Efficacy and Physiology of Nasal High Flow Therapy (AIRVO2™, Fisher&Paykel) in Patients With Chronic Obstructive Pulmonary Disease (COPD) and Chronic Hypercapnic Respiratory Failure
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 46
- 试验地点
- 2
- 主要终点
- mean overnight transcutaneous PCO2
研究概览
简要总结
The effects of a nasal high-flow (NHF) therapy in patients with chronic obstructive hypercapnic respiratory failure are still not sufficiently known yet.
The aim of this study is a step-by-step generation of physiological data about gas exchange and respiration under high flow therapy using a nasal cannula with an AIRVO 2 device to provide NHF, leading to an analysis of the effects of high flow on PCO2 levels, exercise capacity, quality of life and gas exchange in a long term home treatment compared to a standard low flow long term oxygen therapy (LOT).
Hypothesis: NHF and LOT therapy show differences in measured mean overnight transcutaneous carbon dioxide partial pressure (PCO2) after four weeks of treatment.
详细描述
Stage 1: Respiratory Physiology. Aim of this Stage is to investigate the effects of nasal High Flow (NHF) therapy in patients in progressed stages of COPD, by measuring physiologic parameters like tidal volume, breathing frequency and expiratory PCO2 concentration.
Stage 2: Efficacy of short term NHF. Aim of this Stage is to evaluate the efficacy of two flow rates (20 L/min and 35 L/min) regarding alveolar ventilation in overnight therapy. For this reason, patients will have two PSG sleep studies during their hospital stay, under 20 L/min and 35 L/min NHF therapy in randomized order.
Stage 3: Home Care monitoring. Aim of this Stage is to compare long term influences of NHF and LOT on PCO2 levels randomised crossover, 4 weeks each treatment.
Stage 4: Long Term Home Care monitoring . Aim of this stage is the long term follow up (12 month) of patients to examine the compliance of a sufficient NHF therapy. Patients will retain the NHF therapy if they are responders (PCO2 improvement in stage 3 of at least 2 mmHG with NHF versus LOT) and willing and able to use NHF and a patient log.
All patients will be monitored for the next 12 month. After 6 month there will be a control phone call.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 40-80
- •Male and female
- •COPD patients with chronic respiratory insufficiency (pH >7.35 and PCO2 > 50mmHg)
- •Stable respiratory situation
排除标准
- •Decompensated heart, liver or kidney failure.
- •Pregnancy or nursing period
- •Participation in another clinical trial within the last 4 weeks
- •Drug abuse
- •Incapable of giving consent
- •Known obstructive sleep apnea syndrome (OSA) (AHI>10)
- •noninvasive ventilation (NIV) therapy
研究组 & 干预措施
nasal High Flow and Oxygen
overnight nasal High Flow (NHF) therapy+ individually titrated supplemental oxygen (2-6 L/min),total 35 L/min, 4 weeks at home
干预措施: NHF therapy (Device)
nasal High Flow and Oxygen
overnight nasal High Flow (NHF) therapy+ individually titrated supplemental oxygen (2-6 L/min),total 35 L/min, 4 weeks at home
干预措施: Long term Oxygen Therapy (LOT) (Other)
Long term Oxygen Therapy (LOT)
individually titrated supplemental oxygen (2-6 L/min), 4 weeks at home
干预措施: Long term Oxygen Therapy (LOT) (Other)
结局指标
主要结局
mean overnight transcutaneous PCO2
时间窗: after 12 month
All patients will be monitored under NHF or another sufficient therapy for the next 12 month followed by another mean overnight transcutaneous PCO2 level measure.
次要结局
- quality of life with Saint Georges Respiratory Questionnaire (SGRQ)(after 4 weeks, 8 weeks and 12 month)
研究者
Georg Nilius
Head of pneumologic department of Helios Klinik Hagen
Helios Klinik Ambrock