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Completed

NCT Number: NCT03992651

Optical Transcutaneous Sensors of Capnia and 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).

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Key information

Conditions

Blood Gas Monitoring, Transcutaneous

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Grenoble Alpes University Hospital

Grenoble, Auvergne-Rhône-Alpes, 38042, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Measurements of capnia and tissue oxygenation by optical transcutaneous sensors

Device

Capnia and tissue oxygenation will be measured by optical transcutaneous sensors

Primary outcomes

  1. Comparison of capnia values

    Time frame: Continuous measurement during the only experimental session (1 hour)

    Comparison of capnia values measured by the new sensors and the standard laboratory sensors

Secondary outcomes

  1. Comparison of tissue oxygenation values

    Time frame: Continuous measurement during the only experimental session (1 hour)

    Comparison of tissue oxygenation values measured by the new sensors and the standard laboratory sensors

Sponsors and collaborators

Lead sponsor

University Hospital, Grenoble

Other

Registry information

Official study title

Validation of Optical Transcutaneous Sensors to Measure Capnia and Tissue Oxygenation

Acronym: CTCO

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jun 20, 2019
Registry last updated
Dec 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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