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Comparison of Speaking Valve Trial and Capping Trial for Tracheostomy Decannulation in Stroke Patients
Sponsor: Hongying Jiang, MD
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.
Official title: Comparison of Speaking Valve Trial and Capping Trial in the Decannulation Process for Stroke Patients: A Randomized, Controlled, Multicenter Study
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
120
Start Date
2026-04-01
Completion Date
2027-07-01
Last Updated
2026-02-27
Healthy Volunteers
No
Conditions
Interventions
Passy-Muir Speaking Valve
Stepwise tolerance assessment: 0.5 hour → 4 hours. Decannulation Criteria: Continuous tolerance for 4 hours with stable vital signs, SpO₂ ≥93% (on room air or low-flow oxygen), no significant respiratory distress.
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.
Locations (1)
Beijing Rehabilitation Hospital, Capital Medical University
Beijing, Beijing Municipality, China