Study on the Impact of Tracheostomy Decannulation on Pulmonary Function in Adult Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Change in Forced Vital Capacity (FVC) [L]
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Change in Forced Vital Capacity (FVC) [L]
时间窗: Baseline (Day -1) and Day +5 after decannulation.
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.
次要结局
- Change in Minute Ventilation (VE) [L/min](Baseline (Day -1) and Day +5 after decannulation.)
- Change in Maximum Voluntary Ventilation (MVV) [L/min](Baseline (Day -1) and Day +5 after decannulation.)
- Change in FEV1/FVC Ratio [%](Baseline (Day -1) and Day +5 after decannulation.)
- Change in Blood pH [unitless](Day -1 and Day +5.)
- Change in Base Excess (BE) [mmol/L](Day -1 and Day +5.)
- Change in Forced Expiratory Volume in 1 Second (FEV1) [L](Baseline (Day -1) and Day +5 after decannulation.)
- Change in Tidal Volume (VT) [mL](Baseline (Day -1) and Day +5 after decannulation.)
- Change in Arterial Oxygen Partial Pressure (PaO₂) [mm Hg](Day -1 and Day +5.)
- Change in Arterial Carbon Dioxide Partial Pressure (PaCO₂) [mm Hg](Day -1 and Day +5.)
- Change in Breathing Frequency (BF) [breaths/min](Baseline (Day -1) and Day +5 after decannulation.)
研究者
Jingyi Ge
Sponsor-Investigator
Capital Medical University