Optical Transcutaneous Sensors of Capnia and Oxygenation (CTCO)

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).

Study Overview

• Status: Completed
• Conditions: Blood Gas Monitoring, Transcutaneous
• Intervention / Treatment: Device: Measurements of capnia and tissue oxygenation by optical transcutaneous sensors

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Rhône-Alpes
    • Grenoble, Rhône-Alpes, France, 38042
      • Grenoble Alpes University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental group; One single group of healthy subjects	Device: Measurements of capnia and tissue oxygenation by optical transcutaneous sensors; Capnia and tissue oxygenation will be measured by optical transcutaneous sensors

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Collaborators and Investigators

• Sponsor: University Hospital, Grenoble
• Investigators: Principal Investigator: Stéphane Doutreleau, MD PhD, Grenoble Alpes Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 12, 2019
• Primary Completion (Actual): June 13, 2019
• Study Completion (Actual): October 11, 2019

Study Registration Dates

• First Submitted: June 17, 2019
• First Submitted That Met QC Criteria: June 19, 2019
• First Posted (Actual): June 20, 2019

Study Record Updates

• Last Update Posted (Actual): February 10, 2021
• Last Update Submitted That Met QC Criteria: February 9, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: EssaiClinique_CTCO

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No