CTCO: Optical Transcutaneous Sensors of Capnia and Oxygenation

Sponsor

University Hospital, Grenoble (Other)

Overall Status

Completed

CT.gov ID

NCT03992651

Collaborator

(none)

Enrollment

Location

Arm

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Blood Gas Monitoring, Transcutaneous	Device: Measurements of capnia and tissue oxygenation by optical transcutaneous sensors	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

20 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

One single group will have simultaneous measurements of capnia and tissue oxygenation by the new sensors and by the standard laboratory sensorsOne single group will have simultaneous measurements of capnia and tissue oxygenation by the new sensors and by the standard laboratory sensors

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

Validation of Optical Transcutaneous Sensors to Measure Capnia and Tissue Oxygenation

Actual Study Start Date :

Jun 12, 2019

Actual Primary Completion Date :

Jun 13, 2019

Actual Study Completion Date :

Oct 11, 2019

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Grenoble Alpes University Hospital	Grenoble	Rhône-Alpes	France	38042

Sponsors and Collaborators

University Hospital, Grenoble

Investigators

Principal Investigator: Stéphane Doutreleau, MD PhD, Grenoble Alpes Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University Hospital, Grenoble

ClinicalTrials.gov Identifier:

NCT03992651

Other Study ID Numbers:

EssaiClinique_CTCO

First Posted:

Jun 20, 2019

Last Update Posted:

Feb 10, 2021

Last Verified:

Feb 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Feb 10, 2021