Target Volume With a Pressure Controlled Ventilator in Obesity Hypoventilation Syndrome With Persistent Oxygen Desaturations With Continuous Positive Airway Pressure
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 3
- 主要终点
- Evolution of daytime PaCO2 of NIV without target volume, with Target volume and with CPAP alone
研究概览
简要总结
The purpose of this study is to investigate the evolution of daytime partial pressure of carbon dioxide in the blood (PaCO2) after 6 weeks of noninvasive ventilation-pressure support ventilation (NIV-PSV) with target volume versus continuous positive airway pressure (CPAP) alone versus NIV-PSV.
详细描述
Compare the efficacy between 3 ventilation modes (CPAP, PSV and PSV with Target Volume) on patients with obesity hypoventilation syndrome already treated with CPAP but with persistent desaturations.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients from 20 to 75 years old.
- •Body mass index > 32 kg/m2
- •Nocturnal oxygen desaturation 5 mn ≤ 88% under CPAP,
- •PaCO2 > 5,9 kPa in diurnal, spontaneous ventilation
排除标准
- •Patients with COPD and VEMS/FVC < 65%
- •Patients with CHF and periodic breathing (Ejection Fraction <40%)
- •Patients with a recent respiratory decompensation in the month preceding inclusion
研究组 & 干预措施
NIV-PSV without Target Volume
Pressure Support Non Invasive Ventilation without Target Volume
干预措施: Breas Vivo 40 (Device)
NIV-PSV with Target Volume
Non Invasive Pressure Support Ventilation with Target Volume set
干预措施: Breas Vivo 40 (Device)
NIV-CPAP
Pressure Support Ventilation in CPAP mode
干预措施: Breas Vivo 40 (Device)
结局指标
主要结局
Evolution of daytime PaCO2 of NIV without target volume, with Target volume and with CPAP alone
时间窗: 6 weeks
次要结局
- Evolution of subjective and objective sleepness (Osler)(6 weeks)
- Evolution of quality of ventilation (Leaks, asynchronism, others events)(6 weeks)
- Evolution of blood inflammation (IL6, TNFα et CRP)(6 weeks)
- Evolution in dyspnea scores (BDI/TDI and Simon Score)(6 weeks)
- Compliance (hours of treatment)(6 weeks)
- Cardiovascular parameters on Arterial strength (pulse velocity) and Endothelial function (Post ischemic test)(6 weeks)
- Evolution of insulin résistance(6 weeks)
- Sleep quality (PSG) between the 3 groups at 6 weeks(6 weeks)