Comparison of Speaking Valve Trial and Capping Trial for Tracheostomy Decannulation in Stroke Pat… (NCT07435727) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Comparison of Speaking Valve Trial and Capping Trial for Tracheostomy Decannulation in Stroke Patients
China120 participantsStarted 2026-04-01
Plain-language summary
This study aims to compare the efficacy and safety of the Speaking Valve trial versus the traditional Capping trial as indicators for tracheostomy decannulation in stroke patients. The trial is a prospective, multicenter, randomized, parallel-group, outcomes-assessor-blinded study with an exploratory crossover design.
Who can participate
Age range18 Years – 80 Years
SexALL
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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, SpOâ‚‚ \<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).