Proof-of-concept Study on Dyspnea Analysis Via GapCO2

NCT ID: NCT06556797

Last Updated: 2026-02-10

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 45 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-01-26
• Study Completion Date: 2026-04-26

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.

Conditions

Acute Dyspnea; Dyspnea

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Judith GORLICKI, MD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

Emergency Department Hospital Avicenne

Bobigny, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Judith GORLICKI, MD

Role: CONTACT

judith.gorlicki@aph.fr

+33 (0)1 48 95 57 85

Frédéric ADNET, MD-PhD

Role: CONTACT

frederic.adnet@aphp.fr

+33 (0)1 48 95 57 85

Facility Contacts

Judith GORLICKI

Role: primary

judith.gorlicki@aphp.Fr

+33 (0)1 48 95 57 85

Other Identifiers

2022-A01957-36

Identifier Type: OTHER

Identifier Source: secondary_id

APHP221251

Identifier Type: -

Identifier Source: org_study_id