Autotitrating Non-invasive Ventilation (NIV) Versus Standard NIV; a Randomised Crossover Trial in Patients With Newly Diagnosed Hypoventilation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- ResMed
- 入组人数
- 23
- 试验地点
- 2
- 主要终点
- Overnight Mean Oxygen Saturation
研究概览
简要总结
The aim of the study is to compare the efficacy and tolerance of autotitrating non-invasive ventilation (NIV) versus standard NIV in patients with newly diagnosed nocturnal hypoventilation who have never experienced nocturnal, home NIV.
详细描述
The aim of the study is to compare the effect of two types of noninvasive ventilator (a small machine that assists breathing) in patients newly diagnosed with nocturnal hypoventilation who are inexperienced in the use of noninvasive ventilation (NIV). NIV is standard therapy for patients with nocturnal hypoventilation.
The most common type of NIV is bilevel pressure support which assists patient breathing by delivering different levels of air pressure during inspiration and expiration via a mask covering the nose or nose and mouth. Standard bilevel NIV (VPAP™) has been further developed to create a new automatically adjusting NIV (AutoVPAP™). Automatically adjusting NIV varies the inspiratory air pressure according to the airflow rates generated by the patient. This may improve patient comfort, hours of NIV use and recovery time.
Patients over the age of 18 referred to, or under follow up at, the Royal Brompton Hospital who require domiciliary NIV but are inexperienced with use of NIV will be considered for entry into this randomised crossover study. If eligible for inclusion and willing to take part patients will be setup on automatically adjusting NIV or standard NIV, assigned in random order. At the end of one month the patient will be swapped to the alternative NIV for a further one month of domiciliary NIV treatment. At the end of each one month treatment period the patient will undergo overnight polysomnography, transcutaneous CO2 monitoring and 24 hour Holter monitoring.
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
- Single (Outcomes Assessor)
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
- •new clinical diagnosis of nocturnal hypoventilation
- •requirement for long-term domiciliary non-invasive ventilation
- •no previous experience with domiciliary non-invasive ventilation
排除标准
- •uncontrolled cardiac failure
- •acute exacerbation of respiratory failure
- •daytime resting PaO2 < 7.5kPa
- •moderate or severe bulbar weakness
- •inability to understand rationale and/or consent form for study
结局指标
主要结局
Overnight Mean Oxygen Saturation
时间窗: 4 weeks
Overnight oximetry (SaO2) and transcutaneous capnography (PtcCO2) (TOSCA, Linde Medical Sensors, Switzerland) were performed during a sleep a on NIV at the end of each month's NIV therapy.
次要结局
- Overnight Mean Transcutaneous Carbon Dioxide(4 weeks)
- Sleep Quality: Arousal Index(4 weeks)
- Oxygen Desaturation Index (>4%)(4 weeks)
- Overnight Peak Transcutaneous Carbon Dioxide(4 weeks)