Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:21 AM
Ignite Modification Date:
2025-12-25 @ 12:21 AM
NCT ID:
NCT06322758
Eligibility Criteria:
Inclusion Criteria:
* Age \> 18 years
* Invasive mechanical ventilation
* Criteria for ARDS according to Berlin definition:
* Bilateral infiltrates not fully explained by effusions, lobar/lung collapse, or nodules;
* PaO2/FiO2 of 300 or less measured with a PEEP of at least 5 cm H2O
* Respiratory failure not fully explained by cardiac failure or fluid overload These criteria must be observed for less than 72h
* Affiliation to the social security system
* Written consent obtained from the patients (from a support person, family member or a close relative if the patient is not able to expressing and sign consent) or inclusion without initial consent in case of emergency, if the patient is not able to express his/her consent and in the absence of support person, family member or a close relative
Exclusion Criteria:
* Known pregnancy
* Lung transplantation
* Evident significant decrease in chest wall compliance (e.g., abdominal compartment syndrome)
* Moribund patient not expected to survive 24 hours
* Presence of an advanced directive to withhold life-sustaining treatment or decision to withhold life-sustaining treatment
* Chronic respiratory disease requiring home oxygen therapy or ventilation
* ECMO before inclusion
* Pneumothorax
* Enrollment in an interventional ARDS trial with direct impact on VT
* Subject deprived of freedom, subject under a legal protective measure (guardianship/curatorship)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06322758
Study Brief:
Protocol Section:
NCT06322758