Speaking Valve Trial vs. Capping Trial for Tracheostomy Decannulation in Prolonged Disorders of Consciousness

Not Applicable

Not yet recruiting

• Conditions: Prolonged Disorders of Consciousness

• Registration Number: NCT07173634
• Lead Sponsor: Hongying Jiang

Brief Summary

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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Study Timeline

• Status Verified: 2025-09
• Study First Submitted: 2025-09-04
• Study First Submitted QC: 2025-09-11
• Last Update Submitted: 2025-09-11
• Study First Posted: 2025-09-15
• Last Update Posted: 2025-09-15
• Study Start: 2025-10-01
• Primary Completion: 2026-10-01
• Study Completion: 2027-02-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 280

Inclusion Criteria

1. Adults (18-80 years) with tracheostomy
2. Prolonged DoC (>28 days) confirmed by CRS-R score >0
3. Ventilator-free >48h
4. PaCO₂ <60 mmHg
5. PCF ≥100 L/min
6. No sepsis/organ failure
7. Controlled pulmonary infection
8. Written informed consent by legal representative

Exclusion Criteria

1. Intolerance to cuff deflation:
2. SpO₂ <93% on O₂ supplementation OR Respiratory rate >20/min for >5min
3. Severe tracheal stenosis (>50% lumen occlusion on CT)
4. Death within 2 weeks post-enrollment
5. Participation in conflicting interventional trial

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Decannulation rate	At decannulation	Proportion passing full protocol
Decannulation success rate	At 48 h post decannulation	(Decannulation - Decannulation failure ) / Decannulation

Secondary Outcome Measures

Name	Time	Method
Time to decannulation	1year	Days from randomization to successful tube removal
Hospital stay duration	Up to 6 months	Days from randomization to discharge without tracheostomy care
CRS-R change rate	3 months	(Post-decannulation score - Baseline)/Baseline
Airway safety score1	48h post-decannulation	Pulse oxygen saturation (SpO₂) fluctuation, minimum value0%, maximum value 100%, the larger the value, the better the result
Airway safety score 2	48h post-decannulation	Blood carbon dioxide partial pressure (pCO₂) , normal range 35-45mmHg. Within the normal range it is good, the greater the deviation from the normal range, the worse the result the larger the value, the better the result.