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 @ 4:17 AM
Ignite Modification Date:
2025-12-25 @ 4:17 AM
NCT ID:
NCT04014920
Eligibility Criteria:
Inclusion Criteria:
* Adult (age ≥ 18 years)
* Subjects must be covered by public health insurance
* Obese patients defined by a body mass index ≥ 30 kg/m²
* Extubation after a length of mechanical ventilation \>= 6 hours
* Written informed consent from the patient or proxy (if present) before inclusion or once possible when patient has been included in a context of emergency.
Exclusion Criteria:
* Refusal of study participation or to pursue the study by the patient
* Hypercapnia with a formal indication for NIV (PaCO2 ≥ 50 mmHg, formal indication for NIV)
* Isolated cardiogenic pulmonary edema (formal indication for NIV). Patients with pulmonary edema associated with another ARF etiology can be included.
* Pregnancy or breastfeeding
* Anatomical factors precluding the use of NIV and/or HFNO
* Absence of coverage by the French statutory healthcare insurance system
* Patients with tracheostomy
* Patients with CPAP for obstructive apnea syndrome
* Patients with decision of no-reintubate (limitation)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04014920
Study Brief:
Protocol Section:
NCT04014920