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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05931016

Acronym

FFP-O2

Enrollment

Registered

2023-07-05

Start date

2023-06-26

Completion date

2023-12-31

Last updated

2024-02-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Face Mask, Longterm Oxygen Therapy

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.

Interventions

DIAGNOSTIC_TEST6-MWT

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

DIAGNOSTIC_TESTSpiroergometry

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

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Increase in capillary carbon dioxide partial pressure	At the end of 6-MWT or spiroergometry
Increase in capillary oxygen partial pressure	At the end of 6-MWT or spiroergometry

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026