NCT02499718Unknown不适用
Non-invasive Positive Pressure Ventilation for the Treatment of Severe Stable Chronic Obstructive Pulmonary Disease
Guangzhou Institute of Respiratory Disease1 个研究点 分布在 1 个国家目标入组 368 人开始时间: 2014年1月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 368
- 试验地点
- 1
- 主要终点
- Severe Respiratory Insufficiency (SRI) Questionnaire
研究概览
简要总结
Assessment of the effect and safety of noninvasive positive pressure ventilation for severe stable chronic obstructive pulmonary disease
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •clinically stable, hypercapnic GOLD stage IV COPD, aged 18 years or older, baseline arterial carbon dioxide pressure (PaCO2) of 6.7 kPa (50 mmHg) or higher and a pH higher than 7·35, measured after at least 1 h rest in a sitting position.
排除标准
- •thorax or the lung other than COPD
- •No smoking or Cigarette≤10/day
- •obesity with a bodymass index (BMI) ≥40 kg/m²
- •malignant co-morbidities,severe heart failure (New York Heart Association stage IV),unstable angina, and severe arrhythmias.
结局指标
主要结局
Severe Respiratory Insufficiency (SRI) Questionnaire
时间窗: 1 year
次要结局
- Baseline Dyspnea Index/Transition Dyspnea Index(1 year)
- Chromic Respiratory Questionnaire(1 year)
- The frequency of readmission(1 year)
- Pulmanory function(1 year)
- 6 Minute-Walking Distance and Borg Score(1 year)
- Chronic Obstructive Pulmonary Disease (COPD) Assessment Test(1 year)
- Blood gas analysis(1 year)
- The frequency of exacerbation(1 year)
- The frequency of ICU readmission(1 year)
- survival rate(1 year)
研究者
LuQian Zhou
Assistant Professor of Guangzhou Institute of Respiratory Disease
Guangzhou Institute of Respiratory Disease
研究点 (1)
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