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Comparison of Speaking Valve Trial and Capping Trial for Tracheostomy Decannulation in Stroke Patients

RecruitingNAAges 18 Years - 80 YearsAllHongying Jiang, MD
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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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What it tests

  • Passy-Muir Speaking Valve
  • Tracheostomy tube capping
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Where

1 site
Beijing Rehabilitation Hospital, Capital Medical University
Beijing, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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