NCT05742880

Effect of Face Masks on Pulmonary Function in Patients With COPD

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Medical University of Vienna · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• COPD
• Walking, Difficulty

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	6 Minute Walking Test	6 Minute walking test
DIAGNOSTIC_TEST	Blood gas analysis	Blood gas analyisis
PROCEDURE	Wearing a Surgical Facemask	Wearing a Surgical Facemask
PROCEDURE	Wearing a FFP2- Facemask	Wearing a FFP2- Facemask
PROCEDURE	Wearing no Mask	Wearing no Mask

Timeline

• Start date: 2022-11-01
• Primary completion: 2025-12-01
• Completion: 2025-12-01
• First posted: 2023-02-24
• Last updated: 2024-03-19

Locations

1 site across 1 country: Austria