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.
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
- Conditions the study is for
- Healthy Volunteers, Pathologies for Which paCO2 Monitoring is Crucial, Particularly in the Context of Chronic Obstructive Pulmonary Disease (COPD)
- What is being tested?
- tcpCO2 measure, tcpO2 measure and measurement of tissue conductivity to CO2: KS
- Type of treatment
- Injection or infusion, Medical device
- 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.
France1 site, 1 recruiting
- Recruiting
Giroux Metges
Brest, 29200
Marie-Agnès Giroux Metges, marie-agnes.metges@univ-brest.fr
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 group | Role | What they receive |
|---|---|---|
| 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) 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.
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)
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
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.
- First posted5 Dec 2022
- Study start23 Jan 2023
- Primary completion23 Aug 2023 (estimated)
- Study completion23 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Volunteers, Pathologies for Which paCO2 Monitoring is Crucial, Particularly in the Context of Chronic Obstructive Pulmonary Disease (COPD)Studies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
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
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Temperature on Transcutaneous Blood Gas Diffusion: CAPNOS Project
- ClinicalTrials.gov ID
- NCT05637138
- Acronym / sponsor ID
- CAPNOS / 29BRC22.0188
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 23 Jan 2023 (actual)
- Primary completion
- 23 Aug 2023 (estimated)
- Study completion
- 23 Aug 2023 (estimated)
- First posted
- 5 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Healthy volunteer | Other | Device: tcpCO2 measure, Device: tcpO2 measure, Device: measurement of tissue conductivity to CO2: KS, Device: measurement of microcirculationThe 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) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tcpCO2 measureMeasurement of tcpCO2 by medical grade sensor: non-thermostatted, at 35°C, 38°C, 41°C and 44°C | Device | Healthy volunteer |
| tcpO2 measureMeasurement of tcpO2 by medical grade sensor: non-thermostatted, at 35°C, 38°C, 41°C and 44°C | Device | Healthy volunteer |
| measurement of tissue conductivity to CO2: KSmeasurement of tissue conductivity to CO2: KS by CAPNOS sensor : non-thermostatted, at 35°C, 38°C, 41°C and 44°C | Device | Healthy volunteer |
| measurement of microcirculationmeasurement of microcirculation by CAPNOS sensor : non-thermostatted, at 35°C, 38°C, 41°C and 44°C | Device | Healthy volunteer |
Primary outcome
CO2 diffusion through skin
Time frame: Day 0
Measurement of the conductivity of tissues in CO2: Ks variable, by CAPNOS probe in 5 measures: Non-thermostated, 35, 38, 41 and 44°C
2 secondary outcomes
Measurement of the subcutaneous microcirculation
Time frame: Day 0
Measurement of TcpO2
Time frame: Day 0
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2023.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
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.