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 range

18 Years – 50 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Comparison of capnia values

Timeframe: Continuous measurement during the only experimental session (1 hour)

Trial details

NCT IDNCT03992651

SponsorUniversity Hospital, Grenoble

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-06-13

View on ClinicalTrials.gov More Blood Gas Monitoring, Transcutaneous trials

Who can participate

Age range

18 Years – 50 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.