Comparison of Two Noninvasive Positive Pressure Ventilation Devices Using Target Volume Modes in Obesity Hypoventilation Syndrome (OHS): A Pilot Randomized Crossover Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Mean Nocturnal transcutaneous CO2 pressure (Mean nocturnal PtCO2)
研究概览
简要总结
Patients with OHS are efficiently managed with long term home-based nocturnal noninvasive positive pressure ventilation (NIPPV). Several NIPPV devices offer the feature of automatically adjusting pressure support (and/or respiratory back-up rate) on the basis of a pre-determined "ideal tidal volume" or "ideal ventilation". However algorithms used to achieve these ideal targets are different among different commercialized devices and the relative efficacy from an algorithm compared to another remains unknown. The main objective is this study is to compare two commercialized NIPPV that have this option
详细描述
RESMED Stellar-150 (IVAPS mode)versus PHILIPS-RESPIRONICS A30 (AVAPS-mode).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient with Obesity hypoventilation Syndrome (BMI≥ 30 kg/m2 and diurnal PaCO2 ≥ 45mmHg at diagnosis after exclusion of others causes of hypoventilation)
- •18 to 75 years old
- •In stable state but treated by nocturnal NIPPV for more than 3 months and adherent to NIPPV (above 4h/night).
排除标准
- •patient treated with additional long term Oxygen therapy
- •Patient previously treated by AVAPS mode or IVAPS mode
研究组 & 干预措施
AVAPS
AVAPS mode(BIPAP-A30-PHILIPS-RESPIRONICS)1 night
干预措施: IVAPS (Device)
IVAPS
IVAPS mode(STELAR 150-RESMED)1 night
干预措施: AVAPS (Device)
结局指标
主要结局
Mean Nocturnal transcutaneous CO2 pressure (Mean nocturnal PtCO2)
时间窗: 1 night
transcutaneous CO2 pressure is measured overnight. It is a reliable estimation of arterial PaCO2 to monitor nocturnal ventilation in adults with chronic respiratory failure.
次要结局
- Mean transcutaneous CO2 pressure during REM Sleep(1 Night)
- Mean nocturnal SpO2(1 night)
- Micro-arousals/hour of sleep(1 night)
- Sleep Quality assess by Visual analogic scale (100mm)(1 night)
- Respiratory residual events detected by NIPPV built-in softwares(1 Night)
- Awake arterial PaCO2 after 1 hour of NIPPV withdrawal(After 1 night)