Status:
NOT_YET_RECRUITING
Effects of Tracheostomy Decannulation on Respiratory Function
Lead Sponsor:
Capital Medical University
Conditions:
Tracheostomy Decannulation
Eligibility:
All Genders
18+ years
Brief 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 re...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT07191509
Start Date
October 1 2025
End Date
December 31 2026
Last Update
September 25 2025
Active Locations (1)
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1
Beijing Rehabilitation Hospital, Capital Medical University
Beijing, China