ICU.
These data are downloaded onto a secure server with restricted access, then loaded into a database (SQL) for future processing of the pseudonymized data.
The data will be collected as part of routine care and is integrated in compliance with the RGPD.
Demographic data will be collected using the intensive care record (ORBIS or equivalent / computerized patient record).
Aim of the study Does the analysis of advanced monitoring data provide characteristic measured parameters that could help prevent or even reduce ventilator-induced lesions? Can these data be integrated into a model to build a digital twin for practical, simplified monitoring of ventilatory function?
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants or populations are selected based on predefined criteria
Key inclusion criteria (2 listed)
- Adults ≥ 18 years requiring intensive care hospitalization for moderate-to-severe ARDS defined by a PaO2/FiO2 ratio < 200 mmHg and benefiting from respiratory monitoring including esophageal pressure (EPP) and EIT.
- Patient having been individually informed and not objecting to the re-use of his/her data for research purposes or, where applicable, trusted support person / close relative / parent of patient unable to express his/her wishes.
Key exclusion criteria (1 listed)
- Patient, or where applicable, trusted support person / close relative / parent of patient unable to express his/her wishes, opposed to the re-use of his/her data for research purposes.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Time frame: Acquisition and recording of monitoring data up to 5 days of intensive care in the acute phase of ARDS.
- PEEP levels (cmH2O)
3 secondary outcomes
Describe and a posteriori analyze the data recorded and establish a relationship between aeration gain and gas exchange.
Time frame: 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.
Time frame: 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).
Time frame: Acquisition and recording of monitoring data up to 5 days of intensive care in the acute phase of ARDS.
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 24 Apr 2025.
- Individual participant dataSharing planned: No
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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.
Joaquim MATEO, MD study director
Assistance Publique - Hôpitaux de Paris
Fabrice VALLEE, MD PhD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adult Respiratory Distress Syndrome, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 2 inclusion and 1 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 24 Apr 2025. 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 France. 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 Joaquim MATEO, MD (+33(0)149958374, joaquim.mateo@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: Acquisition and recording of monitoring data up to 5 days of intensive care in the acute phase of ARDS.). 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 24 Apr 2025.