Prevention of Lung Injury Induced by Mechanical Ventilation in Acute Respiratory Distress Syndrome ARDS Patients

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAssistance Publique - Hôpitaux de Paris

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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 population

Participants or populations are selected based on predefined criteria

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

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)

Time frame
Acquisition and recording of monitoring data up to 5 days of intensive care in the acute phase of ARDS.

Secondary outcomes

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

Time frame
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)

Time frame
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)

Time frame
Acquisition and recording of monitoring data up to 5 days of intensive care in the acute phase of ARDS.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Assistance Publique - Hôpitaux de Paris

Lead sponsor

INSERM UMR-942, Paris, France

Collaborator

M3DISIM

Collaborator

This trial is not recruiting at the moment. You can still explore other options: