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Recruiting

NCT Number: NCT06556797

Proof-of-concept Study on Dyspnea 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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. GapCO2

    Time frame: Within 1 hour after enrolment

    PaCO2 measured via arterial blood gas analysis - PtcCO2 measured via TCM5 monitor, at 37°C

Secondary outcomes

  1. Diagnostic performance of GapCO2 at 37°C

    Time frame: Within 1 hour after enrolment

  2. 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

    Feasibility of measuring GapCO2 in the emergency department

Study contacts

Contact information is provided by the study sponsor or research team.

Frédéric ADNET, MD-PhD

CONTACT

[email protected]

+33 (0)1 48 95 57 85

Judith GORLICKI, MD

CONTACT

[email protected]

+33 (0)1 48 95 57 85

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

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

Acronym: MicroDys

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 16, 2024
Registry last updated
Feb 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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