Comparison of Speaking Valve Trial Versus Capping Trial in the Decannulation Process for Patients With Prolonged Disorders of Consciousness: A Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 280
- 试验地点
- 1
- 主要终点
- Decannulation rate
研究概览
简要总结
To assess whether the speaking valve trial, when employed as an indicator for extubation during the removal of tracheostomy tubes in patients with chronic consciousness disorder, provides superior benefits and heightened sensitivity relative to the conventional capping trial, thereby enhancing the overall extubation process.
详细描述
Patients with chronic consciousness disorder who require long-term mechanical ventilation and airway protection commonly undergo tracheostomy. However, tracheostomy tubes can cause inflammation, stenosis, excessive coughing, and swallowing dysfunction. Removing the tracheostomy tube, or extubation, can prevent long-term complications such as tracheal stenosis, tracheomalacia, vocal cord injury, and accidental extubation. Additionally, it enhances patient comfort, appearance, swallowing function, communication ability, and social integration. Therefore, for clinically stable patients with chronic consciousness disorder who can breathe spontaneously, have effective cough reflexes, and are capable of protecting their airways, early tube removal is advisable.In current extubation protocols, the capping trial is predominantly used to assess whether patients can tolerate tracheostomy tube removal. There have also been reports of studies using speaking valves as an alternative to the capping trial, but no direct comparison has been made between the two methods. Patients who can tolerate capping for 24 hours are generally considered suitable for tracheostomy tube removal. A speaking valve is a one-way valve placed at the end of the tracheostomy tube that directs airflow to the upper airway when the cuff is deflated. Studies have found that patients undergoing speaking valve training benefit in terms of vital signs, airway secretions, sense of smell, weaning from mechanical ventilation, post-tracheostomy extubation, hospital stay duration, and quality of life. However, it remains unclear whether this method can improve the success rate of extubation assessment in patients with chronic consciousness disorder. This study compares speaking valve training and the traditional capping trial in post-tracheostomy patients with chronic consciousness disorder, evaluating differences in extubation tolerance, extubation success rate, time to extubation, hospital stay duration, and improvement in consciousness levels.
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研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Adults (18-80 years) with tracheostomy
- •Prolonged DoC (>28 days) confirmed by CRS-R score >0
- •Ventilator-free >48h
- •PaCO₂ <60 mmHg
- •PCF ≥100 L/min
- •No sepsis/organ failure
- •Controlled pulmonary infection
- •Written informed consent by legal representative
排除标准
- •Intolerance to cuff deflation:
- •SpO₂ <93% on O₂ supplementation OR Respiratory rate >20/min for >5min
- •Severe tracheal stenosis (>50% lumen occlusion on CT)
- •Death within 2 weeks post-enrollment
- •Participation in conflicting interventional trial
研究组 & 干预措施
Speaking Valve (SV) Group
Stepwise speaking valve tolerance: 0.5h → 1h → 2h → 4h. Decannulation if: Tolerates a 4-hour speaking valve trial with pulse oxygen saturation (SpO₂) ≥ 95%, breathing rate (RR) < 20/min, and no signs of distress during the 4-hour trial.
干预措施: Speaking Valve Trial (Other)
Capping Group
Gradual capping: 1 hour → 4 hours → 6 hours → 12 hours → 24 hours → 48 hours. Decannulation if: Tolerates 48 hours of capping with SpO₂ ≥95%, respiratory rate (RR) <20/min, and no distress during the 48-hour trial.
干预措施: Capping Trial (Other)
结局指标
主要结局
Decannulation rate
时间窗: At decannulation
Proportion passing full protocol
Decannulation success rate
时间窗: At 48 h post decannulation
(Decannulation - Decannulation failure ) / Decannulation
次要结局
- Time to decannulation(1year)
- Hospital stay duration(Up to 6 months)
- CRS-R change rate(3 months)
- Airway safety score1(48h post-decannulation)
- Airway safety score 2(48h post-decannulation)
研究者
Hongying Jiang, MD
Principal Investigator
Capital Medical University
