Effects of an Oxymizer® During Daytime in Patients With Pulmonary Fibrosis (IPF)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Difference in oxygen saturation between Oxymizer and conventional nasal cannula
研究概览
简要总结
This study will investigate the effects of a reservoir nasal cannula (Oxymizer®) compared to a conventional nasal cannula (CNC) in patients with idiopathic pulmonary fibrosis.
详细描述
Patients will be recruited during a 3-week inpatient pulmonary rehabilitation program. They will perform the following three interventions on consecutive days and will repeat them after a week. During these days the time table for prescribed physical activities and therapies will be kept in a comparable fashion.
The following 3 interventions will be performed in randomized order:
Day A: The Patient wears a conventional nasal cannula for 12 h with oxygen flow rate as prescribed during ADL
Day B: The Patient wears the Oxymizer® with prescribed oxygen flow rate for 12 h during ADL
Day C: The patient wears the Oxymizer® with a flow rate reduced by 1l/min in comparison to the prescribed oxygen flow rate, for 12h
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •IPF patients with indication for long term oxygen therapy ≥ 2l/min
- •VC >30% and < 70% pred.
排除标准
- •failure to comply with study process
- •acute infection
研究组 & 干预措施
Oxymizer® compared to CNC
From 7am to 7pm oxygen saturation is measured by a pulse oximeter. One day with conventional nasal cannula, one day with Oxymizer®, one day with Oxymizer® and reduced Oxygen flow (-1l/min). The order of these days is randomized in 6 groups.
The intervention will be performed on consecutive days and twice during study period.
干预措施: Oxymizer® compared to CNC (Device)
结局指标
主要结局
Difference in oxygen saturation between Oxymizer and conventional nasal cannula
时间窗: day 1 to 13
Oxygen Saturation will be measured via pulseoxymetry for 12 hours. On 2 days, mean oxygen Saturation will be reported while using Oxymizer or a conventional nasal cannula, both with similar Oxygen flow. The difference of the mean Oxygen Saturation of 12 hours between both cannulae will be the Primary outcome.
次要结局
未报告次要终点
研究者
Klaus Kenn
Dr. med.
Schön Klinik Berchtesgadener Land