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 @ 12:44 AM
Ignite Modification Date:
2025-12-25 @ 12:44 AM
NCT ID:
NCT06923267
Eligibility Criteria:
Inclusion Criteria:
* Intubated patient undergoing invasive mechanical ventilation for at least 24 hours and scheduled for a spontaneous breathing trial
* Richmond Agitation Sedation Scale (RASS) between -1 and +1
* Patient at high risk of re-intubation with at least one of the following criteria:
* Underlying cardiac disease (left ventricular dysfunction with left ventricular ejection fraction ≤ 45%, documented ischemic heart disease, chronic atrial fibrillation, known history of cardiogenic pulmonary edema)
* Underlying respiratory disease (COPD, Emphysema, bronchial dilatation, asthma, obesity/hypoventilation syndrome, restrictive lung disease)
Exclusion Criteria:
* Neuromuscular pathology (myasthenia type) preceding hospitalization
* Pregnant or breast-feeding women
* Patient already included in the study
* Protected person (under guardianship or curatorship)
* Person under court protection
* Person not affiliated to a social security scheme
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06923267
Study Brief:
Protocol Section:
NCT06923267