NCT07191509

Effects of Tracheostomy Decannulation on Respiratory Function

Study on the Impact of Tracheostomy Decannulation on Pulmonary Function in Adult Patients

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: Capital Medical University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Tracheostomy Decannulation

Interventions

Type	Name	Description
DEVICE	Speaking Valve ，Tracheostomy Tube Occlusion ，Tracheostomy Tube Ventilation	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

Timeline

• Start date: 2025-10-01
• Primary completion: 2026-09-30
• Completion: 2026-12-31
• First posted: 2025-09-25
• Last updated: 2026-03-11

Locations

1 site across 1 country: China