PAthwAy of Dyspneic patIent in Emergency in France (Fr-PArADIse)

This observational retrospective multi-center study focuses on patients treated for acute dyspnea by emergency medical teams. The primary objective is to identify factors associated with the risk of mortality and rehospitalization in these patients. This evaluation will be conducted both overall and within specific subgroups of interest, including gender (men/women), age categories, mode of admission, and comorbidities.

Study Overview

• Status: Not yet recruiting
• Conditions: Acute Dyspnea

• Study Type: Observational
• Enrollment (Estimated): 89700

Contacts and Locations

• Study Contact: Name: Nicolas GIRERD, MD, PhD; Phone Number: +33383157322; Email: n.girerd@chru-nancy.fr
• Study Contact Backup: Name: Tahar CHOUIHED, MD, PhD; Phone Number: +33383157322; Email: t.chouihed@chru-nancy.fr

Study Locations

• France
  • Besançon, France
    • CHU de Besancon
    • Contact: Omide TAHERI
    • Principal Investigator: Omide TAHERI, MD
    • Principal Investigator: Johan COSSUS, MD
  • Dijon, France
    • CHU de DIJON
    • Contact: Patrick RAY, MD, PhD
    • Principal Investigator: Patrick RAY, MD, PhD
  • Lyon, France
    • Hospices civils de Lyon, Groupement Hospitalier Édouard-Herriot
    • Principal Investigator: Karim TAZAROURTE, MD, PhD
    • Contact: Stephanie BOSNE, MD
    • Principal Investigator: Stéphanie BOSNE, MD
  • Nancy, France
    • CHRU of Nancy
    • Principal Investigator: Nicolas GIRERD, MD, PhD
    • Contact: Tahar CHOUIHED; Phone Number: +33383157322; Email: t.chouihed@chru-nancy.fr
    • Contact: Nicolas GIRERD; Phone Number: 0383157322; Email: n.girerd@chru-nancy.fr
    • Principal Investigator: Tahar CHOUIHED, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adult patients treated in the emergency department for acute dyspnea.

Description

Inclusion Criteria:

• Man or women aged 18 years and older.
• Patients with acute dyspnea managed by a medical emergency team at the investigator centers between 2010 and 2021.

Exclusion Criteria:

- Cardiorespiratory arrest before emergency department management.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All-cause post-hospitalization mortality and rehospitalization	Composite endpoint of all-cause post-hospitalization mortality and rehospitalization	Within 5 years following hospital discharge

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of readmissions (all-cause and specific - including hospitalization for acute dyspnea ).		1 month and 1 year post admission for acute dyspnea in the emergency department
Post admission mortality	Assessed by: Composite criterion of rehospitalization and/or death following emergency department admission (short and long-term). with outcome 5.	Within 20 years following hospital discharge
Post admission rehospitalization	Assessed by: Composite criterion of rehospitalization and/or death following emergency department admission (short and long-term) with outcome with outcome 4.	Within 20 years following hospital discharge
Erroneous etiological diagnosis of dyspnea in the emergency department	Assessed by: defined as a discrepancy between the diagnosis at discharge from the emergency department and the final diagnosis in the hospital discharge letter	Within hospital stay, maximum 21 days
All-cause mortality and specific mortality (cardiovascular and non-cardiovascular).	Assessed by: Composite endpoint of all-cause mortality and specific mortality (cardiovascular and non-cardiovascular) with outcome 8	Within 5 years following hospital discharge
Emergency post-admission mortality	Assessed by: Composite criterion of mortality and rehospitalization post-admission for acute dyspnea in the emergency department over the long term with outcome 9	Within 20 years following hospital discharge
Emergency post-admission rehospitalisation	Assessed by: Composite criterion of mortality and rehospitalization post-admission for acute dyspnea in the emergency department over the long term outcome 8	Within 20 years following hospital discharge
Duration of stay in the emergency department	Assessed by: Duration of stay in the emergency department	Within hospital stay, maximum 21 days
Erroneous etiological diagnosis of dyspnea in the emergency department	Assessed by: Erroneous etiological diagnosis of dyspnea in the emergency department	Within hospital stay, maximum 21 days
In-hospital mortality	Assessed by: In-hospital mortality	Within hospital stay, maximum 21 days
Length of hospital stay	Assessed by: Length of hospital stay	Within hospital stay, maximum 21 days
Post emergency admission (For dyspnea) mortality and rehospitalization	Assessed by: Post emergency admission (For dyspnea) mortality and rehospitalization	Within 5 years following hospital discharge

Collaborators and Investigators

• Sponsor: Pr. Nicolas GIRERD
• Investigators: Principal Investigator: Tahar CHOUIHED, MD, PhD, Central Hospital, Nancy, France; Principal Investigator: Nicolas GIRERD, MD, PhD, CHRU de NANCY

Study record dates

Study Major Dates

• Study Start (Estimated): September 30, 2024
• Primary Completion (Estimated): September 30, 2025
• Study Completion (Estimated): September 30, 2031

Study Registration Dates

• First Submitted: July 4, 2024
• First Submitted That Met QC Criteria: July 18, 2024
• First Posted (Actual): July 19, 2024

Study Record Updates

• Last Update Posted (Actual): July 22, 2024
• Last Update Submitted That Met QC Criteria: July 18, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Dyspnea
• Other Study ID Numbers: 2022PI21

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No