German: Einfluss Von Gesichertem Atemminutenvolumen Auf Schlafqualität Und Häufigkeit Respiratorischer Ereignisse Bei Patienten Mit Nicht Invasiver Beatmung (NIV)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 21
- 试验地点
- 2
- 主要终点
- Number of respiratory events during non invasive ventilation
研究概览
简要总结
Aim of this prospective randomized trial is to compare non invasive ventilation (NIV) with pressure control (BiPAP-ST) to volume assured pressure support (iVAPS) with regards to sleep quality and alveolar ventilation in patients with routine NIV initiation after COPD exacerbation.
20 patients with COPD and chronic hypercapnic respiratory failure will spent two nights on NIV, one with spontaneous timed pressure controlled bilevel ventilation (BiPAP-ST) and one with the advanced mode of intelligent volume assured pressure support (iVAPS). Patients will spend the treatment nights in randomized order under polysomnographic surveillance, including transcutaneous PCO2 measurement. Besides the number of arousals and PCO2 values over night the sleep quality will be judged with regards to especially adjusted respiratory event criteria like unintentional leaks, patient ventilator asynchrony, and decrease of ventilatory drive.
详细描述
Non invasive ventilation (NIV) is one of the major medical innovations of the last 30 years. Especially continuous positive airway pressure (CPAP) is the established Gold Standard in obstructive sleep apnea (OSA) treatment.
NIV with bilevel ventilation (BiPAP-ST) is the established Gold Standard in acute hypercapnic respiratory failure, especially in exacerbated COPD.
Still, the adaption of CPAP in OSA is less complicated than a bilevel therapy in hypercapnic failure. The adjustment of NIV requires not only the definition of expiration pressure (PEEP) but also of inspiration pressure support. Only adequate pressure difference guarantees effective ventilatory assistance and an improvement of alveolar ventilation. The pressure changes need to be defined by the physician, as well as the breathing frequency.
Ventilation can furthermore be controlled by a target volume (volume controlled) or a target pressure (pressure controlled).
Moreover, patients with respiratory insufficiency are often suffering of significant dyspnoea and are hard to accustom to a respiratory mask.
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
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Stable respiratory insufficiency
- •Hypercapnia >50 mmHG
- •Clinically required NIV
- •Capable of giving consent
排除标准
- •Existing ventilatory support
- •Invasive ventilation
- •Any other severe physical disease that requires immediate medical assistance
- •Acute hypercapnic decompensation with pH <7.30 in routine BGA
- •Circumstances that doesn't allow mask ventilation (e.g. facial deformation)
- •Participation in a clinical trial within the last 4 weeks
- •Pregnancy or nursing period
- •Drug addiction
结局指标
主要结局
Number of respiratory events during non invasive ventilation
时间窗: 2 nights
Unintentional leak, patient ventilator asynchrony, decrease of ventilatory drive, Apnoea, Hypopnea
次要结局
- Sleep efficiency(2 nights)
研究者
Georg Nilius
PD Dr. med.
Helios Klinik Ambrock