NCT01596023已完成不适用
Evaluation of Effect of Breathe Ventilation System on Work of Breathing in COPD Patients
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 2
- 主要终点
- Pressure time product of the diaphragm (PTPdi) during use of the Breathe Ventilation System
研究概览
简要总结
The Breathe Ventilator is a lightweight, wearable ventilator that has received U.S. FDA clearance for use in patients with respiratory difficulty. The investigators believe that the Breathe NIOV system will reduce the work of the diaphragm and breathing by providing added tidal volume and oxygen. This will be a study in 14 patients with severe-to-very severe chronic obstructive lung disease (COPD) to assess their work of breathing while using the NIOV system as measured by esophageal and stomach pressures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- Single (Participant)
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
- •Subject is >18 years of age at time of consent.
- •Subject has diagnosis of severe COPD (GOLD stage III or IV) as demonstrated by a FEV1 < 50% predicted and FEV1/FVC ratio < 70% predicted.
- •Subject has increased inspiratory muscle work of breathing as evidenced by palpable sternocleidomastoid muscle contraction during inspiration
排除标准
- •Subject has acute exacerbation of COPD - within 1 week of acute hospitalization
- •Subject has respiratory rate at rest > 28/min
- •Subject requires > 5 L/min nasal O2/min to maintain O2sat > 90%
- •Subject has severe dyspnea at rest
- •Subject has swallowing disorders or chronic aspiration, prior esophageal surgery, or any other condition that would place the subject at risk during balloon placement.
- •Subject has history of pneumothorax secondary to lung bullae.
- •Subject is too cognitively impaired to give subjective ratings for visual analog scale
- •Subject has sensitivity or an allergy to lidocaine
- •Subject has known history of oxygen intolerance.
结局指标
主要结局
Pressure time product of the diaphragm (PTPdi) during use of the Breathe Ventilation System
时间窗: 10 min
Calculated using the area of the transdiaphragmatic pressure for the duration of inspiration
次要结局
- Changes in PTP of the esophagus (PTPes), PTP per minute (PTPdi/min and PTPes/min(10 Min)
研究者
研究点 (2)
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