Blood Gas Monitoring, Transcutaneous Clinical Trial
— CTCOOfficial title:
Validation of Optical Transcutaneous Sensors to Measure Capnia and Tissue Oxygenation
Verified date | February 2021 |
Source | University Hospital, Grenoble |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Completed |
Enrollment | 20 |
Est. completion date | October 11, 2019 |
Est. primary completion date | June 13, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 50 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
France | Grenoble Alpes University Hospital | Grenoble | Rhône-Alpes |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Grenoble |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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) |
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