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

NCT07183670 · tracked via the Priya Life Science China tracker

Sponsor

Hongying Jiang, MD

Phase

Observational

Started

2026-02-01

Last updated

2026-07-31

Condition(s) studied

Prolonged Disorders of ConsciousnessTracheostomy

Investigational drug(s) / intervention(s)

decannulation protocol

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

Study summary

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

Eligibility

Sex

ALL

Min age

18 Years

Max age

80 Years

Healthy volunteers

Inclusion Criteria: 1. Tracheostomy status 2. The duration of consciousness disorders\> 28 days 3. CRS-R score \>0 and \<17 4. Signed informed consent by legal representative Exclusion Criteria: 1. Non-PDOC tracheostomy patients 2. Death within 2 weeks post-referral

Primary outcome measure(s)

Decannulation success rate — At 48 hours post decannulation
(Decannulation - Decannulation failure ) / Total number of enrolled patients

Trial sites (2)

Facility	City	Region	Status
Beijing Rehabilitation Hospital, Capital Medical University, Beijing,China	Beijing	Beijing Municipality
Beijing Rehabilitation Hospital, Capital Medical University	Beijing	China

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Other trials for the same condition

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

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07183670 on ClinicalTrials.gov ↗ ← All trials in China