Clinical Trial

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

Study acronym: SPEAK-CAP
Enrolling by Invitation
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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.
Protocol Amendment History 4 amendments
This ClinicalTrials.gov record has been amended 4 times since 2025-09-11; most recent amendment 2026-05-19.
Status change: Not Yet Recruiting → Enrolling by Invitation 2026-02-11
Trial Details
NCT Number NCT07173634
Lead Sponsor Hongying Jiang, MD
Collaborators: Beijing Rehabilitation Hospital of Capital Medical University, Beijing Tiantan Hospital, Hunan Provincial Rehabilitation Hospital, Beijing Fengtai Rehabilitation Hospital
Conditions Prolonged Disorders of Consciousness
Enrollment 280 participants
Start Date 2026-02-01
Primary Completion 2027-02-01 (estimated)
Study Completion 2027-05-01 (estimated)
Updated on ClinicalTrials.gov 2026-05-22