Acute DyspneaMicroDysNCT06556797
Proof-of-concept Study on Dyspnea Analysis Via GapCO2
An observational study of Acute Dyspnea and Dyspnea, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Patients presenting to the emergency department with acute dyspnea undergo arterial blood gas measurement and monitoring of transcutaneous capnography using the TCM5 monitor. The aim of this study is to determine whether GapCO2, the difference between transcutaneous and arterial pCO2 (PaCO2 - PtcCO2), is correlated… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Dyspnea, Dyspnea
- How many people
- 45 participants
- Where
- 1 siteFrance
- Study dates
- 26 Jan 2025to 26 Apr 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient presenting to the emergency department of the inclusion center for acute dyspea
Who may be able to join
- Age ≥ 18 years
- Patient presenting with acute dyspnea defined by a sensation of respiratory discomfort with at least one of the following criteria: RR ≥ 22 and/or SpO2 < 95%
- Arterial blood gas sampling performed as part of care
- Inclusion less than 1 hour after arrival time to the emergency department
- Non-opposition to participation in the study
Who cannot join
- Temperature greater than or equal to 37.5°C
- Patient who has already received a diuretic or vasodilator treatment in the emergency department or by a prehospital medical team
- Systolic blood pressure less than or equal to 100 mmHg and/or signs of peripheral hypoperfusion
- Inability to express refusal to participate in the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Emergency Department Hospital Avicenne
Bobigny, 93000
Judith GORLICKI, +33 (0)1 48 95 57 85, judith.gorlicki@aphp.Fr
About this study
Official title: How to Differentiate Congestive and Non-congestive Dyspnea in the Emergency Department? Proof-of-concept Study on Microperfusion Analysis Via GapCO2
Patients presenting to the emergency department with acute dyspnea undergo arterial blood gas measurement and monitoring of transcutaneous capnography using the TCM5 monitor. The aim of this study is to determine whether GapCO2, the difference between transcutaneous and arterial pCO2 (PaCO2 - PtcCO2), is correlated with the congestive or non-congestive origin of dyspnea.
Read the detailed description
Upon arrival at the emergency department, patients are placed in the vital emergency reception area for monitoring. An emergency physician will review the selection criteria and offer the patient participation. The information sheet will be provided to the patient along with a copy of the non-opposition form in case of patient agreement.
Before the introduction of any treatment, a TC 92 sensor is placed on the earlobe (or on the forehead if the earlobe is inaccessible), connected to a Radiometer TCM5 monitor, measuring SpO2 (Massimo technology), perfusion index, and transcutaneous capnography (PtcCO2).
After a 5-minute equilibration period, measurements were taken throughout the duration of patient management. Standard diagnostic and therapeutic management will be provided according to the attending physician's prescription. The attending physician won't consider PtcCO2 (nor GapCO2) measurements in patient management.
At the time of data analysis, an adjudication committee comprising 2 emergency physicians from the inclusion service but not involved in patient care will review the complete medical records of patients to determine whether dyspnea was of congestive or non-congestive origin.
- Conditions
- Acute Dyspnea, Dyspnea
- Keywords
- Acute dyspnea, Emergency department, Dyspnea, Congestion, Proof-of-concept study, GapCO2
- Medical subject headings
- Dyspnea, Emergencies
What is being measured
The primary outcome is the main question the study is designed to answer.
