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 @ 12:16 AM
Ignite Modification Date:
2025-12-25 @ 12:16 AM
NCT ID:
NCT02915458
Eligibility Criteria:
Inclusion Criteria:
1\. Patients with mechanical ventilation via an endotracheal tube (oral endotracheal tube or tracheostomy tube) for \>24 hours; 2. Patients are concomitant with presence of the following criteria of ready be weaned, a spontaneous breathing trial (SBT) will then be evaluated by 120-min T-piece:
1. clear improvement of the condition that led to mechanical ventilation;
2. no acute pulmonary or neuromuscular disease or signs of increased intracranial pressure;
3. conscious and lying on a bed with the upper body elevated to a 30◦ angle
4. adequate oxygenation (PaO2 ≥ 60mmHg and fraction of inspired oxygen inspired oxygen fraction (FiO2) ≤ 40% with positive end expiratory pressure (PEEP) ≤ 8cm H2O, or PaO2 /FiO2 \>150 mmHg);
5. no significant respiratory acidosis, PaCO2\<50mmHg, or increasing \<10% for patients with chronic CO2 retention.
6. stable cardiovascular status (Heat beat ≤140/min, systolic blood pressure 90-160mmHg);
7. no requirement for vasopressive or inotropic dugs≥ 8 hours;
8. no intravenous sedatives during the previous 24 hours;
9. ability to cough while suction;
10. afebrile with ≤ 38◦ C temperature.
11. negative cuff leakage test: \>110ml or \>12%
Exclusion Criteria:
1. Presence of tracheostomy
2. Home ventilation prior to ICU admission
3. Decision not to re-intubate or withdrawal of care anticipated
4. Further surgery requiring sedation planned next 48 hours
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02915458
Study Brief:
Protocol Section:
NCT02915458