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
|Condition or disease||Intervention/treatment|
|Dyspnea||Diagnostic Test: Point-of-care ultrasound|
- 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.
|Study Type :||Observational|
|Estimated Enrollment :||2600 participants|
|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|
- Diagnostic Test: Point-of-care ultrasound
performance of a POCUS: lung and cardiac ultrasound mainly
- Diagnostic concordance [ Time Frame: Day 1 ]Diagnostic concordance between the POCUS diagnosis in emergency department dyspneic patients and the emergency department discharge diagnosis
- Diagnostic concordance and expertise [ Time Frame: Day 1 ]Diagnostic concordances based on the level of ultrasound expertise of emergency department practitioners
- 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.
- 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.
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
|Contact: Markarian Thibaut||+33413429700||Thibaut.MARKARIAN@ap-hm.fr|