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:
2025-12-24 @ 11:45 PM
Ignite Modification Date:
2025-12-24 @ 11:45 PM
NCT ID:
NCT02713451
Eligibility Criteria:
Inclusion Criteria:
* Major patients with mechanical ventilation
* ARDS according to Berlin definition:Hypoxemia defined with PaO2 FiO2 ratio less or equal to 300 mmHg with Positive End Expiratory Pressure higher or equal to 5 cmH20, Less than seven days between a known clinical insult or new or worsening of respiratory symptoms, Bilateral opacities on chest Imaging not fully explained by effusions, lobar or lung collapse, or nodules, Respiratory failure not fully explained by cardiac failure or fluid overload
* Less than twelve hours following initiation of mechanical ventilation.
Exclusion Criteria:
* Pregnancy
* Patient less than 18 years old
* Sickle cell disease
* Patient deprived of freedom, Under a legal protective measure
* Cardiac arrest as the reason for ICU hospitalisation
* Traumatic brain injury as the reason for ICU hospitalisation
* Hemoptysis with embolization or surgery
* Extracorporeal life support or Extracorporeal Membrane Oxygenation before randomization
* Chronic Obstructive Pulmonary Disease with oxygen or non invasive ventilation at home (obstructive sleep apnoea syndrome is not an exclusion criteria)
* Patient with very high risk of death with IGS II (Simplified Severity Index II) than 90
* Indication of hyperbaric oxygenation : carbon monoxide intoxication, gas embolism, necrotizing fasciitis
* Cyanide intoxication, methemoglobinemia
* Untreated pneumothorax
* Lymphangitis carcinomatosa
* Eosinophilic pneumonia
* Intensive care management for organ donation
* Participation in another interventional study with mortality as a major outcome to avoid confounding factor
* Patient not affiliated to social security
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02713451
Study Brief:
Protocol Section:
NCT02713451