Passy-Muir Speaking Valve: Stepwise tolerance assessment: 0.5 hour → 4 hours. Decannulation Criteria: Continuous tolerance for 4 hours with stable vital signs, peripheral capillary oxygen saturation(SpO₂) ≥93% (on room air or low-flow oxygen), no significant respiratory distress. If patients in the Capping Group group cannot tolerate continuous catheter occlusion for 48 hours, they are transferred to the Speaking Valve group and undergo a 4-hour voice valve test starting at 0.5 hours.
Tracheostomy tube capping: Gradual capping: 1hour → 48hours. Decannulation Criteria: Continuous tolerance for 48 hours with stable vital signs, SpO₂ ≥93% (on room air or low-flow oxygen), no significant respiratory distress.
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
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).
Primary outcome measure(s)
Decannulation Success Rate — 48 hours post-decannulation Proportion of participants with successful decannulation and no reintubation within 48 hours, based on total randomized participants.
Trial sites (1)
Facility
City
Region
Status
Beijing Rehabilitation Hospital, Capital Medical University
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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