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.
Stroke survivors may develop disorders of consciousness, dysphagia, and airway dysfunction, with some requiring tracheostomy for prolonged mechanical ventilation or airway protection. Prolonged tracheostomy tube placement can lead to complications such as infection, tracheal stenosis, and communication difficulties. Timely and safe decannulation is crucial for rehabilitation. While the capping trial (typically 48-72 hours) is widely used, the speaking valve offers potential advantages by restoring physiological airflow and facilitating communication. This trial will systematically compare these two methods to provide evidence for optimizing decannulation protocols.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
120
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.
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.
Beijing Rehabilitation Hospital, Capital Medical University
Beijing, Beijing Municipality, China
RECRUITINGDecannulation Success Rate
Proportion of participants with successful decannulation and no reintubation within 48 hours, based on total randomized participants.
Time frame: 48 hours post-decannulation
Time to Decannulation
Number of days from randomization to successful decannulation.
Time frame: From randomization to decannulation, assessed up to 30 days
Pneumonia Incidence at 30 Days
Proportion of decannulated participants diagnosed with pneumonia within 30 days
Time frame: 30 days post-decannulation
Reintubation Rate at 90 Days
Proportion of participants requiring reintubation within 90 days
Time frame: 90 days post-decannulation
Mortality Rate at 90 Days
All-cause mortality within 90 days
Time frame: 90 days post-decannulation
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