CClinicalTrials.gg
CompletedNCT03660592Updated Mar 17, 2022

Contribution and Reproducibility of Lung Ultrasound in the Diagnosis of Acute Heart Failure in the ED

An observational study in Dyspnea; Cardiac, sponsored by University of Monastir. Completed. Open to participants aged 18 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-03-17.

Sponsored by University of Monastir · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
1,024
Ages
18 Years to 90 Years
Sex
All
01

Study 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.

Read the detailed description

Dyspnea is one of the most distressing situations for the patient . Emergency cases do not always present in conditions that are ideal for immediate diagnosis, which sometimes compromises outcome. Physical examination, laboratory findings and radiography are imperfect, resulting in a need for sophisticated test results that delay management.

Lung ultrasonography is becoming a standard tool in critical cases in the ED.

the investigators aim to perform ultrasonography on consecutive patients admitted to the ICU with dyspnea, comparing lung ultrasonography results on initial presentation with the final diagnosis by the ICU team.

Three items were assessed: artifacts (horizontal A lines or vertical B lines indicating interstitial syndrome), lung sliding, and alveolar consolidation and/or pleural effusion, these items were grouped to assess ultrasound profiles.

This study assesses the potential of lung ultrasonography to diagnose heart failure.The second aim of this study was to evaluate the inter-observer reproducibility of LUS performed by ED residents in the evaluation of cardiac causes of acute dyspnea.

Patients presenting to the ED with acute dyspnea will be prospectively enrolled in this study. In each patient, LUS was performed by two ED residents blinded to clinical diagnoses.

AHF was determined on the base of clinical exam, chest x-ray , brain natriuretic peptide (BNP) and echocardiographic findings.

A patient lung comet score (LCS) was obtained by summing the number of comets in each of the scanned spaces.

Then the probability of AHF was defined as :

low probability (LCS\<15) intermediate probability (15 \<LCS\<30), and high probability (LCS>30 ).

02

Conditions studied

  • Dyspnea; Cardiac

Keywords

  • Lung ultrasound
  • heart failure
  • diagnosis
03

In context

Dyspnea

656 studies on the registry are indexed under Dyspnea; 153 are open to participants now.

This study's enrollment of 1,024 is above the median of 122 across 204 observational studies indexed under Dyspnea.

Browse Dyspnea studies →

Lead sponsor

University of Monastir is the lead sponsor of 112 studies on the registry; 30 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

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

Inclusion criteria

  • non traumatic dyspnea with the final diagnosis of heart failure

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
1,024 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

06

What researchers measure

Primary outcomes

  1. 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)

    Time frame: 0 days

  2. 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

    Time frame: 0 days

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 17, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03660592
Lead sponsor
University of Monastir
Responsible party
Pr. Semir Nouira (Pr Nouira Semir, University of Monastir) — Principal investigator
First posted
Sep 6, 2018
Start date
Oct 1, 2016
Primary completion
Jan 1, 2017
Completion
Jan 1, 2017
Last update
Mar 17, 2022

Study contacts

Nouira semir, professor
principal investigator · university of ùmonastir

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion