Effects of Tracheostomy Decannulation on Respiratory Function
Recruiting now
Conditions studied: Tracheostomy Decannulation
In brief
This single-center prospective study enrolls adult patients with long-term tracheostomy who are ready for tube removal (decannulation). Twenty-four hours before decannulation, each participant will receive three physiologic tests-breathing through the tracheostomy tube, breathing with a one-way speaking valve, and breathing with the tube capped. Standard pulmonary-function and arterial-blood-gas measurements will be taken during each test and again 5 days after the tube is removed. The study compares these methods to identify which pre-decannulation test best predicts safe, successful decannulation and to describe the overall impact of tube removal on respiratory function.
Key facts
- Study ID
- NCT07191509
- Run by
- Capital Medical University
- People needed
- 100
- Starts
- 2025-10-01
- Expected to finish
- 2026-12-31
- Last updated by the study team
- 2026-03-11
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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 is running
- Beijing Rehabilitation Hospital, Capital Medical University — Beijing, China (enrolling)
Full record on ClinicalTrials.gov
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