GapCO2
PaCO2 measured via arterial blood gas analysis - PtcCO2 measured via TCM5 monitor, at 37°C
Measured: Within 1 hour after enrolment
Secondary outcomes (2)
Diagnostic performance of GapCO2 at 37°C
Measured: Within 1 hour after enrolment
Proportion of patients who underwent GapCO2 measurement among those who presented to the emergency department for dyspnea on the days of inclusion
Feasibility of measuring GapCO2 in the emergency department
Measured: up to 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2024
- Study start26 Jan 2025
- Primary completion26 Mar 2026 (estimated)
- Study completion26 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute DyspneaStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Judith GORLICKI, MD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06556797
- Sponsor's protocol ID
- APHP221251
- Other IDs
- 2022-A01957-36
- Acronym
- MicroDys
- Status last verified
- Feb 2026
- First submitted
- 21 Jun 2024
- Last updated
- 10 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- How to Differentiate Congestive and Non-congestive Dyspnea in the Emergency Department? Proof-of-concept Study on Microperfusion Analysis Via GapCO2
- ClinicalTrials.gov ID
- NCT06556797
- Acronym / sponsor ID
- MicroDys / APHP221251
- Conditions
- Acute Dyspnea, Dyspnea
- Keywords
- Acute dyspnea, Emergency department, Dyspnea, Congestion, Proof-of-concept study, GapCO2
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 26 Jan 2025 (actual)
- Primary completion
- 26 Mar 2026 (estimated)
- Study completion
- 26 Apr 2026 (estimated)
- First posted
- 16 Aug 2024 (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.
Patients presenting to the emergency department with acute dyspnea undergo arterial blood gas measurement and monitoring of transcutaneous capnography using the TCM5 monitor. The aim of this study is to determine whether GapCO2, the difference between transcutaneous and arterial pCO2 (PaCO2 - PtcCO2), is correlated with the congestive or non-congestive origin of dyspnea.
Detailed description
Upon arrival at the emergency department, patients are placed in the vital emergency reception area for monitoring. An emergency physician will review the selection criteria and offer the patient participation. The information sheet will be provided to the patient along with a copy of the non-opposition form in case of patient agreement.
Before the introduction of any treatment, a TC 92 sensor is placed on the earlobe (or on the forehead if the earlobe is inaccessible), connected to a Radiometer TCM5 monitor, measuring SpO2 (Massimo technology), perfusion index, and transcutaneous capnography (PtcCO2).
After a 5-minute equilibration period, measurements were taken throughout the duration of patient management. Standard diagnostic and therapeutic management will be provided according to the attending physician's prescription. The attending physician won't consider PtcCO2 (nor GapCO2) measurements in patient management.
At the time of data analysis, an adjudication committee comprising 2 emergency physicians from the inclusion service but not involved in patient care will review the complete medical records of patients to determine whether dyspnea was of congestive or non-congestive origin.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient presenting to the emergency department of the inclusion center for acute dyspea
Key inclusion criteria (5 listed)
- Age ≥ 18 years
- Patient presenting with acute dyspnea defined by a sensation of respiratory discomfort with at least one of the following criteria: RR ≥ 22 and/or SpO2 < 95%
- Arterial blood gas sampling performed as part of care
- Inclusion less than 1 hour after arrival time to the emergency department
- Non-opposition to participation in the study
Key exclusion criteria (4 listed)
- Temperature greater than or equal to 37.5°C
- Patient who has already received a diuretic or vasodilator treatment in the emergency department or by a prehospital medical team
- Systolic blood pressure less than or equal to 100 mmHg and/or signs of peripheral hypoperfusion
- Inability to express refusal to participate in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
GapCO2
Time frame: Within 1 hour after enrolment
PaCO2 measured via arterial blood gas analysis - PtcCO2 measured via TCM5 monitor, at 37°C
2 secondary outcomes
Diagnostic performance of GapCO2 at 37°C
Time frame: Within 1 hour after enrolment
Proportion of patients who underwent GapCO2 measurement among those who presented to the emergency department for dyspnea on the days of inclusion
Time frame: up to 28 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2026.
- Individual participant dataSharing planned: No
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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.
Judith GORLICKI, MD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Dyspnea and Dyspnea, run by Assistance Publique - Hôpitaux de Paris 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 5 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: looking for participants now, as of the sponsor's last update on 10 Feb 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Judith GORLICKI, MD (+33 (0)1 48 95 57 85, judith.gorlicki@aph.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
GapCO2 (time frame: Within 1 hour after enrolment). 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 10 Feb 2026; AzTrials last refreshed its copy on 4 Nov 2026.