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

NCT07173634 · tracked via the Priya Life Science China tracker

Sponsor

Hongying Jiang, MD

Phase

Not applicable

Started

2026-02-01

Last updated

2026-05-22

Condition(s) studied

Prolonged Disorders of Consciousness

Investigational drug(s) / intervention(s)

Speaking Valve TrialCapping Trial

Speaking Valve Trial: 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.

Capping Trial: 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.

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

80 Years

Healthy volunteers

Inclusion Criteria: 1. Adults (18-80 years) with tracheostomy 2. Prolonged DoC (\>28 days) confirmed by CRS-R score \>0 3. Ventilator-free \>48h 4. PaCO₂ \<60 mmHg 5. PCF ≥100 L/min 6. No sepsis/organ failure 7. Controlled pulmonary infection 8. Written informed consent by legal representative Exclusion Criteria: 1. Intolerance to cuff deflation: 2. SpO₂ \<93% on O₂ supplementation OR Respiratory rate \>20/min for \>5min 3. Severe tracheal stenosis (\>50% lumen occlusion on CT) 4. Death within 2 weeks post-enrollment 5. Participation in conflicting interventional trial

Primary outcome measure(s)

Decannulation rate — At decannulation
Proportion passing full protocol
Decannulation success rate — At 48 h post decannulation
(Decannulation - Decannulation failure ) / Decannulation

Trial sites (1)

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

More Hongying Jiang, MD trials in China

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

Multidimensional Dysfunction in Patients With Post-Intensive Care Syndrome in China Recruiting

Integrated Rehabilitation in HDU for Post-Intensive Care SyndromeLiberation in Patients With PICS Starting soon

Cough Flow as a Criterion Decannulation Threshold in Prolonged Tracheostomy Patients Starting soon

Comparison of Speaking Valve Trial and Capping Trial for Tracheostomy Decannulation in Stroke Patients Recruiting

Other trials for the same condition

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

Stellate Ganglion Block on Postoperative Sleep Status in Patients With Prolonged Disorders of Consciousness Starting soon

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 NCT07173634 on ClinicalTrials.gov ↗ ← All trials in China