eFOCUS: Enhanced FoCUS in Patients With Shortness of Breath

Sponsor
Nantes University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT05403619
Collaborator
(none)
119
1
44
2.7

Study Details

Study Description

Brief Summary

Retrospective observational study performed in a internal medicine ward of a French university hospital. Included patients were hospitalized for acute shortness of breath who have benefited from a eFOCUS which was defined as a focused cardiac Ultrasound with utilization of Doppler measurements.

The objectives were the therapeutic and diagnosis changes induced by eFoCUS. The primary endpoint was defined by the pooled introduction or discontinuation of diuretics, antibiotics or anticoagulants associated with eFoCUS results.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Diagnostic test

Detailed Description

It was a retrospective observational study performed in a internal medicine ward of a French University Hospital. Patients were identified in the hospital database, pertinent features and eFoCUS findings were extracted and anonymized.

Inclusion criteria:
  • Adult patients admitted to an internal medicine ward from the ED for acute shortness of breath.

  • Realization of an eFoCUS prescribed by the physician in charge of the patient

Exclusion criteria:

• Comprehensive echocardiography already performed Methods For each identified patient, pertinent data (demography, initial diagnosis and treatment (diuretics, antibiotics, anticoagulants)) and eFoCUS findings were extracted from the hospital files, anonymized and entered in a LibreOffice spreadsheet. Extracted diagnosis were gathered into the following categories: Community-acquired pneumonia (CAP), Acute cardiogenic pulmonary edema (ACPE), Pulmonary embolism (PE), Chronic Obstructive Pulmonary Disease (COPD) and other (OTHER).

Objectives and endpoints

  • The main objective was the therapeutic change induced by eFoCUS. The primary endpoint was defined by the pooled introduction or discontinuation of diuretics, antibiotics or anticoagulants associated with eFoCUS results.

  • The secondary objectives were diagnosis modifications induced by eFoCUS. Data analysis

  • Numerical data were presented as mean ± SD or as median with interquartile range depending on the normality. The paired Student's t-test was used to compare normally distributed data. The chi-square test was used for the comparison of noncontinuous variables expressed as proportions. A p-value <0.05 was considered significant. All p-values were two-sided. Statistical analysis was realized with R (4.03.3) in the Rstudio® environment.

Study Design

Study Type:
Observational
Actual Enrollment :
119 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Impact of an Enhanced Focused Cardiac Ultrasound on Treatment Modifications in a Population of Internal Medicine Patients: Retrospective Study
Actual Study Start Date :
Jan 1, 2018
Actual Primary Completion Date :
Jul 1, 2021
Actual Study Completion Date :
Sep 1, 2021

Arms and Interventions

Arm Intervention/Treatment
Patients

Patients hospitalized for shortness of breath with realization of an enhanced FoCUS

Diagnostic Test: Diagnostic test
Cardiac Ultrasound in order to explore the causes of shortness of breath
Other Names:
  • Focused cardiac Ultrasound
  • Outcome Measures

    Primary Outcome Measures

    1. Pooled introduction or discontinuation of diuretics, antibiotics or anticoagulants [up to 24 hours after eFoCUS]

      Number of patients for whom there was an introduction or discontinuation of diuretics, antibiotics or anticoagulants associated with Focused cardiac ultrasound

    Secondary Outcome Measures

    1. Changes of diagnostic categories associated with eFOCUS [up to 24 hours after eFoCUS]

      Number of patients for whom the diagnostic category (pneumonia, acute cardiac failure, pulmonary embolism, COPD, other) was modified after Focused cardiac ultrasound

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    21 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Adult patients admitted to a internal medicine ward from the ED for acute shortness of breath.

    • Realization of an eFoCUS prescribed by the physician in charge of the patient

    Exclusion Criteria:
    • Comprehensive echocardiography already performed

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Nantes University Hospital Nantes France 44093

    Sponsors and Collaborators

    • Nantes University Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Nantes University Hospital
    ClinicalTrials.gov Identifier:
    NCT05403619
    Other Study ID Numbers:
    • eFOCUS 1
    First Posted:
    Jun 3, 2022
    Last Update Posted:
    Jun 3, 2022
    Last Verified:
    May 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Nantes University Hospital
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jun 3, 2022