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Optical Transcutaneous Sensors of Capnia and Oxygenation (CTCO)

Grenoble Alpes University Hospital Center (CHU) logo

Grenoble Alpes University Hospital Center (CHU)

Status

Completed

Conditions

Blood Gas Monitoring, Transcutaneous

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT03992651
EssaiClinique_CTCO

Details and patient eligibility

About

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).

Enrollment

20 patients

Sex

All

Ages

18 to 50 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

20 participants in 1 patient group

Experimental group
Experimental group
Description:
One single group of healthy subjects
Treatment:
Device: Measurements of capnia and tissue oxygenation by optical transcutaneous sensors

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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