Optical Transcutaneous Sensors of Capnia and Oxygenation (NCT03992651) | Clinical Trial Compass
CompletedNot Applicable
Optical Transcutaneous Sensors of Capnia and Oxygenation
France20 participantsStarted 2019-06-12
Plain-language summary
This study aims at validating new optical transcutaneous sensors to evaluate tissue capnia (CO2 partial pressure) and oxygenation (blood oxygen saturation) by comparing them to standard laboratory measurements (end tidal CO2 measurements and oxygen saturation by near-infrared spectroscopy).
Who can participate
Age range18 Years – 50 Years
SexALL
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Inclusion Criteria:
* Males or females between 18 and 50 year old
* Individual having health insurance
* Individual able to provided informed consent
* Subjects with no known pathology and not taking any medical treatment a priori capable of interfering with controlled hypoxia at levels required in the protocol
Exclusion Criteria:
* Body mass index \>27 kg/m²
* History of acute mountain sickness
* Chronic diseases know to be associated with high methemoglobinemia
* Known allergy to one of the materials used in the devices (lycra, polyamide...), or to the adhesive plaster.
* Active smoker (\>3 cigarets/day)
* Alcohol consumption (\>10g/day)
* Individual with high skin sensitivity due to skin diseases
* Mental disorders
* Persons who refuse to sign the information sheet and participation agreement
* Persons under guardianship or not subject to a social security system
* Pregnant woman, parturient, breastfeeding mother
* Person deprived of liberty by judicial or administrative decision
* A person who is subject to a legal protection measure that cannot be included in clinical trials.
What they're measuring
1
Comparison of capnia values
Timeframe: Continuous measurement during the only experimental session (1 hour)