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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05126940
Other study ID # LR12SP18
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2018
Est. completion date January 31, 2019

Study information

Verified date November 2021
Source University of Monastir
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study assesses the potential of lung ultrasonography to diagnose heart failure.


Description:

Dyspnea is one of the most distressing situations for the patient . Emergency cases do not always present in conditions that are ideal for immediate diagnosis, which sometimes compromises outcome. 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 consecutive patients admitted to the ICU with dyspnea, comparing lung ultrasonography results on initial presentation with the final diagnosis by the nurses. 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. the study aimed to evaluate the accuracy and reproducibility of B-lines testing assessed by emergency nurses after 12-h training in the diagnosis of HF in patients admitted to the emergency department with acute dyspnea.


Recruitment information / eligibility

Status Completed
Enrollment 216
Est. completion date January 31, 2019
Est. primary completion date January 31, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - non traumatic dyspnea with the final diagnosis of heart failure Exclusion Criteria: - age less than 18 years - impossibility to give consent to participate in the study - post-traumatic dyspnea - pregnant women - need for endotracheal intubation or inotropic drugs - patients who were deemed too unstable for sonography by the treating team

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
we perform a lung ultrasound to all the patients admitted for dyspnea independantly from the final diagnosis
Patients were placed in a semi-recumbent or supine position depending on their respiratory tolerance. For each side of the chest, 4 zones have to be assessed : 2 anterior and 2 lateral. The operator should calculate the number of B-lines when present .

Locations

Country Name City State
Tunisia Nouira Semir 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 the accuracy of LUS performed by nurses in the diagnosis of heart failure the accuracy of LUS in the diagnosis of heart failure measured by sensitivity . 0 days
Primary the Specificity of LUS by nurses in the diagnosis of heart failure the accuracy of LUS in the diagnosis of heart failure measured by specificity. 0 days
Primary the reproducibility of LUS in by nurses the diagnosis of heart failure the accuracy of LUS in the diagnosis of heart failure measured by area under the roc curve 0 days
Primary Agreement between nurses and expert's Agreement between nurses and expert's interpretation was assessed by kappa agreement index for ordinal LUS scale classification 0 days
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