Effects of Tracheostomy Decannulation on Respiratory Function

ConditionTracheostomy Decannulation

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18+

SponsorCapital Medical University

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial population

Adult (≥18 years) in-patients with a pre-existing tracheostomy who are receiving multidisciplinary rehabilitation care at the Respiratory Rehabilitation Center of Beijing Rehabilitation Hospital, Capital Medical University. All candidates have a stable primary illness, are clinically judged ready for elective decannulation, can tolerate a one-way speaking valve for at least 4 hours, and are able to cooperate with bedside spirometry tests. Both sexes and all underlying diagnoses that required tracheostomy (e.g., neurologic, traumatic, postsurgical or pulmonary conditions) are eligible provided they meet the inclusion/exclusion criteria.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Speaking Valve ，Tracheostomy Tube Occlusion ，Tracheostomy Tube Ventilation
Device
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

Treatment groups

No treatment groups listed

Trial 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.

Time frame