DyspneaN_E_PARADISENCT06235008
PAthwAy of Dyspneic patIent in Emergency in the North-east Region (North-East PArADIsE)
An observational study of Dyspnea, run by Pr. Nicolas GIRERD at 1 site in France.
Trial summary
This is an observational retrospective multi-center study in patients managed for acute dyspnea by Emergency department medical team. The main aim of the study is to evaluate factors associated with mortality risks in patients managed for acute dyspnea by an Emergency department medical team, overall, as well as in… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dyspnea
- How many people
- 75,000 participants
- Where
- 1 siteFrance
- Study dates
- 31 Mar 2024to 30 Sep 2030
- 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: Patients with acute dyspnea cared by a medical team of the emergencies of CHRU of Nancy, CHR Metz-Thionville and CH d'Epinal
Who may be able to join
- Man or women ≥ 18 years
- Patients with acute dyspnea cared by a medical team of the emergencies of CHRU of Nancy, CHR Metz-Thionville and CH d'Epinal.
Who cannot join
- Cardiorespiratory arrest before medical management by the Emergency Department team
- Adults under legal protection
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
CHRU
Nancy
CHOUIHED Tahar, 0383157322 ext. +33, t.chouihed@chru-nancy.fr
About this study
Official title: PAthwAy of Dyspneic patIent in Emergency in the North-east Region
This is an observational retrospective multi-center study in patients managed for acute dyspnea by Emergency department medical team.
The main aim of the study is to evaluate factors associated with mortality risks in patients managed for acute dyspnea by an Emergency department medical team, overall, as well as in subgroups of interest (male/female, age categories, mode of admission and comorbidities).
- Conditions
- Dyspnea
- Medical subject headings
- Dyspnea
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause mortality
Measured: Within 5 years following hospital discharge
Secondary outcomes (11)
Main diagnosis during the initial hospitalization
Measured: Within hospital stay, maximum 21 days
Mismatch between diagnosis in the Emergency department and at discharge
Difference between the diagnosis reported in the Emergency department file and the diagnosis reported at hospital discharge.
Measured: Within hospital stay, maximum 21 days
Length of hospital stay
Measured: Within hospital stay, maximum 21 days
Administration of non-invasive ventilation
Measured: Within hospital stay, maximum 21 days
Timing of non-invasive ventilation
Measured: Within hospital stay, maximum 21 days
Administration of diuretics
Measured: Within hospital stay, maximum 21 days
Timing of diuretics
Measured: Within hospital stay, maximum 21 days
Post emergency admission
Type of department admitting the patient following emergency care (intensive care unit, cardiology unit, cardiac intensive care unit, post-emergency department, other...)
Measured: Within hospital stay, maximum 21 days
All-cause hospital mortality
Measured: Within hospital stay, maximum 30 days
Readmissions (all-cause and related to acute dyspnea) to the emergency department
Measured: Within 5 years after admission
Congestion score
Assessed by: Congestion score assessed on chest X-ray on admission to the emergency department. The congestion score ranges from 0 (indicating no congestion signs) to 3 (indicating intense congestion).
Measured: Within 2 days of admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2024
- Study start31 Mar 2024 (estimated)
- Primary completion31 Mar 2029 (estimated)
- Study completion30 Sep 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- 75,000 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06235008
- Sponsor's protocol ID
- 2020PI059
- Acronym
- N_E_PARADISE
- Status last verified
- Jan 2024
- First submitted
- 9 Jan 2024
- Last updated
- 31 Jan 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 31 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PAthwAy of Dyspneic patIent in Emergency in the North-east Region
- ClinicalTrials.gov ID
- NCT06235008
- Acronym / sponsor ID
- N_E_PARADISE / 2020PI059
- Conditions
- Dyspnea
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 75,000 participants (estimated)
- Lead sponsor
- Pr. Nicolas GIRERDUniversity, hospital or other
- Study start
- 31 Mar 2024 (estimated)
- Primary completion
- 31 Mar 2029 (estimated)
- Study completion
- 30 Sep 2030 (estimated)
- First posted
- 31 Jan 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 is an observational retrospective multi-center study in patients managed for acute dyspnea by Emergency department medical team.
The main aim of the study is to evaluate factors associated with mortality risks in patients managed for acute dyspnea by an Emergency department medical team, overall, as well as in subgroups of interest (male/female, 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
- Patients with acute dyspnea cared by a medical team of the emergencies of CHRU of Nancy, CHR Metz-Thionville and CH d'Epinal
Key inclusion criteria (2 listed)
- Man or women ≥ 18 years
- Patients with acute dyspnea cared by a medical team of the emergencies of CHRU of Nancy, CHR Metz-Thionville and CH d'Epinal.
Key exclusion criteria (2 listed)
- Cardiorespiratory arrest before medical management by the Emergency Department team
- Adults under legal protection
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 mortality
Time frame: Within 5 years following hospital discharge
11 secondary outcomes
Main diagnosis during the initial hospitalization
Time frame: Within hospital stay, maximum 21 days
Mismatch between diagnosis in the Emergency department and at discharge
Time frame: Within hospital stay, maximum 21 days
Length of hospital stay
Time frame: Within hospital stay, maximum 21 days
Administration of non-invasive ventilation
Time frame: Within hospital stay, maximum 21 days
Timing of non-invasive ventilation
Time frame: Within hospital stay, maximum 21 days
Administration of diuretics
Time frame: Within hospital stay, maximum 21 days
Timing of diuretics
Time frame: Within hospital stay, maximum 21 days
Post emergency admission
Time frame: Within hospital stay, maximum 21 days
All-cause hospital mortality
Time frame: Within hospital stay, maximum 30 days
Readmissions (all-cause and related to acute dyspnea) to the emergency department
Time frame: Within 5 years after admission
Congestion score
Time frame: Within 2 days of admission
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 31 Jan 2024.
Related trials for Dyspnea
Not yet recruiting
Mechanical Ventilator Adjustments and Patient Dyspnea
Respiratory Failure, Dyspnea During Mechanical Ventilation
RecruitingPhase 3
A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Do Not Use a Breathing Machine (PAP) (VESPER-OSA 2)
Apnea, Sleep Disorders
Not yet recruiting
Lung Cancer and Aging: Improving Well-being for Older Adults With Lung Cancer
Lung Cancer
RecruitingPhase 2
A Study to Learn About the Study Medicine Called PF-07275315 in People With Moderate-To-Severe Asthma
Asthma
Recruiting
The Impact of Telemedicine, Using the Caller's Mobile Phone Camera, on the Quality of Care Provided to Adult Patients Contacting the 15 Centre for Acute Dyspnea
Dyspnea
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dyspnea, run by Pr. Nicolas GIRERD at 1 site 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 2 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 31 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 GIRERD Nicolas (0383157322 ext. +33, 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 mortality (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 31 Jan 2024.