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

Enrolling by invitation · Not applicable

Conditions studied: Prolonged Disorders of Consciousness

In brief

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.

Key facts

Study ID

NCT07173634

Run by

Hongying Jiang, MD

People needed

280

Starts

2026-02-01

Expected to finish

2027-05-01

Last updated by the study team

2026-05-22

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Beijing Rehabilitation Hospital, Capital Medical University, Beijing,China — Beijing, Beijing Municipality, China

Full record on ClinicalTrials.gov

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