How removing a tracheostomy affects breathing

Study on the Impact of Tracheostomy Decannulation on Pulmonary Function in Adult Patients

This project will test three breathing checks—breathing through the tube, using a one-way speaking valve, and capping the tube—before and after removing a long-term tracheostomy in adults to see which best predicts safe removal.

Quick facts

• Study type: Observational
• Enrollment: 100 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Capital Medical University (other)
• Locations: 1 site (Beijing)
• Trial ID: NCT07191509 on ClinicalTrials.gov

What this trial studies

This single-center prospective observational study enrolls adults with long-term tracheostomies who are scheduled for elective decannulation at a rehabilitation hospital in Beijing. Twenty-four hours before decannulation participants undergo three physiologic tests—breathing through the tracheostomy tube, breathing with a one-way speaking valve, and breathing with the tube capped—while standard pulmonary function tests and arterial blood gases are recorded. The same pulmonary and arterial measurements are repeated five days after the tube is removed. The study compares pre-decannulation test results to post-decannulation outcomes to identify which pre-test best predicts safe, successful decannulation and to describe changes in respiratory function after removal.

Who should consider this trial

Good fit: Adults (≥18 years) with a stable primary illness who have a long-term tracheostomy, are scheduled for elective decannulation in the rehabilitation unit, can tolerate a one-way speaking valve for ≥4 hours, and can perform bedside spirometry and consent.

Not a fit: Patients who cannot perform lung-function testing, have unstable cardiopulmonary or neurologic conditions, require isolation precautions, or need immediate re-intubation/re-cannulation are unlikely to benefit.

Why it matters

Potential benefit: If successful, clinicians could use the best-performing bedside test to reduce failed decannulations and related complications, making tube removal safer and more predictable for patients.

How similar studies have performed: Prior work using speaking valves, capping trials, and tube occlusion to predict decannulation outcomes has shown mixed but generally promising results, so this approach builds on existing, partially validated methods.

Eligibility criteria

Inclusion Criteria:

* Age ≥ 18 years.
* Tracheostomised patient whose primary illness is stable and who is scheduled for elective decannulation in the rehabilitation unit.
* Able to tolerate a one-way speaking valve for ≥ 4 h on the day before planned decannulation.
* Capable of following instructions and completing bedside spirometry.
* Patient (or legally authorised representative) has provided written informed consent.

Exclusion Criteria:

* No tracheostomy in place or requirement for re-intubation/re-cannulation after planned decannulation.
* Inability to perform lung-function testing either via the tracheostomy tube or via the mouth/nose (e.g., severe upper-airway obstruction, facial deformity).
* Unstable cardiopulmonary or neurological status that makes spirometry unsafe (e.g., ongoing myocardial ischemia, uncontrolled arrhythmia, severe agitation).
* Any acute condition requiring isolation precautions that preclude study procedures.
* Refusal or inability to sign informed consent.
* Missing or incomplete key outcome data.

Where this trial is running

Beijing

• Beijing Rehabilitation Hospital, Capital Medical University — Beijing, China (RECRUITING)

Study contacts

• Study coordinator: Jia Deng

Conditions: Tracheostomy Decannulation, Speaking Valve, Pulmonary Function Test, Tracheostomy Tube Occlusion