Blood Gas Monitoring, Transcutaneous
Conditions
Brief 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).
Interventions
DEVICEMeasurements of capnia and tissue oxygenation by optical transcutaneous sensors
Capnia and tissue oxygenation will be measured by optical transcutaneous sensors
Sponsors
University Hospital, Grenoble
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
One single group will have simultaneous measurements of capnia and tissue oxygenation by the new sensors and by the standard laboratory sensors
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of capnia values | Continuous measurement during the only experimental session (1 hour) | Comparison of capnia values measured by the new sensors and the standard laboratory sensors |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of tissue oxygenation values | Continuous measurement during the only experimental session (1 hour) | Comparison of tissue oxygenation values measured by the new sensors and the standard laboratory sensors |
Countries
France
Outcome results
None listed