Stroke
Conditions
Brief 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.
Detailed description
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.
Interventions
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.
OTHERTracheostomy 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.
Sponsors
Hongying Jiang, MD
Beijing Rehabilitation Hospital
Hunan Provincial Rehabilitation Hospital
Beijing Tiantan Hospital
Beijing Fengtai Rehabilitation Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Decannulation Success Rate | 48 hours post-decannulation | Proportion of participants with successful decannulation and no reintubation within 48 hours, based on total randomized participants. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Decannulation | From randomization to decannulation, assessed up to 30 days | Number of days from randomization to successful decannulation. |
| Pneumonia Incidence at 30 Days | 30 days post-decannulation | Proportion of decannulated participants diagnosed with pneumonia within 30 days |
| Reintubation Rate at 90 Days | 90 days post-decannulation | Proportion of participants requiring reintubation within 90 days |
| Mortality Rate at 90 Days | 90 days post-decannulation | All-cause mortality within 90 days |
Countries
China
Contacts
CONTACTQian Feng
CONTACTHongying Jiang
STUDY_CHAIRHongying Jiang
Capital Medical University
Outcome results
None listed