How removing a tracheostomy affects breathing

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Beijing Rehabilitation Hospital, Capital Medical University
  Beijing, China Recruiting

Study contacts

• Study coordinator: Jia Deng
• Email: djlm1028@126.com
• Phone: +8656981423

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.