Status:
NOT_YET_RECRUITING
Speaking Valve Trial vs. Capping Trial for Tracheostomy Decannulation in Prolonged Disorders of Consciousness
Lead Sponsor:
Hongying Jiang
Collaborating Sponsors:
Beijing Rehabilitation Hospital
Beijing Tiantan Hospital
Conditions:
Prolonged Disorders of Consciousness
Eligibility:
All Genders
18-80 years
Phase:
NA
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 ben...
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, steno...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2027
Estimated Enrollment :
280 Patients enrolled
Trial Details
Trial ID
NCT07173634
Start Date
October 1 2025
End Date
February 1 2027
Last Update
September 23 2025
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