NCT04327882

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
2,600

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2019

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 16, 2019

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 27, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 31, 2020

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 16, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 16, 2021

Completed
Last Updated

July 14, 2020

Status Verified

July 1, 2020

Enrollment Period

1.5 years

First QC Date

March 27, 2020

Last Update Submit

July 10, 2020

Conditions

Dyspnea

Keywords

Point-of-care systemUltrasonographyDyspnea

Outcome Measures

Primary Outcomes (1)

  • Diagnostic concordance

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

    Day 1

Secondary Outcomes (3)

  • Diagnostic concordance and expertise

    Day 1

  • Diagnostic performance of each ultrasound tool

    Day 1

  • Prognostic performance of each ultrasound tool

    Day 1

Interventions

Point-of-care ultrasoundDIAGNOSTIC_TEST

performance of a POCUS: lung and cardiac ultrasound mainly

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • Primary reason for emergency Department admission is dyspnea

You may not qualify if:

  • Pregnant or breastfeeding women
  • Persons not benefiting from a social security scheme
  • Persons deprived of liberty
  • Patient participates in another 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hôpital La Timone

Marseille, 13005, France

COMPLETED

CHU Nîmes

Nîmes, 30029, France

RECRUITING

Related Publications (1)

  • 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.

    PMID: 34813191DERIVED

MeSH Terms

Conditions

Dyspnea

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Markarian Thibaut

CONTACT

+33413429700Thibaut.MARKARIAN@ap-hm.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

March 27, 2020

First Posted

March 31, 2020

Study Start

September 16, 2019

Primary Completion

March 16, 2021

Study Completion

September 16, 2021

Last Updated

July 14, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Locations

FR(2)