- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04327882
Point-of-care Ultrasound Interest in Dyspneic Emergency Department Patients: an Observational Bicentric Study (ECUDYS)
July 10, 2020 updated by: Xavier Bobbia, Centre Hospitalier Universitaire de Nīmes
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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.
Study Type
Observational
Enrollment (Anticipated)
2600
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Markarian Thibaut
- Phone Number: +33413429700
- Email: Thibaut.MARKARIAN@ap-hm.fr
Study Locations
-
-
-
Marseille, France, 13005
- Completed
- Hôpital La Timone
-
Nîmes, France, 30029
- Recruiting
- CHU Nimes
-
Contact:
- Bobbia Xavier
- Phone Number: +33466683050
- Email: xavier.bobbia@gmail.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
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.
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Diagnostic concordance
Time Frame: Day 1
|
Diagnostic concordance between the POCUS diagnosis in emergency department dyspneic patients and the emergency department discharge diagnosis
|
Day 1
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Diagnostic concordance and expertise
Time Frame: Day 1
|
Diagnostic concordances based on the level of ultrasound expertise of emergency department practitioners
|
Day 1
|
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.
|
Day 1
|
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.
|
Day 1
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 16, 2019
Primary Completion (Anticipated)
March 16, 2021
Study Completion (Anticipated)
September 16, 2021
Study Registration Dates
First Submitted
March 27, 2020
First Submitted That Met QC Criteria
March 30, 2020
First Posted (Actual)
March 31, 2020
Study Record Updates
Last Update Posted (Actual)
July 14, 2020
Last Update Submitted That Met QC Criteria
July 10, 2020
Last Verified
July 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- XBobbia/ECUDYS
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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