Non Invasive Ventilation and Nocturnal Alveolar Hypoventilation in Patients With Chronic Obstructive Pulmonary Disease (COPD) Treated by Long Term Oxygen Therapy at Home
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- Nocturnal transcutaneous pressure CO2 (PtCO2)
研究概览
简要总结
The aim of this study is to investigate the efficacy of non-invasive ventilation (NIV) on nocturnal hypoventilation in patients with chronic obstructive pulmonary disease (COPD) who are on long term oxygen therapy (LTOT) at home.
详细描述
This is a prospective, randomized, open labelled study. The primary outcome is nocturnal transcutaneous CO2 (PtCO2) after 3 months of non-invasive ventilation. Three hundred COPD patients on LTOT will be screened and assessed by pulmonary function tests, blood gases and nocturnal PtCO2 at their home. This will allow the determination of the prevalence of nocturnal hypoventilation in COPD patients on LTOT (a secondary outcome) and to select patients who meet the inclusion criteria for the RCT and randomization to NIV + LTOT or to continue LTOT alone (n=38). Patients will undergo the same assessments at the end of the three-month intervention period.
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
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •chronic obstructive pulmonary disease (COPD)
- •on long term oxygen therapy (LTOT)
- •affiliated to French social security system or equivalent
- •informed consent signed
排除标准
- •Diurnal PtCO2 >55mmHg
- •Patient who has had an exacerbation of COPD requiring a change in management or treatment in the last 4 weeks prior to the inclusion visit.
- •Pregnant or breathfeeding women
- •Prisonners or persons who require protection by the law
- •Exclusion period from another study
- •Persons who, according to the investigator, are expected no to meet all study obligations
结局指标
主要结局
Nocturnal transcutaneous pressure CO2 (PtCO2)
时间窗: 3 months
Measurement of nocturnal PtCO2 using the SenTec system
次要结局
- Triglycerides(3 months)
- HBA1c(3 months)
- Fatigue score(3 months)
- Saint George's Respiratory Questionnaire(3 months)
- PaO2(3 months)
- SaO2(3 months)
- Dyspnea score(3 months)
- Fasting Glucose(3 months)
- CRPus(3 months)
- Vital capacity(3 months)
- PaCO2(3 months)
- Energy expenditure(3 months)
- Heart Rate(3 months)
- FEV1(3 months)
- Time in supine and sitting positions(3 months)
- Steps per day(3 months)
- Cholesterol(3 months)