Diagnosis of Heart Failure in Chronic Obstructive Pulmonary Disease Using the Lung Ultrasound

Acute Heart failure (AHF) is a common cause of acute exacerbation of chronic obstructive pulmonary disease (AECOPD). This association is frequently underestimated with regard to the difficulty of clinical diagnosis. The investigators expect that the application of the lung ultrasound could be useful in this issue.

Study Overview

• Status: Recruiting
• Conditions: Dyspnea; Decompensated Heart Failure ; COPD Exacerbation
• Intervention / Treatment: Diagnostic test: calculate LUS score

Detailed Description

Chronic obstructive pulmonary disease (COPD) is a frequent disease in our population affecting mainly the elderly and males. Dyspnea is the most common reason for consultation for patients with COPD in ED. Distinguishing between pulmonary and/or cardiac origin can be challenging.Physical examination, laboratory findings and radiography are imperfect. Lung ultrasound sonography (LUS) has recently gained a large place in the diagnosis of heart failure (HF), but its contribution to the diagnosis of HF in COPD remains poorly studied.

Purpose: The purpose of this study is to assess the contribution of LUS in the diagnosis of HF in COPD patients with acute dyspnea

. 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 COPD 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.This study includes patients with COPD consulting for acute dyspnea. We performed a lung ultrasound on all patients included. The diagnosis of heart failure (HF) was based on clinical, radiological, cardiac-ultrasound and expert data. The LUS diagnostic performance indicators were calculated using the different cut-off proposed by the LUS score.Then the probability of AHF was defined as : low probability (LUS<15) intermediate probability (15≤ LUS<30), and high probability (LUS≥30 ).

• Study Type: Observational
• Enrollment (Anticipated): 350

Contacts and Locations

• Study Contact: Name: Semir Nouira Semir Nouira, Professor; Phone Number: 216 73532014; Email: semir.nouira@rns.tn
• Study Contact Backup: Name: Adel sekma Adel sekma, MD; Phone Number: 216 93031612; Email: adelsekma@hotmail.fr

Study Locations

• Tunisia
  • Monastir, Tunisia, 5000
    • Recruiting
    • Emergency Departement
    • Contact: Bel Haj Ali Khaoula, MD; Phone Number: 216 29777277; Email: belhajalikhaoula@yahoo.fr

Participation Criteria

Eligibility Criteria

• 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

patients with history of COPD admitted to the emergency departmet for dyspnea

Description

Inclusion Criteria:

• patients with history of COPD admitted to the emergency department for dyspnea non traumatic dyspnea

Exclusion Criteria:

• instable hemodynamic or neurological status non consent to participate in the study

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
HF-group; patients with AECOPD and acute heart failure	Diagnostic test: calculate LUS score; calculate LUS score
non HF-group; patients with AECOPD without acute heart failure	Diagnostic test: calculate LUS score; calculate LUS score

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
LUS in COPD patients whith pulmonory echography	LUS measured whith pulmonory echography by the number of lines A and B.	1day
the accuracy of LUS in the diagnosis of heart failure in COPD patients	the accuracy of LUS in the diagnosis of heart failure in patients with COPD measured by area under the roc curve	1day

Collaborators and Investigators

• Sponsor: University of Monastir
• Investigators: Study Director: Nouira semir Nouira semir, professor, Principal Investigator university

Publications and helpful links

Helpful Links

• official department website

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2022
• Primary Completion (Anticipated): May 1, 2023
• Study Completion (Anticipated): May 1, 2023

Study Registration Dates

• First Submitted: March 9, 2022
• First Submitted That Met QC Criteria: April 22, 2022
• First Posted (Actual): April 28, 2022

Study Record Updates

• Last Update Posted (Actual): August 9, 2022
• Last Update Submitted That Met QC Criteria: August 6, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: COPD Acute Heart Failure Lung ultrasound
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Signs and Symptoms, Respiratory; Heart Failure; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Dyspnea
• Other Study ID Numbers: Lung ultrasound, COPD, 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