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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline (Day -1) and Day +5 after decannulation. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Forced Expiratory Volume in 1 Second (FEV1) [L] | Same measurement procedure as for FVC; endpoint is mean change in liters from Day -1 (capped) to Day +5 (oral). | Baseline (Day -1) and Day +5 after decannulation. |
| Change in FEV1/FVC Ratio [%] |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jia Deng | Contact | +8656981423 | djlm1028@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Hongying Jiang | Beijing Rehabilitation Hospital of Capital Medical University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Rehabilitation Hospital, Capital Medical University | Recruiting | Beijing | China |
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Calculated from simultaneously measured FEV1 and FVC (FEV1 ÷ FVC × 100). Endpoint is mean percent change between Day -1 and Day +5. |
| Baseline (Day -1) and Day +5 after decannulation. |
| Change in Tidal Volume (VT) [mL] | Average VT of three consecutive quiet breaths recorded by spirometer under the same two time points; higher values denote better function. | Baseline (Day -1) and Day +5 after decannulation. |
| Change in Minute Ventilation (VE) [L/min] | VE calculated automatically by the spirometer (VT × breathing frequency). Endpoint is mean change from Day -1 to Day +5. | Baseline (Day -1) and Day +5 after decannulation. |
| Change in Maximum Voluntary Ventilation (MVV) [L/min] | Twelve-second MVV manoeuvre converted to one-minute value; mean change between Day -1 and Day +5. | Baseline (Day -1) and Day +5 after decannulation. |
| Change in Breathing Frequency (BF) [breaths/min] | Breaths per minute recorded by spirometer during quiet breathing; mean change from baseline to Day +5 (lower values indicate improvement). | Baseline (Day -1) and Day +5 after decannulation. |
| Change in Arterial Carbon Dioxide Partial Pressure (PaCO₂) [mm Hg] | Same blood-gas procedure; endpoint is mean change in PaCO₂. | Day -1 and Day +5. |
| Change in Arterial Oxygen Partial Pressure (PaO₂) [mm Hg] | Arterial blood gas sample taken immediately after pulmonary function test at each time point; endpoint is mean change in PaO₂ (mm Hg). | Day -1 and Day +5. |
| Change in Blood pH [unitless] | Arterial blood pH measured together with gases; endpoint is mean change (Day -1 to Day +5). | Day -1 and Day +5. |
| Change in Base Excess (BE) [mmol/L] | Base Excess from arterial blood gas analysis; endpoint is mean change between the two time points. | Day -1 and Day +5. |