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临床试验/NCT05931016
NCT05931016已完成不适用

Impact of Surgical Mask, FFP2 (Filtering Face Piece Class 2) Mask and FFP3 (Filtering Face Piece Class 3) Mask (With and Without Exhalation Valve) on Exercise Tolerance and Blood Gas Parameters of Patients With Known Lung Disease and Long-term Oxygen Therapy

University Hospital Regensburg1 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2023年6月26日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
72
试验地点
1
主要终点
Increase in capillary oxygen partial pressure

研究概览

简要总结

The aim of the study is to find out how blood gas parameters change under the use of surgical mask, FFP2 masks and FFP3 masks (with and without exhalation valve) in patients with known lung disease and long-term oxygen therapy.

In particular, the question arises whether patients become hypoxemic or hypercapnic by using a mask. Or whether wearing a mask increases oxygen saturation by its reservoir function.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Known lung disease and
  • informed consent

排除标准

  • Severe disease with contraindication for stress testing (e.g. myocardial infarction, acute pulmonary embolism, acute heart failure)
  • Acute exacerbation of lung disease

结局指标

主要结局

Increase in capillary oxygen partial pressure

时间窗: At the end of 6-MWT or spiroergometry

Increase in capillary carbon dioxide partial pressure

时间窗: At the end of 6-MWT or spiroergometry

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Maximilian Malfertheiner

PD Dr. Maximilian Malfertheiner

University Hospital Regensburg

研究点 (1)

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