Speaking Valve Trial vs. Capping Trial for Tracheostomy Decannulation in Prolonged Disorders of Consciousness
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Speaking Valve Trial, Capping Trial.
- Who it may be relevant to
- Registry conditions: Prolonged Disorders of Consciousness. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Comparison of Speaking Valve Trial Versus Capping Trial in the Decannulation Process for Patients With Prolonged Disorders of Consciousness: A Randomized Controlled Study
Overview
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.
Detailed description
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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Interventions
- Other Speaking Valve Trial
The speaking valve group ascertains a patient's eligibility for decannulation following the results of the speaking valve test. A patient who can endure a 4-hour trial with a speaking valve, maintaining a pulse oxygen saturation (SpO₂) of at least 95%, a breathing rate (RR) below 20 per minute, and exhibiting no signs of distress throughout the trial, qualifies for decannulation. - Other Capping Trial
The capping valve group determines a patient's eligibility for decannulation based on the results of the capping test. A patient who can tolerate 48 hours of capping with a pulse oxygen saturation (SpO₂) of ≥95%, a breathing rate (RR) of \<20/min, and no signs of distress during the 48-hour trial, is eligible for decannulation.
Primary outcome measures
- Decannulation rate [Time frame: At decannulation]
- Decannulation success rate [Time frame: At 48 h post decannulation]
Secondary outcome measures (5)
- Time to decannulation [Time frame: 1year]
- Hospital stay duration [Time frame: Up to 6 months]
- CRS-R change rate [Time frame: 3 months]
- Airway safety score1 [Time frame: 48h post-decannulation]
- Airway safety score 2 [Time frame: 48h post-decannulation]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- Beijing Rehabilitation Hospital, Capital Medical University, Beijing,China — Beijing
Identifiers
NCT: NCT07173634 · 2025-hxkf-s&tc