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

NCT07173634 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 280

Last updated 2026-05-22

No results posted yet for this 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.

Conditions

  • Prolonged Disorders of Consciousness

Interventions

OTHER

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.

OTHER

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.

Sponsors & Collaborators

  • Beijing Rehabilitation Hospital

    collaborator OTHER

  • Beijing Tiantan Hospital

    collaborator OTHER

  • Hunan Provincial Rehabilitation Hospital

    collaborator UNKNOWN

  • Beijing Fengtai Rehabilitation Hospital

    collaborator UNKNOWN

  • Hongying Jiang, MD

    lead OTHER

Principal Investigators

  • Hongying Jiang · Beijing Rehabilitation Hospital, Capital Medical University, Beijing

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-01
Primary Completion
2027-02-01
Completion
2027-05-01

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07173634 on ClinicalTrials.gov