Proof-of-concept Study on Dyspnea Analysis Via GapCO2

NCT06556797 | Recruiting

• 2 other identifiers: APHP2212512022-A01957-36
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Dyspnea; Dyspnea

Keywords

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

Outcome Measures

Primary Outcomes (1)

• GapCO2

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

  Within 1 hour after enrolment

Secondary Outcomes (2)

• Diagnostic performance of GapCO2 at 37°C

  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

  up to 28 days

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient presenting to the emergency department of the inclusion center for acute dyspea

You may qualify if:

• 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
• Non-opposition to participation in the study

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Emergency Department Hospital Avicenne

Bobigny, 93000, France

RECRUITING

MeSH Terms

Conditions

Dyspnea; Emergencies

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Disease Attributes; Pathologic Processes

Study Officials

• Judith GORLICKI, MD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Judith GORLICKI, MD

CONTACT

+33 (0)1 48 95 57 85; judith.gorlicki@aph.fr

Frédéric ADNET, MD-PhD

CONTACT

+33 (0)1 48 95 57 85; frederic.adnet@aphp.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2024
• First Posted: August 16, 2024
• Study Start: January 26, 2025
• Primary Completion: March 26, 2026
• Study Completion: April 26, 2026
• Last Updated: February 10, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)