NCT03660592

Brief Summary

Discrimination between cardiac and non-cardiac causes of dyspnea can be challenging, causing excessive delay before adequate therapy. In clinical practice lung ultrasound (LUS) is becoming an easy and reliable noninvasive tool for the evaluation of dyspnea and can shorten the time to diagnosis .However the reproductibility of this test was not extensively studied.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
1,024

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2016

Shorter than P25 for all trials

Status
completed

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

October 1, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

July 6, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 6, 2018

Completed
Last Updated

March 17, 2022

Status Verified

March 1, 2022

Enrollment Period

3 months

First QC Date

July 6, 2018

Last Update Submit

March 16, 2022

Conditions

Dyspnea; Cardiac

Keywords

Lung ultrasoundheart failurediagnosis

Outcome Measures

Primary Outcomes (2)

  • the reproductibility of LUS in the diagnosis of heart failure

    the reproductibility of the LUS in the diagnosis of heart failure between two different operators (using the Kappa and the agreement index)

    0 days

  • the accuracy of LUS in the diagnosis of heart failure the accuracy of LUS in the diagnosis of heart failure measured by sensitivity ,specificity, and area under the roc curve

    the accuracy of LUS in the diagnosis of heart failure measured by sensitivity ,specificity, and area under the roc curve

    0 days

Study Arms (2)

operator 1

ED resident experimented in pulmonary ultrasonography and blinded to the final diagnosis

operator 2

a different ED resident experimented in pulmonary ultrasonography and blinded to the final diagnosis

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

all patients admitted to the ED with acute dyspnea, with the final diagnosis of heart failure

You may qualify if:

  • non traumatic dyspnea with the final diagnosis of heart failure

You may not qualify if:

  • impossibility to give consent to participate in the study
  • post traumatic dyspnea
  • pregnant women
  • need for endotracheal intubation or inotropic drugs
  • patients who were deemed too unstable for sonography by the treating team

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

DyspneaHeart FailureDisease

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and SymptomsHeart DiseasesCardiovascular DiseasesPathologic Processes

Study Officials

  • Nouira semir, professor

    university of ùmonastir

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Pr Nouira Semir

Study Record Dates

First Submitted

July 6, 2018

First Posted

September 6, 2018

Study Start

October 1, 2016

Primary Completion

January 1, 2017

Study Completion

January 1, 2017

Last Updated

March 17, 2022

Record last verified: 2022-03