NCT07191509 Effects of Tracheostomy Decannulation on Respiratory Function
| NCT ID | NCT07191509 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Capital Medical University |
| Condition | Tracheostomy Decannulation |
| Study Type | OBSERVATIONAL |
| Enrollment | 100 participants |
| Start Date | 2025-10-01 |
| Primary Completion | 2026-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 100 participants in total. It began in 2025-10-01 with a primary completion date of 2026-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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 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.
Contact & Investigator
Hongying Jiang
STUDY CHAIR
Beijing Rehabilitation Hospital of Capital Medical University
Frequently Asked Questions
Who can join the NCT07191509 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Tracheostomy Decannulation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07191509 currently recruiting?
Yes, NCT07191509 is actively recruiting participants. Contact the research team at djlm1028@126.com for enrollment information.
Where is the NCT07191509 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT07191509 clinical trial?
NCT07191509 is sponsored by Capital Medical University. The principal investigator is Hongying Jiang at Beijing Rehabilitation Hospital of Capital Medical University. The trial plans to enroll 100 participants.