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

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ClinicalTrials.gov Identifier: NCT04327882
Recruitment Status : Recruiting
First Posted : March 31, 2020
Last Update Posted : March 31, 2020
Sponsor:
Information provided by (Responsible Party):
Xavier Bobbia, Centre Hospitalier Universitaire de Nīmes

Brief 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. 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.

Condition or disease Intervention/treatment
Dyspnea Diagnostic Test: Point-of-care ultrasound

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 dyspeic 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 CTE 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 CTE 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.

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Study Type : Observational
Estimated Enrollment : 2600 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Interest of Clinical Ultrasound in Patients Consulting for Dyspnea in the Emergency Department: an Observational Bicentric Study
Actual Study Start Date : September 16, 2019
Estimated Primary Completion Date : March 16, 2021
Estimated Study Completion Date : September 16, 2021

Resource links provided by the National Library of Medicine



Intervention Details:
  • Diagnostic Test: Point-of-care ultrasound
    performance of a POCUS: lung and cardiac ultrasound mainly


Primary Outcome Measures :
  1. Diagnostic concordance [ Time Frame: Day 1 ]
    Diagnostic concordance between the POCUS diagnosis in emergency department dyspneic patients and the emergency department discharge diagnosis


Secondary Outcome Measures :
  1. Diagnostic concordance and expertise [ Time Frame: Day 1 ]
    Diagnostic concordances based on the level of ultrasound expertise of emergency department practitioners

  2. Diagnostic performance of each ultrasound tool [ Time Frame: Day 1 ]
    Diagnostic performance of each ultrasound tool used: each pulmonary ultrasound profile, each echocardiographic evaluation or measurement.

  3. Prognostic performance of each ultrasound tool [ Time Frame: Day 1 ]
    Prognostic performance of each ultrasound tool used: each pulmonary ultrasound profile, each echocardiographic evaluation or measurement.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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.
Criteria

Inclusion Criteria:

  • Primary reason for emergency Department admission is dyspnea

Exclusion Criteria:

  • 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.
  • Patient refuses to participate
  • It proves impossible to give informed information about the subject matter
  • The patient is not fluent in French.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04327882


Contacts
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Contact: Markarian Thibaut +33413429700 Thibaut.MARKARIAN@ap-hm.fr

Locations
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France
Hôpital La Timone Recruiting
Marseille, France, 13005
Contact: Markarian Thibaut, MD    +33413429700    Thibaut.MARKARIAN@ap-hm.fr   
CHU Nîmes Recruiting
Nîmes, France, 30029
Contact: Bobbia Xavier    +33466683050    xavier.bobbia@gmail.com   
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nīmes
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Responsible Party: Xavier Bobbia, Doctor, Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier: NCT04327882    
Other Study ID Numbers: XBobbia/ECUDYS
First Posted: March 31, 2020    Key Record Dates
Last Update Posted: March 31, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Xavier Bobbia, Centre Hospitalier Universitaire de Nīmes:
Point-of-care system
Ultrasonography
Dyspnea
Additional relevant MeSH terms:
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Dyspnea
Emergencies
Disease Attributes
Pathologic Processes
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms