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

NCT07173634 | Enrolling By Invitation DMC

• 1 other identifier: 2025-hxkf-s&tc
• Study Type: interventional
• Target: 280
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Prolonged Disorders of Consciousness

Keywords

Prolonged disorders of consciousness; Decannulation; Speaking wave; Capping; Rehabilitation

Outcome Measures

Primary Outcomes (2)

• Decannulation rate

  Proportion passing full protocol

  At decannulation

• Decannulation success rate

  (Decannulation - Decannulation failure ) / Decannulation

  At 48 h post decannulation

Secondary Outcomes (5)

• Time to decannulation

  1year

• Hospital stay duration

  Up to 6 months

• CRS-R change rate

  3 months

• Airway safety score1

  48h post-decannulation

• Airway safety score 2

  48h post-decannulation

Study Arms (2)

Speaking Valve (SV) Group

EXPERIMENTAL

Stepwise speaking valve tolerance: 0.5h → 1h → 2h → 4h. Decannulation if: Tolerates a 4-hour speaking valve trial with pulse oxygen saturation (SpO₂) ≥ 95%, breathing rate (RR) \< 20/min, and no signs of distress during the 4-hour trial.

Other: Speaking Valve Trial

Capping Group

ACTIVE COMPARATOR

Gradual capping: 1 hour → 4 hours → 6 hours → 12 hours → 24 hours → 48 hours. Decannulation if: Tolerates 48 hours of capping with SpO₂ ≥95%, respiratory rate (RR) \<20/min, and no distress during the 48-hour trial.

Other: Capping Trial

Interventions

Capping Trial OTHER

The capping valve group determines a patient's eligibility for decannulation based on the results of the capping test. A patient who can tolerate 48 hours of capping with a pulse oxygen saturation (SpO₂) of ≥95%, a breathing rate (RR) of \<20/min, and no signs of distress during the 48-hour trial, is eligible for decannulation.

Capping Group

Speaking Valve Trial OTHER

The speaking valve group ascertains a patient's eligibility for decannulation following the results of the speaking valve test. A patient who can endure a 4-hour trial with a speaking valve, maintaining a pulse oxygen saturation (SpO₂) of at least 95%, a breathing rate (RR) below 20 per minute, and exhibiting no signs of distress throughout the trial, qualifies for decannulation.

Speaking Valve (SV) Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Beijing Rehabilitation Hospital: collaborator
• Beijing Tiantan Hospital: collaborator
• Hongying Jiang, MD: lead

Study Sites (1)

Beijing Rehabilitation Hospital, Capital Medical University, Beijing,China

Beijing, Beijing Municipality, 100043, China

Location

Study Officials

• Hongying Jiang

  Beijing Rehabilitation Hospital, Capital Medical University, Beijing

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 4, 2025
• First Posted: September 15, 2025
• Study Start: February 1, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: February 13, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)