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

Contribution LUS and Reproducibility of Lung Ultrasound in the Diagnosis of Acute Heart Failure in the Emergency Department (ED)

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.

Study Overview

• Status: Completed
• Conditions: Dyspnea; Cardiac

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 ).

• Study Type: Observational
• Enrollment (Actual): 1024

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

• non traumatic dyspnea with the final diagnosis of heart failure

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Monastir

Publications and helpful links

Helpful Links

• official department website

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 1, 2016
• Primary Completion (ACTUAL): January 1, 2017
• Study Completion (ACTUAL): January 1, 2017

Study Registration Dates

• First Submitted: July 6, 2018
• First Submitted That Met QC Criteria: September 5, 2018
• First Posted (ACTUAL): September 6, 2018

Study Record Updates

• Last Update Posted (ACTUAL): March 17, 2022
• Last Update Submitted That Met QC Criteria: March 16, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Lung ultrasound; heart failure; diagnosis
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Heart Failure; Dyspnea
• Other Study ID Numbers: LUS/HF

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No