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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • France
      • Marseille, France, 13005
        • Completed
        • Hôpital La Timone
      • Nîmes, France, 30029

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Centre Hospitalier Universitaire de Nīmes

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.

General Publications

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 16, 2019

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 16, 2021

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 16, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 27, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 30, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 31, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 14, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 10, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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