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

July 18, 2024 updated by: Pr. Nicolas GIRERD
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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
89700

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • France
      • Besançon, France
        • CHU de Besançon
        • 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:
        • Contact:
        • Principal Investigator:
          • Tahar CHOUIHED, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
All-cause post-hospitalization mortality and rehospitalization
Time Frame: Within 5 years following hospital discharge
Composite endpoint of all-cause post-hospitalization mortality and rehospitalization
Within 5 years following hospital discharge

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Proportion of readmissions (all-cause and specific - including hospitalization for acute dyspnea ).
Time Frame: 1 month and 1 year post admission for acute dyspnea in the emergency department
1 month and 1 year post admission for acute dyspnea in the emergency department
Post admission mortality
Time Frame: Within 20 years following hospital discharge
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
Time Frame: Within 20 years following hospital discharge
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
Time Frame: Within hospital stay, maximum 21 days
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).
Time Frame: Within 5 years following hospital discharge
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
Time Frame: Within 20 years following hospital discharge
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
Time Frame: Within 20 years following hospital discharge
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
Time Frame: Within hospital stay, maximum 21 days
Assessed by: Duration of stay in the emergency department
Within hospital stay, maximum 21 days
Erroneous etiological diagnosis of dyspnea in the emergency department
Time Frame: Within hospital stay, maximum 21 days
Assessed by: Erroneous etiological diagnosis of dyspnea in the emergency department
Within hospital stay, maximum 21 days
In-hospital mortality
Time Frame: Within hospital stay, maximum 21 days
Assessed by: In-hospital mortality
Within hospital stay, maximum 21 days
Length of hospital stay
Time Frame: Within hospital stay, maximum 21 days
Assessed by: Length of hospital stay
Within hospital stay, maximum 21 days
Post emergency admission (For dyspnea) mortality and rehospitalization
Time Frame: Within 5 years following hospital discharge
Assessed by: Post emergency admission (For dyspnea) mortality and rehospitalization
Within 5 years following hospital discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Pr. Nicolas GIRERD

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Tahar CHOUIHED, MD, PhD, Central Hospital, Nancy, France
  • Principal Investigator: Nicolas GIRERD, MD, PhD, CHRU de Nancy

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 30, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 30, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 30, 2031

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 4, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 18, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 19, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 22, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 18, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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