Optical Transcutaneous Sensors of Capnia and Oxygenation

NCT ID: NCT03992651

Last Updated: 2025-12-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-12

Study Completion Date

2019-10-11

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).

Detailed Description

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Conditions

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Blood Gas Monitoring, Transcutaneous

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

One single group will have simultaneous measurements of capnia and tissue oxygenation by the new sensors and by the standard laboratory sensors
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Experimental group

One single group of healthy subjects

Group Type EXPERIMENTAL

Measurements of capnia and tissue oxygenation by optical transcutaneous sensors

Intervention Type DEVICE

Capnia and tissue oxygenation will be measured by optical transcutaneous sensors

Interventions

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Measurements of capnia and tissue oxygenation by optical transcutaneous sensors

Capnia and tissue oxygenation will be measured by optical transcutaneous sensors

Intervention Type DEVICE

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital, Grenoble

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Stéphane Doutreleau, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Grenoble Alpes Hospital

Locations

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Grenoble Alpes University Hospital

Grenoble, Auvergne-Rhône-Alpes, France

Site Status

Countries

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France

References

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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.

Reference Type RESULT
PMID: 33515218 (View on PubMed)

Other Identifiers

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EssaiClinique_CTCO

Identifier Type: -

Identifier Source: org_study_id