Evaluation of Automatic Expiratory Positive Airway Pressure (Auto-EPAP) for Management of Upper Airway Obstruction During Non-Invasive Ventilation With Vivo 45 LS
概览
- 阶段
- 不适用
- 干预措施
- Non-Invasive Ventilation
- 疾病 / 适应症
- Obstructive Sleep Apnea
- 发起方
- Breas Medical, Inc.
- 入组人数
- 23
- 试验地点
- 4
- 主要终点
- Exploratory effectiveness endpoint is to evaluate the subject's mean Oxygen Desaturation Index (ODI4%) during each overnight polysomnography assessment.
- 状态
- 已完成
- 最后更新
- 3个月前
概览
简要总结
To evaluate the safety and effectiveness of the Automatic Expiratory Positive Airway Pressure (Auto-EPAP) feature versus manual expiratory positive airway pressure (EPAP) in the Vivo 45 LS Ventilator.
研究者
入排标准
入选标准
- •Subject has the ability to provide written informed consent.
- •Subject is ≥ 18 years old.
- •Subject has documented respiratory failure (e.g. sleep hypoventilation with historical transcutaneous carbon dioxide (PtCO2) increase ≥ 10mmHg) and/or daytime hypercapnia (\>45 mmHg).
- •Subject is currently using non-invasive positive pressure ventilation (NIV) for 1 month.
- •Subject has a previously documented apnea-hypopnea index (AHI) ≥ 5/hr.
- •Subject's expiratory positive airway pressure (EPAP) settings were recently (≤ 12 months) reviewed.
排除标准
- •Subject is not compliant on NIV (e.g., \< 4 hr./night).
- •Subject is pregnant.
- •Subject is on oxygen therapy ≥ 5 L/min.
- •Subject has an invasive interface (e.g. tracheostomy).
- •Subject has had an acute exacerbation within the last 3 months that resulted in a hospitalization.
- •Subject is acutely ill, medically complicated, or who are medically unstable.
- •Subject in whom NIV therapy is otherwise medically contraindicated.
- •Subject has had surgery of the upper airway, nose, sinus, or middle ear within the previous 90 days.
- •Subjects with untreated, non-obstructive sleep apnea (OSA) sleep disorders, including but not limited to: insomnia, periodic limb movement syndrome, or restless leg syndrome.
- •Subjects who have the following pre-existing conditions: severe bullous lung disease, recurrent pneumothorax or pneumomediastinum, cerebrospinal fluid leak, or recent cranial surgery or trauma.
研究组 & 干预措施
Auto Night One, Manual Night Two
Will undergo Automatic Expiratory Positive Airway Pressure (EPAP) during Non-Invasive Ventilation in polysomnography (PSG) Night 1; Will undergo Manual EPAP during Non-Invasive Ventilation in PSG Night 2
干预措施: Non-Invasive Ventilation
Manual Night One, Auto Night Two
Will undergo Manual Expiratory Positive Airway Pressure (EPAP) during Non-Invasive Ventilation in polysomnography (PSG) Night 1; Will undergo Auto-EPAP during Non-Invasive Ventilation in PSG Night 2
干预措施: Non-Invasive Ventilation
结局指标
主要结局
Exploratory effectiveness endpoint is to evaluate the subject's mean Oxygen Desaturation Index (ODI4%) during each overnight polysomnography assessment.
时间窗: Up to Five Weeks
The log of the subject's mean Oxygen Desaturation Index (ODI4%) measured during each overnight polysomnography assessment (i.e., log10 (mean+1)).
Exploratory effectiveness endpoint is to evaluate the log of the subject's mean Apnea Hypopnea Index (AHI) during each overnight polysomnography assessment.
时间窗: Up to Five Weeks
The log of the subject's mean Apnea Hypopnea Index (AHI) measured during each overnight polysomnography assessment (i.e., log10 (mean+1)).
The primary safety endpoint is the occurrence of device-related serious adverse events (SADEs).
时间窗: Up to Five Weeks