High Intensity Non-Invasive Positive Pressure Ventilation (HINPPV) for Stable Hypercapnic Chronic Obstructive Pulmonary Disease (COPD) Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Daytime Partial Pressure of Carbon Dioxide in Arterial Blood (PaCO2)
研究概览
简要总结
The purpose of this pilot study is to evaluate the effect of high intensity non-invasive positive pressure ventilation (HINPPV) for stable, hypercapnic COPD patients. The investigators believe that HINPPV, used at least 6 hours nocturnally over three months, will benefit the stable hypercapnic COPD patient through a reduction in the daytime partial pressure of carbon dioxide in arterial blood (PaCO2) levels.
详细描述
The High Intensity Non-invasive Positive Pressure trial is a single arm interventional study. The purpose of this study is to evaluate the effect of High Intensity Non-invasive ventilation (HINPPV) in stable Chronic Obstructive Pulmonary patients with chronically elevated carbon dioxide levels. Participants will undergo various testing ( arterial blood gas (ABG), Pulmonary Function Test (PFTs), Polysomnography (PSGs), 6 minute walk tests)over a 3 month period to determine if this type of therapy will improve daytime carbon dioxide levels. The participants will also complete quality of life questionnaires to help ascertain improvements in their daily living activities.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 80 Years（Child, 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
High Intensity Non Invasive Pos.Pressure
The High Intensity Non-invasive Pos.Pressure trial is a single arm interventional study. Hypercapnic COPD participants that meet eligibility criteria will receive high intensity non-invasive positive pressure ventilation (HINPPV) for 90 days. Participants will receive HINPPV via bilevel positive airway pressure (BiPAP Synchrony) if they require an inspiratory positive airway pressure (IPAP) less than or equal to 30 cmH2O (centimeters of water); or the Trilogy ventilator if they require an IPAP greater than 30 cmH2O.
干预措施: Bilevel positive airway pressure (BiPAP) (Device)
结局指标
主要结局
Daytime Partial Pressure of Carbon Dioxide in Arterial Blood (PaCO2)
时间窗: Before and after 3 months of therapy
Daytime PaCO2 levels assessed after using high intensity non-invasive positive pressure ventilation (HINPPV) are compared to the participants' baseline daytime PaCO2 levels.
次要结局
- Exercise Capacity(Before and after 3 months of therapy)
- Dyspnea at Rest and With Exertion(Before and after 3 months of therapy)
- Maximal Inspiratory Pressure(Before and after 3 months of therapy)
- Efficiency of Sleep(Before and after 3 months of therapy)
- Health Status(Before and after 3 months of therapy)
- Sleepiness(Before and after 3 months of therapy)
- Duration of Sleep(Before and after 3 months of therapy)