Effect of Face Masks on Pulmonary Function in Patients With COPD

COPD Clinical Trial

Official title:

Effect of Face Masks on Pulmonary Function in Patients With COPD

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05742880
• Other study ID #: 1163/2022
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2022
• Est. completion date: December 2025

Study information

• Verified date: March 2024
• Source: Medical University of Vienna
• Contact: Lukasz Antoniewicz, MD, PhD
• Phone: 01-40400-47760
• Email: lukasz.antoniewicz[@]meduniwien.ac.at
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• COPD Diagnosis

• Vaccinated against SARS-CoV 2

Exclusion Criteria:

• Known cardial insufficency

• Long term oxgenation therapy

• immobility

• BMI >35

• Pregnancy

Related Conditions & MeSH terms

• COPD
• Mobility Limitation
• Walking, Difficulty

Intervention

Diagnostic Test:
• 6 Minute Walking Test
6 Minute walking test
• Blood gas analysis
Blood gas analyisis

Procedure:
• Wearing a Surgical Facemask
Wearing a Surgical Facemask
• Wearing a FFP2- Facemask
Wearing a FFP2- Facemask
• Wearing no Mask
Wearing no Mask

Locations

Country	Name	City	State
Austria	Medical University of Vienna, Dept. of Internal Medicine II, Div. of Pulmonology	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Walking distance	Walking distance in meters during a 6 minute walking test	6 minutes
Secondary	Blood oxygenation	Blood oxygenation	6 minutes
Secondary	Heart rate	Heart rate in bpm	6 minutes
Secondary	pO2	pO2	6 minutes