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

NCT05931016 | Completed

• 1 other identifier: 22-3165-101
• Study Type: observational
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Face Mask; Longterm Oxygen Therapy

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

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; Diagnostic Test: Spiroergometry

Interventions

6-MWT DIAGNOSTIC_TEST

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

Also known as: Six minutes walk test

Patients with known lung disease and LTOT (long term oxygen therapy)

Spiroergometry DIAGNOSTIC_TEST

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

Patients with known lung disease and LTOT (long term oxygen therapy)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with known lung disease hospitalized at normal wards.

You may qualify if:

• Known lung disease and
• LTOT
• informed consent

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital Regensburg: lead

Study Sites (1)

Klinik Donaustauf

Donaustauf, Bavaria, 93093, Germany

Location

MeSH Terms

Interventions

Walk Test

Intervention Hierarchy (Ancestors)

Exercise Test; Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PD Dr. Maximilian Malfertheiner

Study Record Dates

• First Submitted: June 26, 2023
• First Posted: July 5, 2023
• Study Start: June 26, 2023
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: February 5, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)