Skip to content

Proof-of-concept Study on Dyspnea Analysis Via GapCO2

How to Differentiate Congestive and Non-congestive Dyspnea in the Emergency Department? Proof-of-concept Study on Microperfusion Analysis Via GapCO2

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06556797
Acronym
MicroDys
Enrollment
45
Registered
2024-08-16
Start date
2025-01-26
Completion date
2026-04-26
Last updated
2026-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Dyspnea, Dyspnea

Keywords

Acute dyspnea, Emergency department, Dyspnea, Congestion, Proof-of-concept study, GapCO2

Brief 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 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.

Interventions

None listed

Sponsors

Assistance Publique - Hôpitaux de Paris
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
GapCO2Within 1 hour after enrolmentPaCO2 measured via arterial blood gas analysis - PtcCO2 measured via TCM5 monitor, at 37°C

Secondary

MeasureTime frameDescription
Diagnostic performance of GapCO2 at 37°CWithin 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 inclusionup to 28 daysFeasibility of measuring GapCO2 in the emergency department

Countries

France

Contacts

CONTACTJudith GORLICKI, MD
judith.gorlicki@aph.fr+33 (0)1 48 95 57 85
CONTACTFrédéric ADNET, MD-PhD
frederic.adnet@aphp.fr+33 (0)1 48 95 57 85
PRINCIPAL_INVESTIGATORJudith GORLICKI, MD

Assistance Publique - Hôpitaux de Paris

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 11, 2026