Optical Transcutaneous Sensors of Capnia and Oxygenation

NCT03992651 | Completed

• 1 other identifier: EssaiClinique_CTCO
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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).

Conditions

Blood Gas Monitoring, Transcutaneous

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Comparison of tissue oxygenation values

  Continuous measurement during the only experimental session (1 hour)

Study Arms (1)

Experimental group

EXPERIMENTAL

One single group of healthy subjects

Device: Measurements of capnia and tissue oxygenation by optical transcutaneous sensors

Interventions

Measurements of capnia and tissue oxygenation by optical transcutaneous sensors DEVICE

Capnia and tissue oxygenation will be measured by optical transcutaneous sensors

Experimental group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Grenoble: lead

Study Sites (1)

Grenoble Alpes University Hospital

Grenoble, Auvergne-Rhône-Alpes, 38042, France

Location

Related Publications (1)

• 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.

  PMID: 33515218 RESULT

Study Officials

• Stéphane Doutreleau, MD PhD

  Grenoble Alpes Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: One single group will have simultaneous measurements of capnia and tissue oxygenation by the new sensors and by the standard laboratory sensors

Study Record Dates

• First Submitted: June 17, 2019
• First Posted: June 20, 2019
• Study Start: June 12, 2019
• Primary Completion: June 13, 2019
• Study Completion: October 11, 2019
• Last Updated: December 29, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)