Clinical Trial

A Voice Valve-Based Decannulation Protoco for Patients With a Prolonged Disorders of Consciousness

Study acronym: STEP-DoC
Enrolling by Invitation
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Summary
To evaluate the feasibility of a standardized tracheostomy decannulation protocol for patients with prolonged Disorders of Consciousness (pDoC) in rehabilitation hospitals.
Protocol Amendment History 3 changes
critical Primary endpoint(s) modified 2026-08-01
notable Enrollment increased: 144 -> 184 participants 2026-08-01
notable Enrollment reduced: 300 -> 144 participants 2026-06-24
Trial Details
NCT Number NCT07183670
Lead Sponsor Hongying Jiang, MD
Collaborators: Beijing Rehabilitation Hospital of Capital Medical University, Beijing Tiantan Hospital, Fengtai Rehabilitation Hospital of Beijing Municipality, People's Hospital of Zhengzhou University, Hunan Provincial Rehabilitation Hospital, Anhui Wanbei Rehabilitation Hospital, Jiangbin Hospital of Guangxi Zhuang Autonomous Region, The Second People's Hospital of Beihai
Conditions Prolonged Disorders of Consciousness, Tracheostomy
Enrollment 184 participants
Start Date 2026-02-01
Primary Completion 2027-02-01 (estimated)
Study Completion 2027-05-01 (estimated)
Updated on ClinicalTrials.gov 2026-07-31