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DyspneaECUDYSNCT04327882

Point-of-care Ultrasound Interest in Dyspneic Emergency Department Patients: an Observational Bicentric Study

An observational study of Dyspnea, run by Centre Hospitalier Universitaire de Nīmes at 2 sites in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The diagnostic value of Point-of-care ultrasound (POCUS) in emergency department (ED) dyspneic patients is shown by numerous studies with a limited number of patients. Recently, Zanobetti et al. showed the POCUS diagnostic performance in dyspneic patients in 2600 patients. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Dyspnea
What is being tested?
Point-of-care ultrasound
How many people
2,600 participants
Where
2 sitesFrance
Study dates
16 Sep 2019to 16 Sep 2021
Phase
Observational
Are there results?
None posted in the registry

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: All patients managed in both investigative emergency departments whose primary reason for management is dyspnea may be included. Patients with POCUS are included.

Who may be able to join

  • Primary reason for emergency Department admission is dyspnea

Who cannot join

  • Pregnant or breastfeeding women
  • Persons not benefiting from a social security scheme
  • Persons deprived of liberty
  • Patient participates in another study
  • The patient is in a period of exclusion determined by a previous study.
  • The patient is under legal protection, guardianship or trusteeship.
Show all 9Show fewer
  • Patient refuses to participate
  • It proves impossible to give informed information about the subject matter
  • The patient is not fluent in French.

Trial locations and contacts

2 sites in 1 country.

Markarian Thibaut contact

+33413429700

Thibaut.MARKARIAN@ap-hm.fr

France2 sites, 1 recruiting

  • Hôpital La Timone

    Marseille, 13005

    Completed

  • CHU Nîmes

    Nîmes, 30029

    Bobbia Xavier, +33466683050, xavier.bobbia@gmail.com

    Recruiting

Other trials in France

About this study

Official title: Interest of Clinical Ultrasound in Patients Consulting for Dyspnea in the Emergency Department: an Observational Bicentric Study

The diagnostic value of Point-of-care ultrasound (POCUS) in emergency department (ED) dyspneic patients is shown by numerous studies with a limited number of patients. Recently, Zanobetti et al. showed the POCUS diagnostic performance in dyspneic patients in 2600 patients. This study was monocentric and few physicians performed the ultrasounds. Moreover they were experts. The POCUS diagnostic performance performed in a large number of dyspneic ED patients by many physicians with heterogeneous experience is not known. The investigators are carrying out a bicentric study in two large medical teams routinely practicing POCUS. The main objective of this study is to show the diagnostic concordance between the diagnosis resulting from the POCUS results in emergency department dyspneic patients and the diagnosis of discharge from the emergency department in a large medical team with a heterogeneous level of training and experience. The secondary objective is to study these different diagnostic concordances according to the level of ultrasound expertise of the ER practitioners.

Read the detailed description
  • Status of the issue and objective of the research Emergency Clinical Ultrasound (ECU) has shown excellent diagnostic relevance in patients presenting to emergency departments for dyspnea. A recent study including more than 2600 dyspneic patients in the emergency department shows that the diagnosis made with the ECU alone has a good concordance with the diagnosis of end of management in the emergency department but with a significantly shorter duration of obtaining it (186 ± 72 min vs 24 ± 10 min p = 0.025). This study, like many on the ECU, shows good performance when ultrasound is performed by experts. Confirmation that the ECU has a diagnostic performance comparable to all the examinations performed in the standard management of dyspneic patients, when applied by a large team of emergency physicians, is a necessity. The main objective of this study is to show the diagnostic concordance between the diagnosis resulting from the results of the ECU in dyspneic patients in the emergency department and the diagnosis at discharge from the emergency department in a large medical team with a heterogeneous level of training and experience. The secondary objective is to study these different diagnostic concordances according to the level of ultrasound expertise of the ER practitioners.
  • Population :

Adult patients (> 18 years old) admitted to the emergency department for a main reason of dyspnea.

  • Method of observation : This will be a prospective bicentric observational study.
  • Origin and nature of nominative data collected. Data collected from computerized patient records.
  • Mode of data flow The data collected will be noted on an anonymized Excel file for analysis.
  • Duration and organization of the research Expected duration: 2 years, including an 18-month inclusion period to allow for the inclusion of 2600 patients. Data is collected by the trial investigators.
  • Method of data analysis Descriptive statistical analysis and comparison of concordance between different diagnostic methods
  • Justification of the number of subjects or power analysis. 2600 to allow comparison with the original publication.
Conditions
Dyspnea
Being tested
Point-of-care ultrasound
Keywords
Point-of-care system, Ultrasonography, Dyspnea
Medical subject headings
Dyspnea

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Point-of-care ultrasoundDiagnostic test

    performance of a POCUS: lung and cardiac ultrasound mainly

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Diagnostic concordance

    Diagnostic concordance between the POCUS diagnosis in emergency department dyspneic patients and the emergency department discharge diagnosis

    Measured: Day 1

Secondary outcomes (3)

  1. Diagnostic concordance and expertise

    Diagnostic concordances based on the level of ultrasound expertise of emergency department practitioners

    Measured: Day 1

  2. Diagnostic performance of each ultrasound tool

    Diagnostic performance of each ultrasound tool used: each pulmonary ultrasound profile, each echocardiographic evaluation or measurement.

    Measured: Day 1

  3. Prognostic performance of each ultrasound tool

    Prognostic performance of each ultrasound tool used: each pulmonary ultrasound profile, each echocardiographic evaluation or measurement.

    Measured: Day 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Mar 2020
  2. Study start16 Sep 2019
  3. Primary completion16 Mar 2021 (estimated)
  4. Study completion16 Sep 2021 (estimated)

Resources

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
Prospective
Enrolment
2,600 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04327882
Sponsor's protocol ID
XBobbia/ECUDYS
Acronym
ECUDYS
Status last verified
Jul 2020
First submitted
27 Mar 2020
Last updated
14 Jul 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Vauthier C, Chabannon M, Markarian T, Taillandy Y, Guillemet K, Krebs H, Bazalgette F, Muller L, Claret PG, Bobbia X. Point-of-care chest ultrasound to diagnose acute heart failure in emergency department patients with acute dyspnea: diagnostic performance of an ultrasound-based algorithm. Emergencias. 2021 Dec;33(6):441-446. English, Spanish.

    PubMed 34813191

Questions about this trial

What is this clinical trial studying?

An observational study of Dyspnea, run by Centre Hospitalier Universitaire de Nīmes at 2 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 1 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 14 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Markarian Thibaut (+33413429700, Thibaut.MARKARIAN@ap-hm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Diagnostic concordance (time frame: Day 1). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04327882, which also lists 1 linked publication.

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 14 Jul 2020.

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