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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.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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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.

Joaquim MATEO, MD contact

+33(0)149958374

joaquim.mateo@aphp.fr

Fabrice VALLEE, MD PhD contact

+33(0)149958071

fabrice.vallee@gmail.com

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

Other trials in France

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?

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.

  1. 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)
  1. 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

  2. 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.

  3. 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.

  1. First posted19 Feb 2025
  2. Study startJun 2025 (estimated)
  3. Primary completionJun 2027 (estimated)
  4. Study completionJul 2027 (estimated)

Resources

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)
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

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.

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