Optical Transcutaneous Sensors of Capnia and Oxygenation

Study Overview
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Brief Summary
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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).

Official Title
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Validation of Optical Transcutaneous Sensors to Measure Capnia and Tissue Oxygenation

Conditions
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Blood Gas Monitoring, Transcutaneous

Intervention / Treatment
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* Device: Measurements of capnia and tissue oxygenation by optical transcutaneous sensors


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Interventional Model Description: One single group will have simultaneous measurements of capnia and tissue oxygenation by the new sensors and by the standard laboratory sensors
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental group<br>One single group of healthy subjects | Device: Measurements of capnia and tissue oxygenation by optical transcutaneous sensors<br>* Capnia and tissue oxygenation will be measured by optical transcutaneous sensors<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of capnia values | Comparison of capnia values measured by the new sensors and the standard laboratory sensors | Continuous measurement during the only experimental session (1 hour) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of tissue oxygenation values | Comparison of tissue oxygenation values measured by the new sensors and the standard laboratory sensors | Continuous measurement during the only experimental session (1 hour) |