Effect of Face Masks on Pulmonary Function in Patients With COPD
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Walking distance
研究概览
简要总结
Given the heightened vulnerability of COPD patients to severe illness upon SARS-CoV-2 infection, precautions like mask-wearing are deemed crucial. Yet, mask-wearing can exacerbate breathlessness and discomfort in this demographic. This study aims to assess the effects of wearing a face mask during 6-Minute-Walking-Tests (6-MWT) among COPD patients.
详细描述
In this detailed study, we aim to explore the impact of wearing face masks on COPD patients during 6-Minute-Walking-Tests (6MWT). COPD, commonly observed among smokers and former smokers, poses heightened mortality risks upon SARS-CoV-2 infection. Consequently, face masks are often recommended for preventive measures. However, breathlessness remains a predominant symptom in this patient cohort. Moreover, there is a dearth of data concerning blood oxygenation levels while wearing various types of face masks.
The study will involve COPD patients who will undergo three 6MWTs: one without a mask, one with a simple face mask, and one with a FFP2 mask. Prior to each 6MWT, comprehensive pulmonary function tests including spirometry, body plethysmography, and CO-diffusion capacity measurement will be conducted. Additionally, capillary blood gas analysis will be performed both before the 6MWT and after each test session.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •COPD Diagnosis
- •Vaccinated against SARS-CoV 2
排除标准
- •Known cardial insufficency
- •Long term oxgenation therapy
- •immobility
- •Pregnancy
研究组 & 干预措施
Without Facemask
Wearing no mask.
干预措施: 6 Minute Walking Test (Diagnostic Test)
Without Facemask
Wearing no mask.
干预措施: Blood gas analysis (Diagnostic Test)
Without Facemask
Wearing no mask.
干预措施: Wearing no Mask (Procedure)
Wearing a Facemask
Wearing a surgical facemask
干预措施: 6 Minute Walking Test (Diagnostic Test)
Wearing a Facemask
Wearing a surgical facemask
干预措施: Blood gas analysis (Diagnostic Test)
Wearing a Facemask
Wearing a surgical facemask
干预措施: Wearing a Surgical Facemask (Procedure)
Wearing a FFP2-Mask
Wearing a FFP2- Mask
干预措施: 6 Minute Walking Test (Diagnostic Test)
Wearing a FFP2-Mask
Wearing a FFP2- Mask
干预措施: Blood gas analysis (Diagnostic Test)
Wearing a FFP2-Mask
Wearing a FFP2- Mask
干预措施: Wearing a FFP2- Facemask (Procedure)
结局指标
主要结局
Walking distance
时间窗: 6 minutes
Walking distance in meters during a 6 minute walking test
次要结局
- pO2(6 minutes)
- Heart rate(6 minutes)
- Blood oxygenation(6 minutes)
研究者
Lukasz Antoniewicz
MD, PhD
Medical University of Vienna
