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 @ 1:46 AM
Ignite Modification Date:
2025-12-25 @ 1:46 AM
NCT ID:
NCT05719194
Eligibility Criteria:
Inclusion Criteria : all patients ≥ 18 y.o admitted to the ICU, under invasive mechanical ventilation for more then 24 hours and fullfilling the following weaning criteria :
* Resolution or improvement of the condition that led to intubation, as judged by the clinician in charge of the patient.
* Hemodynamic stability, defined as systolic blood pressure between 90 and 160 mmHg, heart rate less than 140 beats/min, without or with low doses of vasopressors.
* Glasgow score of 13 or greater and Richmond Agitation-Sedation Scale (RASS) score between -1 and +1.
* Respiratory stability defined as: oxygen saturation \> 90% with inspired oxygen fraction ≤ 0.5 and PEEP ≤ 8 cmH2O, respiratory rate \< 35/min, spontaneous tidal volume \> 5 mL/kg, and peak inspiratory pressure ≤ 15 cmH2O.
* Few secretions (\< 3 aspirations in the past 8 hours).
* Effective cough.
* Negative leak test (\>100 mL or \>10%).
* No surgery planned within 72 hours.
* Patients with a social security plan.
Exclusion Criteria:
* Acute cerebral pathology requiring admission to intensive care and/or mechanical ventilation with tracheal intubation for neurological reasons (Glasgow score \<13 at the time of intubation or CT scan abnormality): hemorrhagic stroke without or with vascular malformation (aneurysm, arterio-venous malformation...), ischemic stroke, head trauma, cerebral anoxo-ischemia after cardiac arrest.
* Tetraplegic or paraplegic patients with lesion level higher than D8.
* Peripheral neuromuscular pathology (underlying myopathy or myasthenia).
* ICU's Neuromyopathy.
* Tracheostomy.
* Patients with a decision of non-reintubation or terminal intubation.
* Pregnant or lactating women.
* Patients already included in this study.
* Patients under guardianship, curatorship or safeguard of justice.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05719194
Study Brief:
Protocol Section:
NCT05719194