Optical Transcutaneous Sensors of Capnia and Oxygenation

Not Applicable

Completed

• Conditions: Blood Gas Monitoring, Transcutaneous
• Interventions: Device: Measurements of capnia and tissue oxygenation by optical transcutaneous sensors

• Registration Number: NCT03992651
• Lead Sponsor: University Hospital, Grenoble

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2019-06-12
• Primary Completion: 2019-06-13
• Study First Submitted: 2019-06-17
• Study First Submitted QC: 2019-06-19
• Study First Posted: 2019-06-20
• Study Completion: 2019-10-11
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-09
• Last Update Posted: 2021-02-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Experimental group	Measurements of capnia and tissue oxygenation by optical transcutaneous sensors	One single group of healthy subjects

Primary Outcome Measures

Name	Time	Method
Comparison of capnia values	Continuous measurement during the only experimental session (1 hour)	Comparison of capnia values measured by the new sensors and the standard laboratory sensors

Secondary Outcome Measures

Name	Time	Method
Comparison of tissue oxygenation values	Continuous measurement during the only experimental session (1 hour)	Comparison of tissue oxygenation values measured by the new sensors and the standard laboratory sensors

Trial Locations

Locations (1)

Grenoble Alpes University Hospital; 🇫🇷 Grenoble, Rhône-Alpes, France