Nasal High Flow (NHF) in COPD - Effects on Ventilation With Asymmetrical Nasal Cannulas (NHFDuet)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Change in minute ventilation (MV) comparing arm 1 and 2
研究概览
简要总结
The aim of this controlled randomized crossover study is to compare the physiological effects of nasal high flow therapy (NHF) with 2 different nasal cannulas in patients with exacerbated chronic obstructive pulmonary disease (ECOPD) and chronic respiratory failure.
20 patients will be treated with NHF therapy (Airvo, Fisher&Paykel Healthcare, NZ) during wakefulness. Physiological measuremends will take place over three perdiods (visits). One period without NHF, one with NHF via standard cannula (Optiflow M) and one with asymmetrical cannula (Optiflow Duet) in randomised order.
详细描述
Background: Nasal High Flow (NHF) therapy had shown to increase airway pressure, reduce dead space, and improve mucociliary clearance and gas exchange in patients suffering from chronic obstructive pulmonary disease (COPD). The long-term and short-term physiological aspects of NHF are subject of ongoing research. Different flow rates and cannula sizes have been studied and found to yield different therapeutic effects. Larger sized cannulas tend to seal the nares and produce increased positive airway pressure, while smaller cannulas increase the washout effect. Currently, a new cannula is available, with one smaller and one larger opening (Optiflow+ Duet, Fisher&Paykel Healthcare, NZ).
Procedure: Following a baseline period without high flow therapy, NHF (35L/min) will be applied via the nasal cannula (Duet or Standard in randomized order). After a wash out phase, the NHF interface will be replaced for another measurement with the respective other cannula (Standard or Duet).
Respiratory rate, tidal volume, minute ventilation, inhalation to exhalation ratio (Ti/Te), transcutaneous pCO2 and intercostal EMG will be recorded during each partial measurement.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inpatients with COPD GOLD 3 and 4 in stable phase after acute exacerbation
- •Inpatients with COPD GOLD (2, 3 and 4)
- •Informed Consent
排除标准
- •Acute respiratory insuffiency with respiratory acidosis (pH<7.35)
- •Severe acute physical disease, that do not allow the subject to participate in a clinical trial
- •Language, cognitive, or other barriers that make study participation impossible
- •Pregnancy or Nursing
结局指标
主要结局
Change in minute ventilation (MV) comparing arm 1 and 2
时间窗: 1.5 hours
Respiratory effort measured with calibrated RIP system (Respitrace QDC; Viasys Services, Lakeland, FL), MV is calculated. Unit is L
次要结局
- Change in respiratory rate (RR) comparing arm 1 and 2(1.5 hours)
- Change in inhalation to exhalation ratio (Ti/Te) comparing arm 1 and 2(1.5 hours)
研究者
Georg Nilius, Prof. Dr. med
Head of Department of Pneumology, PI
Kliniken Essen-Mitte