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ENROLLING BY INVITATION
NCT07183670

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

Sponsor: Hongying Jiang, MD

View on ClinicalTrials.gov

Summary

To evaluate the feasibility of a standardized tracheostomy decannulation protocol for patients with prolonged Disorders of Consciousness (pDoC) in rehabilitation hospitals.

Official title: Application of a Voice Valve-Based Decannulation Protocol in Tracheostomized Patients With a Prolonged Disorders of Consciousness: A Prospective Multicenter Cohort Study

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

OBSERVATIONAL

Enrollment

184

Start Date

2026-02-01

Completion Date

2027-05-01

Last Updated

2026-07-31

Healthy Volunteers

No

Interventions

DIAGNOSTIC_TEST

decannulation protocol

Step 1: The patient's clinical stability is confirmed. Step 2: Tolerance to the speaking valve is assessed. Step 3: The wearing time of the speaking valve is extended continuously for 4 h, and no tracheostomy cannula is used for sputum suction within 4 h. Step 4: Cough strength is evaluated to be good before decannulation. Decannulation Criteria: Pass Step 1 + Step 2 + Step 3 + Step 4

Locations (2)

Beijing Rehabilitation Hospital, Capital Medical University, Beijing,China

Beijing, Beijing Municipality, China

Beijing Rehabilitation Hospital, Capital Medical University

Beijing, China