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OpenTrials
Completed

NCT Number: NCT05931016

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

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.

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Key information

Conditions

Face Mask Longterm Oxygen Therapy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Klinik Donaustauf

Donaustauf, Bavaria, 93093, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

6-MWT

Diagnostic Test

Measurement of saturation and blood gas parameters under 6-MWT with different masks.

Other names: Six minutes walk test

Spiroergometry

Diagnostic Test

Measurement of saturation and blood gas parameters under spiroergometry with different masks.

Primary outcomes

  1. Increase in capillary oxygen partial pressure

    Time frame: At the end of 6-MWT or spiroergometry

  2. Increase in capillary carbon dioxide partial pressure

    Time frame: At the end of 6-MWT or spiroergometry

Sponsors and collaborators

Lead sponsor

University Hospital Regensburg

Other

Registry information

Official study 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

Acronym: FFP-O2

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jul 5, 2023
Registry last updated
Feb 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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