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

Completed

• Conditions: Longterm Oxygen Therapy; Face Mask
• Interventions: Diagnostic Test: 6-MWT; Diagnostic Test: Spiroergometry

• Registration Number: NCT05931016
• Lead Sponsor: University Hospital Regensburg

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-06-26
• Study First Submitted: 2023-06-26
• Study First Submitted QC: 2023-06-26
• Study First Posted: 2023-07-05
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-01
• Last Update Posted: 2024-02-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with known lung disease and LTOT (long term oxygen therapy)	6-MWT	Patients with i.e. interstitial lung, emphysema, pulmonary hypertension or COPD with the need for LTOT
Patients with known lung disease and LTOT (long term oxygen therapy)	Spiroergometry	Patients with i.e. interstitial lung, emphysema, pulmonary hypertension or COPD with the need for LTOT

Primary Outcome Measures

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

Trial Locations

Locations (1)

Klinik Donaustauf; 🇩🇪 Donaustauf, Bavaria, Germany