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ChildMask - protective mask for children / adolescents with improved wearing comfort and infection protection - in relation to Covid 19 and other infectious diseases - a follow-up

Not Applicable
Conditions
o ICD 10-coded disease, examination of healthy subjects
Registration Number
DRKS00034563
Lead Sponsor
niversitätsklinik für Kinder- und Jugendmedizin Bochum
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Pending
Sex
All
Target Recruitment
40
Inclusion Criteria

healthy

Exclusion Criteria

chronical diseases

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Primary endpoint: <br>Carbon dioxide partial pressure in mmHg measured in ABG before and after treadmill exercise<br>Hypothesis I: According to current studies, the type of mask investigated does not result in significant carbon dioxide retention or a significant drop in oxygen saturation during exercise on the treadmill, and is therefore not medically inferior to exercise without a mask.
Secondary Outcome Measures
NameTimeMethod
Secondary endpoint: <br>Oxygen saturation in % measured with a pulse oximetry device during treadmill exercise. <br>Wearing comfort of an FFP2 mask adapted to children using standardized questionnaires on mask wearing comfort and symptoms when wearing the mask at the beginning and at the end of the one-hour test.<br>Hypothesis II: Increased wearing comfort improves the acceptance of wearing a mask in children and adolescents.
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