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Healthy Volunteers, Pathologies for Which paCO2 Monitoring is Crucial, Particularly in the Context of Chronic Obstructive Pulmonary Disease (COPD)CAPNOSNCT05637138

Influence of Temperature on Transcutaneous Blood Gas Diffusion: CAPNOS Project

A study testing tcpCO2 measure, tcpO2 measure and measurement of tissue conductivity to CO2: KS in people with Healthy Volunteers, Pathologies for Which paCO2 Monitoring is Crucial, Particularly in the Context of Chronic Obstructive Pulmonary Disease (COPD), run by University Hospital, Brest at 1 site in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 yearsHealthy volunteers can take part
What is being tested?
tcpCO2 measure, tcpO2 measure and measurement of tissue conductivity to CO2: KS
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteFrance
Study dates
23 Jan 2023to 23 Aug 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Marie-Agnes GIROUX-METGES, PU-PH contact

02 98 34 73 66

marie-agnes.metges@chu-brest.fr

France1 site, 1 recruiting
  • Giroux Metges

    Brest, 29200

    Marie-Agnès Giroux Metges, marie-agnes.metges@univ-brest.fr

    Recruiting

Other trials in France

About this study

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.

Read the detailed description

From a clinical point of view, the arterial carbon dioxide (CO2) pressure - paCO2 - is a particularly interesting physiological data because it gives information on the proper functioning of the cardiorespiratory system. However, the current "gold standard" measurement of this paCO2 requires an arterial puncture, an operation that requires qualified personnel, a rapid analysis of the blood samples collected, and entails risks and discomfort for the patient. In fact, the transcutaneous partial pressure of CO2 - tcpCO2 - is often used as an indirect measure for paCO2, due to its good correlation with the latter. However, current tcpCO2 monitors are bulky, expensive (€10-20k), and possess significant drift resulting in the need to recalibrate the measurement electrode every 4-8 hours. Moreover, these monitors heat the skin to temperatures between 41 and 44°C which can lead to burns, especially when used on infants.

Indeed, an alternative to current tcpCO2 monitors seems highly desirable. In particular, in the face of the rise of wearable electronics, a solution approaching wrist-worn pulse oximeters but for CO2 measurement would be an undeniable asset that cannot be achieved without an overhaul of the tcpCO2 measurement technology.

It is in this global context that the present research is set; to develop a portable tcpCO2 sensor, two main avenues are to be explored. On the one hand, it is necessary to know the modalities of CO2 diffusion through the subcutaneous tissues and the skin towards an external medium (ambient air or sensor). On the other hand, it is necessary to develop a reliable technique to measure CO2 by means of a sensor placed against the skin and this with a minimal drift.

The present research focuses exclusively on the first of these two tracks, i.e. on the phenomenon of CO2 diffusion through the skin. Indeed, the literature on this subject is old and incomplete. In particular, the diffusion rate of CO2 through the skin as a function of skin temperature is not known. However, this variation is of crucial interest for the dimensioning of a tcpCO2 sensor in terms of autonomy. Indeed, the CO2 diffusion rate through the skin has a direct influence on the response time of such a sensor.

The present research is therefore purely exploratory, with the objective of acquiring new knowledge in physiology. It aims to fill the gaps in the literature on the variations of transcutaneous CO2 diffusion rate as a function of temperature, with the long-term objective of developing a new type of tcpCO2 sensor circumventing the constraints of current monitors. The aim is not to develop a new type of tcpCO2 sensor, but to characterize the diffusion rate of CO2 through the skin using a system developed specifically for this study. The measurement system used is an experimental device not intended to be marketed as a medical device. Indeed, it measures a CO2 flow rate and not a partial pressure - partial pressure which is, as a reminder, the quantity of clinical interest.

Being tested
tcpCO2 measure, tcpO2 measure, measurement of tissue conductivity to CO2: KS, measurement of microcirculation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • tcpCO2 measureDevice

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

  • tcpO2 measureDevice

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

  • 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

  • measurement of microcirculationDevice

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

Study groups in NCT05637138
Study groupRoleWhat they receive
Healthy volunteerOtherThe 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)
Receives: Device: tcpCO2 measure; Device: tcpO2 measure; Device: measurement of tissue conductivity to CO2: KS; Device: measurement of microcirculation

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: Day 0

Secondary outcomes (2)
  1. Measurement of the subcutaneous microcirculation

    Measurement of subcutaneous microcirculation (without unit) at Non-thermostated, 35°C, 38°C, 41°C and 44°C by laser Doppler probe

    Measured: Day 0

  2. Measurement of TcpO2

    TcpO2 measurement (kPa) at Non-thermostated, 35°C, 38°C, 41°C and 44°C by oxygen sensor

    Measured: Day 0

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Dec 2022
  2. Study start23 Jan 2023
  3. Primary completion23 Aug 2023 (estimated)
  4. Study completion23 Aug 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Model description
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.
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05637138
Sponsor's protocol ID
29BRC22.0188
Acronym
CAPNOS
Status last verified
Jan 2023
First submitted
24 Nov 2022
Last updated
31 Jan 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing tcpCO2 measure, tcpO2 measure and measurement of tissue conductivity to CO2: KS in people with Healthy Volunteers, Pathologies for Which paCO2 Monitoring is Crucial, Particularly in the Context of Chronic Obstructive Pulmonary Disease (COPD), run by University Hospital, Brest at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 31 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Marie-Agnes GIROUX-METGES, PU-PH (02 98 34 73 66, marie-agnes.metges@chu-brest.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

CO2 diffusion through skin (time frame: Day 0). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2023.

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