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| Name | Class |
|---|---|
| Beijing Rehabilitation Hospital | OTHER |
| Hunan Provincial Rehabilitation Hospital | UNKNOWN |
| Beijing Tiantan Hospital | OTHER |
| Beijing Fengtai Rehabilitation Hospital |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Speaking Valve Group | Experimental | Passy-Muir Speaking Valve |
|
| Capping Group | Active Comparator | Tracheostomy tube capping |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Passy-Muir Speaking Valve | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Decannulation Success Rate | Proportion of participants with successful decannulation and no reintubation within 48 hours, based on total randomized participants. | 48 hours post-decannulation |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Decannulation | Number of days from randomization to successful decannulation. | From randomization to decannulation, assessed up to 30 days |
| Pneumonia Incidence at 30 Days | Proportion of decannulated participants diagnosed with pneumonia within 30 days |
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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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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qian Feng | Contact | 17207122873 | fengqian0263@163.com | |
| Hongying Jiang | Contact | 56981555 | 6jhy@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Hongying Jiang | Capital Medical University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Rehabilitation Hospital, Capital Medical University | Recruiting | Beijing | Beijing Municipality | 100043 | China |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D000098522 | Tracheostomy Decannulation |
| ID | Term |
|---|---|
| D014139 | Tracheostomy |
| D058109 | Airway Management |
| D013812 | Therapeutics |
| D020878 | Device Removal |
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| UNKNOWN |
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.
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| Tracheostomy tube capping | Other | 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. |
|
| 30 days post-decannulation |
| Reintubation Rate at 90 Days | Proportion of participants requiring reintubation within 90 days | 90 days post-decannulation |
| Mortality Rate at 90 Days | All-cause mortality within 90 days | 90 days post-decannulation |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D013514 |
| Surgical Procedures, Operative |
| D010030 | Ostomy |
| D013517 | Otorhinolaryngologic Surgical Procedures |
| D019616 | Thoracic Surgical Procedures |