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临床试验/NCT07173634
NCT07173634Enrolling By Invitation不适用

Comparison of Speaking Valve Trial Versus Capping Trial in the Decannulation Process for Patients With Prolonged Disorders of Consciousness: A Randomized Controlled Study

Hongying Jiang, MD1 个研究点 分布在 1 个国家目标入组 280 人开始时间: 2026年2月1日最近更新:
干预措施

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

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

Experimental

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

Active Comparator

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

发起方
Hongying Jiang, MD
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Hongying Jiang, MD

Principal Investigator

Capital Medical University

研究点 (1)

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