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 @ 3:55 AM
Ignite Modification Date:
2025-12-25 @ 3:55 AM
NCT ID:
NCT06724302
Eligibility Criteria:
Inclusion Criteria:
* Patients will be enrolled if they are ≥18 years old, on invasive mechanical ventilation (MV) for more than 48 h and are eligible for first spontaneous breathing trial (SBT) after fulfilling all the following criteria:
1. Resolution or improvement of the disease leading to MV.
2. Adequate oxygenation, indicated by arterial oxygen partial pressure to inspired oxygen fraction (PaO2/FiO2) ≥ 200 mmHg, both with positive end-expiratory pressure (PEEP) ≤ 5 cmH2O and rapid shallow breathing index\< 105.
3. Adequate pulmonary function, indicated by a RR\<30 breaths/min with VT ≥5 mL/kg ideal body weight (IBW) and no significant respiratory acidosis with normal serum electrolytes.
4. Stable hemodynamics status, without or with minimal vasopressors
5. Conscious and cooperative patient
6. Absence of excessive tracheobronchial secretion (\<3 times suction in the past 8 hours).
7. Effective cough reflex .Exclusion Criteria:
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1. Pregnancy.
2. Presence of tracheostomy, pleural effusion, pneumothorax, pneumomediastinum, or hemothorax.
3. Presence of rib fractures.
4. Pre-existing cervical spinal injury, history or final diagnosis of neuromuscular disorders, and diaphragmatic paralysis or disorders
5. Use of neuromuscular blocking agents within 48 hours.
6. A distorted abdominal wall anatomy, or damage to the abdominal wall.
7. Patients with localized fluid collections in the abdomen, hernias, abdominal wall hematomas, inguinal masses, femoral hernias, abdominal surgeries.
8. BMI≥ 40
9. Patients with previously failed SBT
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06724302
Study Brief:
Protocol Section:
NCT06724302