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临床试验/NCT05742880
NCT05742880Unknown不适用

Effect of Face Masks on Pulmonary Function in Patients With COPD

Medical University of Vienna1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2022年11月1日最近更新:
适应症
干预措施

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

Sham Comparator

Wearing no mask.

干预措施: 6 Minute Walking Test (Diagnostic Test)

Without Facemask

Sham Comparator

Wearing no mask.

干预措施: Blood gas analysis (Diagnostic Test)

Without Facemask

Sham Comparator

Wearing no mask.

干预措施: Wearing no Mask (Procedure)

Wearing a Facemask

Active Comparator

Wearing a surgical facemask

干预措施: 6 Minute Walking Test (Diagnostic Test)

Wearing a Facemask

Active Comparator

Wearing a surgical facemask

干预措施: Blood gas analysis (Diagnostic Test)

Wearing a Facemask

Active Comparator

Wearing a surgical facemask

干预措施: Wearing a Surgical Facemask (Procedure)

Wearing a FFP2-Mask

Active Comparator

Wearing a FFP2- Mask

干预措施: 6 Minute Walking Test (Diagnostic Test)

Wearing a FFP2-Mask

Active Comparator

Wearing a FFP2- Mask

干预措施: Blood gas analysis (Diagnostic Test)

Wearing a FFP2-Mask

Active Comparator

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

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

Lukasz Antoniewicz

MD, PhD

Medical University of Vienna

研究点 (1)

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