LUS: Bedside Lung Ultrasonography by Nurses in Acute Dyspnea.

Sponsor
University of Monastir (Other)
Overall Status
Completed
CT.gov ID
NCT05126940
Collaborator
(none)
216
1
13
16.6

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: we perform a lung ultrasound to all the patients admitted for dyspnea independantly from the final diagnosis

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 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.

Study Design

Study Type:
Observational
Actual Enrollment :
216 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Bedside Lung Ultrasonography by Emergency Department Nurses as an Aid for Identifying Heart Failure in Patients With Acute Dyspnea
Actual Study Start Date :
Jan 1, 2018
Actual Primary Completion Date :
Jan 31, 2019
Actual Study Completion Date :
Jan 31, 2019

Arms and Interventions

Arm Intervention/Treatment
nurses

ED nurses trained to perform LUS and blinded to the final diagnosis

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 .
Other Names:
  • lus
  • emergency physician

    certified emergency physician who had accomplished a full mentoring program for "Ultra-Sound Life Support".

    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 .
    Other Names:
  • lus
  • Outcome Measures

    Primary Outcome Measures

    1. the accuracy of LUS performed by nurses in the diagnosis of heart failure [0 days]

      the accuracy of LUS in the diagnosis of heart failure measured by sensitivity .

    2. the Specificity of LUS by nurses in the diagnosis of heart failure [0 days]

      the accuracy of LUS in the diagnosis of heart failure measured by specificity.

    3. the reproducibility of LUS in by nurses the diagnosis of heart failure [0 days]

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

    4. Agreement between nurses and expert's [0 days]

      Agreement between nurses and expert's interpretation was assessed by kappa agreement index for ordinal LUS scale classification

    Eligibility Criteria

    Criteria

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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Nouira Semir Monastir Tunisia 5000

    Sponsors and Collaborators

    • University of Monastir

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Pr. Semir Nouira, professor, University of Monastir
    ClinicalTrials.gov Identifier:
    NCT05126940
    Other Study ID Numbers:
    • LR12SP18
    First Posted:
    Nov 19, 2021
    Last Update Posted:
    Nov 19, 2021
    Last Verified:
    Nov 1, 2021
    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 Nov 19, 2021