Comparison of Speaking Valve Trial and Capping Trial in the Decannulation Process for Stroke Patients: A Randomized, Controlled, Multicenter Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Decannulation Success Rate
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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).
研究组 & 干预措施
Capping Group
Tracheostomy tube capping
干预措施: Tracheostomy tube capping (Other)
Speaking Valve Group
Passy-Muir Speaking Valve
干预措施: Passy-Muir Speaking Valve (Other)
结局指标
主要结局
Decannulation Success Rate
时间窗: 48 hours post-decannulation
Proportion of participants with successful decannulation and no reintubation within 48 hours, based on total randomized participants.
次要结局
- Time to Decannulation(From randomization to decannulation, assessed up to 30 days)
- Pneumonia Incidence at 30 Days(30 days post-decannulation)
- Reintubation Rate at 90 Days(90 days post-decannulation)
- Mortality Rate at 90 Days(90 days post-decannulation)
研究者
Hongying Jiang, MD
Principal Investigator
Capital Medical University