Effects of Tracheostomy Decannulation on Respiratory Function
Study on the Impact of Tracheostomy Decannulation on Pulmonary Function in Adult Patients
Capital Medical University
100 participants
Oct 1, 2025
OBSERVATIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria5
- 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 Criteria6
- 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.
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
Speaking Valve: Participants are assessed while breathing through a one-way speaking valve attached to the tracheostomy tube. The valve directs exhaled air through the upper airway, restoring phonation and more closely simulating post-decannulation airflow. The assessment is performed for up to 4 hours to evaluate tolerance and respiratory function prior to tracheostomy tube removal. Tracheostomy Tube Occlusion: Participants undergo a capping trial, in which the tracheostomy tube is completely occluded. During this intervention, patients must breathe entirely through their natural upper airway, which increases airway resistance and tests their ability to tolerate decannulation. The capping trial is conducted for 24-48 hours, with monitoring for signs of intolerance. Tracheostomy Tube Ventilation: This intervention involves assessment of respiratory function while the participant breathes directly through the open tracheostomy tube, representing the baseline state prior to any decannu
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07191509