Long-term Oxygen Treatment (LTOT) in Chronic Obstructive Pulmonary Disease: Factors Influencing Survival: Survival Factors in COPD Treated by Long-term Oxygen Therapy
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 750
- 试验地点
- 1
- 主要终点
- Survival in function of initial hypoxemia, body mass index and cardiovascular events
研究概览
简要总结
The purpose of this prospective cohort study is to determine factors involved in survival in new COPD patients treated by long-term oxygen therapy.
Background: long-term oxygen therapy is indicated in patients with severe COPD. No studies have been performed in the past 20-25 years to examine the results of early clinical trials. Further studies are necessary to understand the utility of oxygen therapy in severe COPD.
详细描述
long-term oxygen therapy prolongs life in patients with severe COPD and severe resting hypoxemia. The objective of this study is to measure the survival in relation to the level of initial resting hypoxemia, serious co-morbidities, and nutritional status in COPD patients treated by long-term oxygen therapy. After enrollment at the beginning of oxygen therapy, following data will be collected during 3 years. Lung function, blood gas analysis, exercise capacity measured by the 6-Min Walk Distance test (6-MWD), dyspnea scale, BODE index, quality of life, indirect and direct costs will be analyzed every year.
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
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •COPD patients on necessity of long-term oxygen therapy
- •Patients treated by LTOT, with or without clinically fulfilled criteria for LTOT, with PaO2<55mmHg or less at rest or during sleeping or less during exercise, if supplemental oxygen is demonstrated to improve the exercise-associated hypoxia. Patients with PaO2 56-59mmHg if they also have dependent edema, pulmonary hypertension or hematocrit higher than 56%
- •Patient clinically stable
- •Patient with oxygen device of ANTADIR network
- •Oral and written consent
排除标准
- •Patient with obstructive sleep apnea or overlap syndrome
- •Patient with non invasive ventilation
- •Patient with evolutive cancer.
- •Inability to complete questionnaires
- •Inability to attend outpatient clinic
结局指标
主要结局
Survival in function of initial hypoxemia, body mass index and cardiovascular events
时间窗: 3 years
次要结局
- Long-term oxygen therapy observance and duration(3 years)