Acute DyspneaFr-PArADIseNCT06509854
PAthwAy of Dyspneic patIent in Emergency in France
An observational study of Acute Dyspnea, run by Pr. Nicolas GIRERD at 4 sites in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Dyspnea
- How many people
- 89,700 participants
- Where
- 4 sitesFrance
- Study dates
- 30 Sep 2024to 30 Sep 2031
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients treated in the emergency department for acute dyspnea.
Who may be able to join
- 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.
Who cannot join
- Cardiorespiratory arrest before emergency department management.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France4 sites
CHU de Besançon
Besançon
Omide TAHERI
Omide TAHERI, MD
CHU de Dijon
Dijon
Patrick RAY, MD, PhD
Patrick RAY, MD, PhD
Hospices civils de Lyon, Groupement Hospitalier Édouard-Herriot
Lyon
Stephanie BOSNE, MD
Stéphanie BOSNE, MD
CHRU of Nancy
Nancy
Tahar CHOUIHED, +33383157322, t.chouihed@chru-nancy.fr
Nicolas GIRERD, 0383157322, n.girerd@chru-nancy.fr
About this study
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.
- Conditions
- Acute Dyspnea
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause post-hospitalization mortality and rehospitalization
Composite endpoint of all-cause post-hospitalization mortality and rehospitalization
Measured: Within 5 years following hospital discharge
Secondary outcomes (12)
Proportion of readmissions (all-cause and specific - including hospitalization for acute dyspnea ).
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Within 20 years following hospital discharge
Duration of stay in the emergency department
Assessed by: Duration of stay in the emergency department
Measured: 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
Measured: Within hospital stay, maximum 21 days
In-hospital mortality
Assessed by: In-hospital mortality
Measured: Within hospital stay, maximum 21 days
Length of hospital stay
Assessed by: Length of hospital stay
Measured: Within hospital stay, maximum 21 days
Post emergency admission (For dyspnea) mortality and rehospitalization
Assessed by: Post emergency admission (For dyspnea) mortality and rehospitalization
Measured: Within 5 years following hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2024
- Study start30 Sep 2024 (estimated)
- Primary completion30 Sep 2025 (estimated)
- Study completion30 Sep 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute DyspneaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 89,700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pr. Nicolas GIRERD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Pr. Nicolas GIRERD, Central Hospital, Nancy, France
- Investigators
- Tahar CHOUIHED, MD, PhD, Principal investigator, Central Hospital, Nancy, FranceNicolas GIRERD, MD, PhD, Principal investigator, CHRU de Nancy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06509854
- Sponsor's protocol ID
- 2022PI21
- Acronym
- Fr-PArADIse
- Status last verified
- Jul 2024
- First submitted
- 4 Jul 2024
- Last updated
- 22 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PAthwAy of Dyspneic patIent in Emergency in France
- ClinicalTrials.gov ID
- NCT06509854
- Acronym / sponsor ID
- Fr-PArADIse / 2022PI21
- Conditions
- Acute Dyspnea
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 89,700 participants (estimated)
- Lead sponsor
- Pr. Nicolas GIRERDUniversity, hospital or other
- Study start
- 30 Sep 2024 (estimated)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 30 Sep 2031 (estimated)
- First posted
- 19 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients treated in the emergency department for acute dyspnea.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- Cardiorespiratory arrest before emergency department management.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
12 secondary outcomes
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
Post admission mortality
Time frame: Within 20 years following hospital discharge
Post admission rehospitalization
Time frame: Within 20 years following hospital discharge
Erroneous etiological diagnosis of dyspnea in the emergency department
Time frame: Within hospital stay, maximum 21 days
All-cause mortality and specific mortality (cardiovascular and non-cardiovascular).
Time frame: Within 5 years following hospital discharge
Emergency post-admission mortality
Time frame: Within 20 years following hospital discharge
Emergency post-admission rehospitalisation
Time frame: Within 20 years following hospital discharge
Duration of stay in the emergency department
Time frame: Within hospital stay, maximum 21 days
Erroneous etiological diagnosis of dyspnea in the emergency department
Time frame: Within hospital stay, maximum 21 days
In-hospital mortality
Time frame: Within hospital stay, maximum 21 days
Length of hospital stay
Time frame: Within hospital stay, maximum 21 days
Post emergency admission (For dyspnea) mortality and rehospitalization
Time frame: Within 5 years following hospital discharge
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tahar CHOUIHED, MD, PhD principal investigator
Central Hospital, Nancy, France
Nicolas GIRERD, MD, PhD principal investigator
CHRU de Nancy
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Dyspnea, run by Pr. Nicolas GIRERD at 4 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nicolas GIRERD, MD, PhD (+33383157322, n.girerd@chru-nancy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All-cause post-hospitalization mortality and rehospitalization (time frame: Within 5 years following hospital discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2024.