NCT05637138

Brief Summary

The measurement of tcpCO2 has many disadvantages: the need for regular calibration (4 to 8 hours) of the sensor, the fact that the sensor heats the skin (risk of burns), the impossibility of measurement in ambulatory and the high cost of the monitor. In order to develop a new type of tcpCO2 sensor, it is necessary to acquire knowledge in fundamental physiology on the diffusion of CO2 through the skin.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 24, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 5, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

January 23, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 23, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 23, 2023

Completed
Last Updated

January 31, 2023

Status Verified

January 1, 2023

Enrollment Period

7 months

First QC Date

November 24, 2022

Last Update Submit

January 30, 2023

Conditions

Healthy Volunteers, Pathologies for Which paCO2 Monitoring is Crucial, Particularly in the Context of Chronic Obstructive Pulmonary Disease (COPD)

Outcome Measures

Primary Outcomes (1)

  • CO2 diffusion through skin

    Measurement of the conductivity of tissues in CO2: Ks variable, by CAPNOS probe in 5 measures: Non-thermostated, 35, 38, 41 and 44°C

    Day 0

Secondary Outcomes (2)

  • Measurement of the subcutaneous microcirculation

    Day 0

  • Measurement of TcpO2

    Day 0

Study Arms (1)

Healthy volunteer

OTHER

The totality of the measurements will be carried out on a single visit following the obtaining of the consent (obtained the same day or during a preceding visit). The total duration of this single visit, including the time of information, the collection of consent and all the measurements is estimated at 2 hours per subject. Before the installation of the different measuring devices, a preliminary interview and a clinical examination will be carried out in order to verify in particular the absence of skin lesions. The measurement of subcutaneous microcirculation (no unit) and tcpO2 (kPa) will be carried out simultaneously with the measurement of CO2 diffusion (main criterion), during a single session of measurements at 5 different temperatures (non-thermostated, then thermostated at 35, 38, 41 and 44°C)

Device: tcpCO2 measureDevice: tcpO2 measureDevice: measurement of tissue conductivity to CO2: KSDevice: measurement of microcirculation

Interventions

tcpCO2 measureDEVICE

Measurement of tcpCO2 by medical grade sensor: non-thermostatted, at 35°C, 38°C, 41°C and 44°C

Healthy volunteer
tcpO2 measureDEVICE

Measurement of tcpO2 by medical grade sensor: non-thermostatted, at 35°C, 38°C, 41°C and 44°C

Healthy volunteer
measurement of tissue conductivity to CO2: KSDEVICE

measurement of tissue conductivity to CO2: KS by CAPNOS sensor : non-thermostatted, at 35°C, 38°C, 41°C and 44°C

Healthy volunteer
measurement of microcirculationDEVICE

measurement of microcirculation by CAPNOS sensor : non-thermostatted, at 35°C, 38°C, 41°C and 44°C

Healthy volunteer

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Men or women over 18 and under 80 years of age
  • Do not present any contraindication (e.g. skin lesions such as eczema, psoriasis,...) to any of the investigations of the study
  • Have given their free, informed and written consent

You may not qualify if:

  • Subjects under 18 or over 80 years of age
  • Skin lesion at any of the measurement sites
  • Inability to give written informed consent
  • Subjects taking vasodilator treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Giroux Metges

Brest, 29200, France

RECRUITING

Central Study Contacts

Marie-Agnes GIROUX-METGES, PU-PH

CONTACT

02 98 34 73 66marie-agnes.metges@chu-brest.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
Open label
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Model Details: only one group of healthy volunteers is planned in the study, for which measurements of skin permeability, subcutaneous microcirculation and TcpO2 / oxygen sensor will be performed.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 24, 2022

First Posted

December 5, 2022

Study Start

January 23, 2023

Primary Completion

August 23, 2023

Study Completion

August 23, 2023

Last Updated

January 31, 2023

Record last verified: 2023-01

Locations

FR(1)