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

NCT ID: NCT05931016

Last Updated: 2024-02-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

72 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-06-26

Study Completion Date

2023-12-31

Brief Summary

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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

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Conditions

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Face Mask Longterm Oxygen Therapy

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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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

6-MWT

Intervention Type DIAGNOSTIC_TEST

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

Spiroergometry

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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6-MWT

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

Intervention Type DIAGNOSTIC_TEST

Spiroergometry

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

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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Six minutes walk test

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital Regensburg

OTHER

Sponsor Role lead

Responsible Party

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Maximilian Malfertheiner

PD Dr. Maximilian Malfertheiner

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Klinik Donaustauf

Donaustauf, Bavaria, Germany

Site Status

Countries

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Germany

Other Identifiers

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22-3165-101

Identifier Type: -

Identifier Source: org_study_id

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