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 @ 4:35 AM
Ignite Modification Date:
2025-12-25 @ 4:35 AM
NCT ID:
NCT04349618
Eligibility Criteria:
Inclusion Criteria:
* Adults aged 18 years or older
* ARDS according to the Berlin definition
* COVID-19 pneumonia confirmed by RT-PCR
* Acute respiratory failure not fully explained by left ventricular failure or sodium overload
* Bilateral pulmonary radiological opacities not fully explained by pleural effusions or atelectasis or nodules
* Invasive mechanical ventilation with PaO2/FiO2 ≤ 150 mm Hg and PEEP ≥ 5 cm H2O with a tidal volume below or equal to 6 ml per kilogram of predicted body weight
* Continuous intravenous sedation as part of ARDS treatment
Exclusion Criteria:
* Exclusion criteria related to ARDS history
* ARDS onset more than 48 hours before inclusion
* previous inclusion in present study
* Exclusion criteria related to ARDS severity or complications
* arterial pH \< 7.21 despite respiratory rate set to 35/min at the time of inclusion
* patient under any extracorporeal CO2 removal technique or ECMO
* pneumothorax or bronchopleural fistula
* Exclusion criteria related to comorbidities
* suspected intracranial hypertension
* severe chronic obstructive pulmonary disease defined by a GOLD score ≥ 3
* chronic respiratory failure under home oxygen or non-invasive ventilation
* chronic respiratory failure requiring long term oxygen or non-invasive ventilation
* obesity with body weight over height ratio greater than 1 kg/cm
* sickle cell disease
* bone marrow transplant \< 6 months
* burn injury with extension greater than 30% of body surface area
* cirrhosis with Child-Pugh score C
* advance directives to withhold or withdraw life sustaining treatment
* Exclusion criteria related to legislation
* Patient under an exclusion period relative to participation to another clinical trial, or inclusion into a clinical trial interfering with the ventilatory strategies
* pregnancy, lactating women
* patient under a legal protective measure.
* lack of affiliation to social security as required by French regulation
* lack of written informed consent by patient or next of kin (unless if recourse to the emergency procedure in the absence of a loved one)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04349618
Study Brief:
Protocol Section:
NCT04349618