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:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-26 @ 3:20 PM
NCT ID:
NCT07435727
Eligibility Criteria:
Inclusion Criteria:
Stroke (ischemic or hemorrhagic) with subsequent tracheostomy. Stable stage of stroke: clinically in the post-acute or sequelae stage, with stable vital signs, resolved cerebral edema, normalized intracranial pressure, no new neurological deficits.
Clinically stable, defined as: ventilator-free for ≥48 hours prior to enrollment; stable vital signs (temperature \<38°C, heart rate 60-100 bpm, respiratory rate \<20/min, systolic BP 90-160 mmHg); no active severe infection requiring IV antibiotics; no organ failure; PaCO₂ \<60 mmHg.
Peak Cough Flow (PCF) ≥100 L/min. 24-hour subglottic secretion volume \<20 ml. Signed informed consent by patient or legal representative.
Exclusion Criteria:
Intolerance to cuff deflation: severe cough, dyspnea, SpO₂ \<93% (on supplemental oxygen), or respiratory rate \>20/min for \>5 minutes.
Severe airway structural abnormalities: tracheal stenosis (\>50% lumen occlusion confirmed by CT or bronchoscopy), tracheoesophageal fistula.
Life expectancy \<2 weeks or planned transfer to a non-participating institution within 2 weeks.
Severe uncontrolled neurological or systemic diseases (e.g., advanced cancer, severe heart failure).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT07435727
Study Brief:
Protocol Section:
NCT07435727