By InvitationNot Applicable

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

China280 participantsStarted 2026-02-01

Plain-language 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.

Who can participate

Age range18 Years – 80 Years

SexALL

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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

What they're measuring

Decannulation rate

Timeframe: At decannulation

Decannulation success rate

Timeframe: At 48 h post decannulation

Trial details

NCT IDNCT07173634

SponsorHongying Jiang, MD

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-02-01

View on ClinicalTrials.gov More Prolonged Disorders of Consciousness trials