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

NCT ID: NCT05352490

Last Updated: 2022-08-09

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 350 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-03-01
• Study Completion Date: 2023-05-31

Brief 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.

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 ).

Conditions

Dyspnea; Decompensated Heart Failure ; COPD Exacerbation

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

HF-group

patients with AECOPD and acute heart failure

calculate LUS score

Intervention Type: DIAGNOSTIC_TEST

calculate LUS score

non HF-group

patients with AECOPD without acute heart failure

calculate LUS score

Intervention Type: DIAGNOSTIC_TEST

calculate LUS score

Interventions

calculate LUS score

calculate LUS score

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Monastir

OTHER

Sponsor Role: lead

Responsible Party

Pr. Semir Nouira

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nouira semir Nouira semir, professor

Role: STUDY_DIRECTOR

Principal Investigator university

Locations

Emergency Departement

Monastir, , Tunisia

Site Status: RECRUITING

Countries

Tunisia

Central Contacts

Semir Nouira Semir Nouira, Professor

Role: CONTACT

semir.nouira@rns.tn

73532014 ext. 216

Adel sekma Adel sekma, MD

Role: CONTACT

adelsekma@hotmail.fr

93031612 ext. 216

Facility Contacts

Semir Nouira, professor

Role: primary

semir.nouira@rns.tn

73 106 085 ext. 216

Bel Haj Ali Khaoula, MD

Role: backup

belhajalikhaoula@yahoo.fr

29777277 ext. 216

Related Links

http://www.urgencemonastir.com

official department website

Other Identifiers

Lung ultrasound, COPD, HF

Identifier Type: -

Identifier Source: org_study_id