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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03992651
Other study ID # EssaiClinique_CTCO
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 12, 2019
Est. completion date October 11, 2019

Study information

Verified date February 2021
Source University Hospital, Grenoble
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date October 11, 2019
Est. primary completion date June 13, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 50 Years
Eligibility 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


Related Conditions & MeSH terms

  • Blood Gas Monitoring, Transcutaneous

Intervention

Device:
Measurements of capnia and tissue oxygenation by optical transcutaneous sensors
Capnia and tissue oxygenation will be measured by optical transcutaneous sensors

Locations

Country Name City State
France Grenoble Alpes University Hospital Grenoble Rhône-Alpes

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Grenoble

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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)
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