Evaluation of Automatic Expiratory Positive Airway Pressure (Auto-EPAP) for Management of Upper Airway Obstruction During Non-Invasive Ventilation With Vivo 45 LS
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 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.
研究概览
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Study subjects will be blinded to the sequence arm that they are randomized to. Investigators and site study staff will be unblinded. The scorer(s) of the polysomnography will be blinded to which therapy is being used for objective determination of the primary endpoint.
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 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.
- •Subject does not comprehend English.
- •Subject is unable or unwilling to provide written informed consent.
- •Subject is physically and/or mentally unable to comply with the protocol.
- •Subject is not suitable to participate in the trial for any other reason in the opinion of the investigator.
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 (Device)
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 (Device)
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
次要结局
未报告次要终点