Effects of Tracheostomy Decannulation on Respiratory Function

N/ANot Yet RecruitingNCT07191509

Capital Medical University120 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

120

Conditions

Tracheostomy Decannulation

Interventions

Speaking Valve ，Tracheostomy Tube Occlusion ，Tracheostomy Tube VentilationDEVICE

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Change in Forced Vital Capacity (FVC) [L]

FVC is obtained with a calibrated portable spirometer. Three acceptable manoeuvres are performed and the highest value kept. Baseline is recorded on Day -1 while the tracheostomy tube is capped; the same test is repeated on Day +5 during oral breathing after successful decannulation. The endpoint is the mean change (Day +5 minus Day -1) in liters; higher values indicate better respiratory function.