Physiological Study to Compare Noninvasive Ventilation (NIV) Masks
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Transcutaneous carbon dioxide
研究概览
简要总结
Noninvasive ventilation (NIV) is an established therapy that delivers positive pressure to the upper airways to provide respiratory support. Two types of NIV can be delivered; continuous positive airway pressure (CPAP) at one continuous pressure and bilevel NIV at two pressures for inhalation and exhalation.
This investigation is designed to physiologically evaluate the performance of a NIV mask, Mask A, compared to a standard NIV mask, Mask B on CPAP therapy.
People with sleep disordered breathing who have chronic hypercapnia, and are already receiving nocturnal CPAP will be recruited. They will receive one night's CPAP therapy on Mask A and 1 night on Mask B in random order. Physiological parameters will be recorded.
Parameters will be recorded during three baselines at the beginning of each evening and throughout the night when participants are asleep. The three baselines are:
- participant awake with normal breathing (not on CPAP),
- participant awake and on CPAP, and
- participant asleep on CPAP in REM-sleep (rapid eye movement sleep).
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
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Already using overnight CPAP and tolerating the therapy well (over 4 hours use/night)
- •Hypercapnia: venous bicarbonate of 30 milliequivalents of solute per liter (Eq/L) or more, OR transcutaneous carbon dioxide (TcCO2) of 50 millimeters of mercury (mmHg) of more.
- •Provide written informed consent
- •Already use a full (oronasal) face mask for CPAP
- •Willing to have a venous blood sample taken during the pre-screening visit.
排除标准
- •Presence of sleep apnea on CPAP:
- •Subjects excluded if they have an apnea-hypopnea index (AHI) of more than 20, or
- •If the AHI has not already decreased by 50 percent or more from pre-CPAP to with CPAP.
- •Forced expiratory volume in 1 second (FEV1) of less than 40 percent of predicted.
- •Forced expiratory volume in 1 second divided by forced vital capacity (FEV1/FVC) less than fifty percent of predicted, at the screening visit.
- •Have poorly controlled asthma or changing asthma symptoms.
- •Nasal obstruction
- •Do not fit Mask A or Mask B
- •Agitation or psychological illness
结局指标
主要结局
Transcutaneous carbon dioxide
时间窗: 1 day (From baseline to the end of the study night)
The change in transcutaneous carbon dioxide from the 3 different baselines to the transcutaneous carbon dioxide during non-REM sleep on CPAP on the same study night. Three different values will be determined for each mask.
次要结局
未报告次要终点