Blood Gas Monitoring, TranscutaneousCTCONCT03992651
Optical Transcutaneous Sensors of Capnia and Oxygenation
A study testing Measurements of capnia and tissue oxygenation by optical transcutaneous sensors in people with Blood Gas Monitoring, Transcutaneous, run by University Hospital, Grenoble at 1 site in France.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Blood Gas Monitoring, Transcutaneous
- What is being tested?
- Measurements of capnia and tissue oxygenation by optical transcutaneous sensors
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 12 Jun 2019to 11 Oct 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 13Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
France1 site
Grenoble Alpes University Hospital
Grenoble, Auvergne-Rhône-Alpes, 38042
About this study
Official title: Validation of Optical Transcutaneous Sensors to Measure Capnia and Tissue Oxygenation
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).
- Conditions
- Blood Gas Monitoring, Transcutaneous
- Being tested
- Measurements of capnia and tissue oxygenation by optical transcutaneous sensors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measurements of capnia and tissue oxygenation by optical transcutaneous sensorsDevice
Capnia and tissue oxygenation will be measured by optical transcutaneous sensors
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | One single group of healthy subjects Receives: Device: Measurements of capnia and tissue oxygenation by optical transcutaneous sensors |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of capnia values
Comparison of capnia values measured by the new sensors and the standard laboratory sensors
Measured: Continuous measurement during the only experimental session (1 hour)
Secondary outcomes (1)
Comparison of tissue oxygenation values
Comparison of tissue oxygenation values measured by the new sensors and the standard laboratory sensors
Measured: Continuous measurement during the only experimental session (1 hour)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2019
- Study start12 Jun 2019
- Primary completion13 Jun 2019
- Study completion11 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Blood Gas Monitoring, TranscutaneousStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stéphane Doutreleau, MD PhD, Principal investigator, Grenoble Alpes Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03992651
- Sponsor's protocol ID
- EssaiClinique_CTCO
- Acronym
- CTCO
- Status last verified
- Dec 2025
- First submitted
- 17 Jun 2019
- Last updated
- 29 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Koenig A, Petitdidier N, Grateau H, Characoun S, Ghaith A, Verges S, Doutreleau S, Gharbi S, Gerbelot R, Gioux S, Dinten JM. Contact, high-resolution spatial diffuse reflectance imaging system for skin condition diagnosis: a first-in-human clinical trial. J Biomed Opt. 2021 Jan;26(1):012706. doi: 10.1117/1.JBO.26.1.012706.
PubMed 33515218
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Optical Transcutaneous Sensors to Measure Capnia and Tissue Oxygenation
- ClinicalTrials.gov ID
- NCT03992651
- Acronym / sponsor ID
- CTCO / EssaiClinique_CTCO
- Conditions
- Blood Gas Monitoring, Transcutaneous
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- 12 Jun 2019 (actual)
- Primary completion
- 13 Jun 2019 (actual)
- Study completion
- 11 Oct 2019 (actual)
- First posted
- 20 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- One single group will have simultaneous measurements of capnia and tissue oxygenation by the new sensors and by the standard laboratory sensors
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Device: Measurements of capnia and tissue oxygenation by optical transcutaneous sensorsOne single group of healthy subjects |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (13 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Measurements of capnia and tissue oxygenation by optical transcutaneous sensorsCapnia and tissue oxygenation will be measured by optical transcutaneous sensors | Device | Experimental group |
Primary outcome
Comparison of capnia values
Time frame: Continuous measurement during the only experimental session (1 hour)
Comparison of capnia values measured by the new sensors and the standard laboratory sensors
1 secondary outcome
Comparison of tissue oxygenation values
Time frame: Continuous measurement during the only experimental session (1 hour)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2025.
- Results publication: PubMed 33515218Koenig A, Petitdidier N, Grateau H, Characoun S, Ghaith A, Verges S, Doutreleau S, Gharbi S, Gerbelot R, Gioux S, Dinten JM. Contact, high-resolution spatial diffuse reflectance imaging system for skin condition diagnosis: a first-in-human clinical trial. J Biomed Opt. 2021 Jan;26(1):012706. doi: 10.1117/1.JBO.26.1.012706.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stéphane Doutreleau, MD PhD principal investigator
Grenoble Alpes Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Measurements of capnia and tissue oxygenation by optical transcutaneous sensors in people with Blood Gas Monitoring, Transcutaneous, run by University Hospital, Grenoble at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of capnia values (time frame: Continuous measurement during the only experimental session (1 hour)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03992651, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2025.