Effect of Face Masks on Pulmonary Function in Patients With COPD
Primary Purpose
COPD, Walking, Difficulty
Status
Recruiting
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
Wearing a mask
Sponsored by
About this trial
This is an interventional diagnostic trial for COPD
Eligibility Criteria
Inclusion Criteria: COPD Diagnosis Vaccinated against SARS-CoV 2 Exclusion Criteria: Known cardial insufficency Long term oxgenation therapy immobility BMI >35 Pregnancy
Sites / Locations
- Medical University of Vienna, Dept. of Internal Medicine II, Div. of PulmonologyRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
No Intervention
Active Comparator
Active Comparator
Arm Label
Without Facemask
Wearing a Facemask
Wearing a FFP2-Mask
Arm Description
Outcomes
Primary Outcome Measures
Walking distance
Walking distance in meters during a 6 minute walking test
Secondary Outcome Measures
Blood oxygenation
Blood oxygenation
Dyspnea
Dyspnea on BORG scale
Heart rate
Heart rate in bpm
pO2
pO2
Full Information
NCT ID
NCT05742880
First Posted
February 14, 2023
Last Updated
February 14, 2023
Sponsor
Medical University of Vienna
1. Study Identification
Unique Protocol Identification Number
NCT05742880
Brief Title
Effect of Face Masks on Pulmonary Function in Patients With COPD
Official Title
Effect of Face Masks on Pulmonary Function in Patients With COPD
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2022 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Vienna
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Since COPD patients are at higher risk for severe illness in case of SARS-CoV-2-infection, precautions such as wearing masks are important for them. However, for this group of patients wearing a mask can lead to increased shortness of breath and discomfort.
Aim of this study is to examine the impact of wearing a face mask during 6-Minute-Walking-Tests (6-MWT) in COPD patients.
Detailed Description
Chronic obstructive pulmonary disease (COPD) is a common disease among smokers and former smokers. Patients with COPD have an increased mortality risk when infected by the SARS-CoV-2 virus. Therefore face-masks are often recommended as a preventive method. However, shortness of breath is the leading symptom in this patient group. Furthermore, no data regarding blood oxygenation while wearing different kinds of face-masks is available.
In the present study we will investigate patients with COPD, wearing two different face-masks, while performing a 6-minutes-walking-test (6MWT). I summary three 6MWTs will be performed: without a mask, with a simple face-mask, with a FFP2 mask. Prior to the 6 minute walking test, a pulmonary function test with spirometry, bodyplethysmography and CO-Diffusion capacity measurement will be performed. Additionally capillary blood gas analysis will be performed prior to the 6MWT and following each test.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COPD, Walking, Difficulty
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Without Facemask
Arm Type
No Intervention
Arm Title
Wearing a Facemask
Arm Type
Active Comparator
Arm Title
Wearing a FFP2-Mask
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Wearing a mask
Intervention Description
6 Minute walking test while wearing a Mask
Primary Outcome Measure Information:
Title
Walking distance
Description
Walking distance in meters during a 6 minute walking test
Time Frame
6 minutes
Secondary Outcome Measure Information:
Title
Blood oxygenation
Description
Blood oxygenation
Time Frame
6 minutes
Title
Dyspnea
Description
Dyspnea on BORG scale
Time Frame
6 minutes
Title
Heart rate
Description
Heart rate in bpm
Time Frame
6 minutes
Title
pO2
Description
pO2
Time Frame
6 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
COPD Diagnosis
Vaccinated against SARS-CoV 2
Exclusion Criteria:
Known cardial insufficency
Long term oxgenation therapy
immobility
BMI >35
Pregnancy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lukasz Antoniewicz, MD, PhD
Phone
01-40400-47760
Email
lukasz.antoniewicz@meduniwien.ac.at
First Name & Middle Initial & Last Name or Official Title & Degree
Helia Rafsandjani, MD
Phone
01-40400-47760
Email
lukasz.antoniewicz@meduniwien.ac.at
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marco Idzko, Prof.
Organizational Affiliation
Medical University of Vienna
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Lukasz Antoniewicz, MD, PhD
Organizational Affiliation
Medical University of Vienna
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of Vienna, Dept. of Internal Medicine II, Div. of Pulmonology
City
Vienna
ZIP/Postal Code
1090
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lukasz Antoniewicz, MD, PhD
Phone
01-40400-47760
Email
lukasz.antoniewicz@meduniwien.ac.at
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effect of Face Masks on Pulmonary Function in Patients With COPD
We'll reach out to this number within 24 hrs