NCT02021448终止不适用
Predictive Factors of Obesity-hypoventilation Syndrome (OHS) Among Obese Subjects- ETUDE COHYPOB -
University Hospital, Strasbourg, France12 个研究点 分布在 1 个国家目标入组 188 人开始时间: 2013年12月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 188
- 试验地点
- 12
- 主要终点
- Occurrence of obesity-hypoventilation syndrome
研究概览
简要总结
Investigate whether the course of an isolated nocturnal alveolar hypoventilation can predict the future occurrence of obesity-hypoventilation syndrome (OHS) in obese subjects
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Obese volunteer Subject (BMI> 30 kg/m2)
- •Adults of either sex
- •Social security affiliation
- •Written informed consent
排除标准
- •Confirmed OHS at baseline defined by a daytime hypercapnia with PaCO2> 45mmHg
- •Any cause of chronic respiratory failure other than obesity such as COPD, chest deformation, phrenic nerve paralysis, pulmonary fibrosis, neuromuscular disease, a history of mutilating thoracic surgery ...
- •Obstructive ventilatory defect with FEV1/ FVC <70% post-bronchodilator
- •Long term oxygen therapy, noninvasive ventilation, continuous positive airway pressure
- •Any serious illness involving life-threatening within 3 years after inclusion
- •Drug or alcohol abuse
- •Pregnancy
结局指标
主要结局
Occurrence of obesity-hypoventilation syndrome
时间窗: 3 years
partial pressure of carbon dioxide in the arterial blood \> 45mmHg
次要结局
未报告次要终点
研究者
研究点 (12)
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