Clinical trial NCT05352490: Diagnosis of Heart Failure in Chronic Obstructive Pulmonary Disease Using the Lung Ultrasound
Official title: Diagnosis of Heart Failure in Chronic Obstructive Pulmonary Disease Using the Lung Ultrasound
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Dyspnea
Decompensated Heart Failure ; COPD Exacerbation
Keywords: COPD Acute Heart Failure Lung ultrasound
Lead sponsor: University of Monastir
Sponsor class: OTHER
First posted: 2022-04-28
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with history of COPD admitted to the emergency departmet for dyspnea

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 ).

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

Primary outcomes:
measure: LUS in COPD patients whith pulmonory echography
timeFrame: 1day
measure: the accuracy of LUS in the diagnosis of heart failure in COPD patients
timeFrame: 1day
Secondary outcomes:
Other outcomes:
Locations:
city: Monastir
country: Tunisia
facility: Emergency Departement
Study officials:
affiliation: Principal Investigator university
name: Nouira semir Nouira semir, professor
role: STUDY_DIRECTOR
References: