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

Dyspnea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05352490
• Other study ID #: Lung ultrasound, COPD, HF
• Status: Recruiting
• Start date: March 1, 2022
• Est. completion date: May 2023

Study information

• Verified date: August 2022
• Source: University of Monastir
• Contact: Semir Nouira Semir Nouira, Professor
• Phone: 73532014
• Email: semir.nouira[@]rns.tn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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 ).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 350
• Est. completion date: May 2023
• Est. primary completion date: May 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dyspnea
• Heart Failure
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Diagnostic Test:
• calculate LUS score
calculate LUS score

Locations

Country	Name	City	State
Tunisia	Emergency Departement	Monastir

Sponsors (1)

Lead Sponsor	Collaborator
University of Monastir

Country where clinical trial is conducted

Tunisia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	LUS in COPD patients whith pulmonory echography	LUS measured whith pulmonory echography by the number of lines A and B.	1day
Primary	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

External Links

•   official department website