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FFP-O2: Impact of Surgical Mask, FFP2 Mask and FFP3 Mask (With and Without Exhalation Valve) on Exercise Tolerance and Blood Gas Parameters of Patients With Known Lung Disease and Long-term Oxygen Therapy

Sponsor
University Hospital Regensburg (Other)
Overall Status
Recruiting
CT.gov ID
NCT05931016
Collaborator
(none)
100
Enrollment
1
Location
15.2
Anticipated Duration (Months)
6.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The aim of the study is to find out how blood gas parameters change under the use of surgical mask, FFP2 masks and FFP3 masks (with and without exhalation valve) in patients with known lung disease and long-term oxygen therapy.

In particular, the question arises whether patients become hypoxemic or hypercapnic by using a mask. Or whether wearing a mask increases oxygen saturation by its reservoir function.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: 6-MWT
  • Diagnostic Test: Spiroergometry

Study Design

Study Type:
Observational
Anticipated Enrollment :
100 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Impact of Surgical Mask, FFP2 (Filtering Face Piece Class 2) Mask and FFP3 (Filtering Face Piece Class 3) Mask (With and Without Exhalation Valve) on Exercise Tolerance and Blood Gas Parameters of Patients With Known Lung Disease and Long-term Oxygen Therapy
Actual Study Start Date :
Jun 26, 2023
Anticipated Primary Completion Date :
May 31, 2024
Anticipated Study Completion Date :
Sep 30, 2024

Arms and Interventions

Arm Intervention/Treatment
Patients with known lung disease and LTOT (long term oxygen therapy)

Patients with i.e. interstitial lung, emphysema, pulmonary hypertension or COPD with the need for LTOT

Diagnostic Test: 6-MWT
Measurement of saturation and blood gas parameters under 6-MWT with different masks.
Other Names:
  • Six minutes walk test

    • Diagnostic Test: Spiroergometry
    Measurement of saturation and blood gas parameters under spiroergometry with different masks.

    Outcome Measures

    Primary Outcome Measures

    1. Increase of capillary pO2 [At the end of 6-MWT or spiroergometry]

    2. Increase of capillary pCO2 [At the end of 6-MWT or spiroergometry]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Known lung disease and

    • LTOT

    • informed consent

    Exclusion Criteria:

    • Severe disease with contraindication for stress testing (e.g. myocardial infarction, acute pulmonary embolism, acute heart failure)

    • Acute exacerbation of lung disease

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Klinik Donaustauf Donaustauf Bavaria Germany 93093

    Sponsors and Collaborators

    • University Hospital Regensburg

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Maximilian Malfertheiner, PD Dr. Maximilian Malfertheiner, University Hospital Regensburg
    ClinicalTrials.gov Identifier:
    NCT05931016
    Other Study ID Numbers:
    • 22-3165-101
    First Posted:
    Jul 5, 2023
    Last Update Posted:
    Jul 5, 2023
    Last Verified:
    Jun 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Lung Diseases

    Study Results

    No Results Posted as of Jul 5, 2023