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.
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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…
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 blood pressure 90-160 mmHg); no active severe infection requiring IV antibiotics; no organ failure; partial pressure of Carbon Dioxide(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 Computed Tomography 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).
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