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Contribution LUS in the Diagnosis of Acute Heart Failure (AHF) in Patients Admitted to the ED

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03717779
Recruitment Status : Completed
First Posted : October 24, 2018
Last Update Posted : January 16, 2019
Sponsor:
Information provided by (Responsible Party):
Pr. Semir Nouira, University of Monastir

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

Condition or disease Intervention/treatment
Dyspnea; Cardiac Diagnostic Test: lung ultrasound

Detailed 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 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.

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Study Type : Observational
Actual Enrollment : 600 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Contribution of Pulmonary Ultrasonography in the Diagnosis of Acute Heart Failure (AHF) in Patients Admitted to Emergency Department (ED) for Dyspnea
Actual Study Start Date : January 2, 2016
Actual Primary Completion Date : October 1, 2017
Actual Study Completion Date : October 1, 2017

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
HF/HFpEF
patients with heart failure with a preserved ejection fraction(HFpEF) perform LUS
Diagnostic Test: lung ultrasound
we perform a lung ultrasound to all the patients admitted for dyspnea independantly from the final diagnosis

HF/HFrEF
patients with heart failure with a reduced ejection fraction(HFrEF) perform LUS
Diagnostic Test: lung ultrasound
we perform a lung ultrasound to all the patients admitted for dyspnea independantly from the final diagnosis




Primary Outcome Measures :
  1. the accuracy of LUS in the diagnosis of heart failure [ Time Frame: 0 days ]
    the accuracy of LUS in the diagnosis of heart failure measured by sensitivity ,specificity, and area under the roc curve



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
all patients admitted to the ED with acute dyspnea, with the final diagnosis of heart failure by the ICU team
Criteria

Inclusion Criteria:

  • non traumatic dyspnea with the final diagnosis of heart failure

Exclusion Criteria:

  • coma,
  • shock,Mechanical Ventilation,
  • vasopressor drugs
  • arrhythmia serious and sustained,
  • non consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03717779


Locations
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Tunisia
Emergency department of university hospital Fattouma Bourguiba of Monastir
Monastir, Tunisia, 5000
Sponsors and Collaborators
University of Monastir
Investigators
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Principal Investigator: Nouira Semir, PHD University hospital of Monastir

Additional Information:
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Responsible Party: Pr. Semir Nouira, University of Monastir
ClinicalTrials.gov Identifier: NCT03717779    
Other Study ID Numbers: Lung Ultra Sound (LUS)
First Posted: October 24, 2018    Key Record Dates
Last Update Posted: January 16, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Pr. Semir Nouira, University of Monastir:
Lung ultrasound,
heart failure
diagnosis
accuracy
Additional relevant MeSH terms:
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Dyspnea
Heart Failure
Heart Diseases
Cardiovascular Diseases
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms