Effects of Tracheostomy Decannulation on Respiratory Function

Capital Medical University

Status: Not yet enrolling

Conditions: Tracheostomy Decannulation

Treatments: Device: Speaking Valve ，Tracheostomy Tube Occlusion ，Tracheostomy Tube Ventilation

Study type: Observational

Funder types: Other

Identifiers

NCT07191509

2025-HXKFZX-FGN-01

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.