The Evaluation of the Astral VAPS AutoEPAP Treatment Algorithm
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- ResMed
- 入组人数
- 42
- 试验地点
- 10
- 主要终点
- Oxygen Desaturation Index 4% (ODI4%)
研究概览
简要总结
Patients with chronic respiratory failure such as those associated with Chronic Obstructive Pulmonary Disease (COPD), Obesity Hypoventilation Syndrome (OHS), Obstructive Sleep Apnea (OSA) or Neuromuscular Disease (NMD) are increasingly managed with domiciliary non-invasive positive pressure ventilation (NIPPV). The aim of this study is to now compare the Automatic Expiratory Positive Airway Pressure (AutoEPAP) algorithm with a fixed manual EPAP in iVAPS mode on an Astral mixed mode ventilator. It is proposed that the automatic settings of AutoEPAP will be as effective at managing respiratory failure and upper airway obstruction (UAO) as manual EPAP on the Astral device. Specifically demonstrating that the AutoEPAP function is as effective at treating UAO as manual EPAP.
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
- Single (Participant)
盲法说明
Patients were masked to the mode of treatment. The Core Lab was masked to the mode of treatment for all patients.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
iVAPS with manual EPAP
This is a crossover study. During overnight PSG, Astral device will be set using iVAPS with manual EPAP on the first night, and on iVAPS with AutoEPAP on the second night.
干预措施: Astral (Device)
iVAPS with AutoEPAP
This is a crossover study. During overnight PSG, Astral device will be set using iVAPS with AutoEPAP on the first night, and on iVAPS with manual EPAP on the second night.
干预措施: Astral (Device)
结局指标
主要结局
Oxygen Desaturation Index 4% (ODI4%)
时间窗: Overnight, up to 8 hrs on nights 1 and 2
Mean paired difference AutoEPAP-manual EPAP: Comparison of Oxygen Desaturation Index 4% (ODI4%) values between groups by using mean ODI4% (#events/hour). A cross-over analysis was generated to investigate the influence of a possible period effect on the primary endpoint, paired change in ODI4% between Auto and manual EPAP
次要结局
- Apnea Hypopnea Index (AHI)(Overnight, up 8 hrs on night 1 and 2)
- Arterial Carbon Dioxide (PCO2)(Overnight, up 8 hrs on night 1 and 2)
- Sleep Efficiency (%)(Overnight, up to 8 hrs on nights 1 and 2)
- Nadir Arterial Oxygen Saturation (SpO2)(Overnight, up 8 hrs on night 1 and 2)