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

Sponsor
University of Monastir (Other)
Overall Status
Recruiting
CT.gov ID
NCT05352490
Collaborator
(none)
350
1
14
25

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Anticipated Enrollment :
350 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Diagnosis of Heart Failure in Chronic Obstructive Pulmonary Disease Using the Lung Ultrasound
Actual Study Start Date :
Mar 1, 2022
Anticipated Primary Completion Date :
May 1, 2023
Anticipated Study Completion Date :
May 1, 2023

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. LUS in COPD patients whith pulmonory echography [1day]

    LUS measured whith pulmonory echography by the number of lines A and B.

  2. the accuracy of LUS in the diagnosis of heart failure in COPD patients [1day]

    the accuracy of LUS in the diagnosis of heart failure in patients with COPD measured by area under the roc curve

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Emergency Departement Monastir Tunisia 5000

Sponsors and Collaborators

  • University of Monastir

Investigators

  • Study Director: Nouira semir Nouira semir, professor, Principal Investigator university

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Pr. Semir Nouira, Professor, University of Monastir
ClinicalTrials.gov Identifier:
NCT05352490
Other Study ID Numbers:
  • Lung ultrasound, COPD, HF
First Posted:
Apr 28, 2022
Last Update Posted:
Aug 9, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Pr. Semir Nouira, Professor, University of Monastir
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 9, 2022