Early vs. Late Percutaneous Dilation Tracheostomy in Mechanically Ventilated Patients With Chronic Obstructive Pulmonary Disease
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 23
- 试验地点
- 2
- 主要终点
- Cumulative duration of mechanical ventilation (in days)
研究概览
简要总结
The purpose of this study is:
- to evaluate the optimal time-point for percutaneous dilation tracheostomy in COPD patients in terms of duration on mechanical ventilation, length of stay on ICU and mortality;
- to evaluate the rate of infections and infectious complications of tracheostomized COPD patients;
- to evaluate the spectrum of pathogens in tracheostomized and intubated COPD patients;
- to evaluate the amount of sedatives used in mechanically ventilated COPD patients;
- to assess the quality of life in COPD patients tracheostomized after 3 or after 10 days.
详细描述
Screening of patients following inclusion and exclusion criteria on all units of the Department of Critical Care will occur on a daily basis.
Randomization will be performed by blocks of sealed envelopes containing random numbers which are deposited at a central space within the Department of Critical Care Medicine. Randomization is performed as permuted block randomization.
Collection of baseline parameters (last/current lung function test, last/current 6-min walk test, cardiac stress test - if accessible) If not accessible, current lung function test results (at least FEV1 and FVC) are requested from the patient's general physician or pulmonologist to determine GOLD stage.
Patients randomized into the (early tracheostomy) study group, will undergo tracheostomy at the next possible opportunity but not later than 72 h after initiation of invasive ventilation. Patients of the control group will be invasively ventilated at least until Day 10.
Before tracheostomy a complete endoscopic inspection of the bronchial system will be performed routinely. Bronchoalveolar lavage fluid (BALF) will be obtained from sites of pulmonary infiltrations. In case of no radiographically or bronchoscopic detectable infiltrations BALF will be drawn from the Middle Lobe.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
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
- •Diagnosis of COPD (GOLD stage III or IV)
- •Suspected long-time invasive mechanical ventilation due to ARF (> 10 days)
- •Informed consent of the patient or legal guardian
排除标准
- •Severe neurological failure (such as stroke, cerebral haemorrhage etc.)
- •Immunosuppressant therapy (with the exception of steroid therapy)
- •Major risk of bleeding
- •Intubation > 72 h
- •Contraindication for dilation tracheotomy
- •Impossibility of intubation
结局指标
主要结局
Cumulative duration of mechanical ventilation (in days)
时间窗: Day 1 - 28
Cumulative duration of mechanical ventilation (in days)
次要结局
- All-cause mortality(Day 28, 90 and end of ICU stay)
- Cumulative use of sedatives(Day 1 - 28)
- Length of stay on ICU / hospital(end of ICU / hospital stay)
- Infections (Ventilator-associated pneumonia, spectrum of pathogens in BALF, infectious complications)(Day 1 - 28)
- Quality of Life - Questionnaire(discharge from ICU, day 28 and day 90)