Enhanced FoCUS in Patients With Shortness of Breath (eFOCUS)

Impact of an Enhanced Focused Cardiac Ultrasound on Treatment Modifications in a Population of Internal Medicine Patients: Retrospective Study

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.

Study Overview

• Status: Completed
• Conditions: Acute Respiratory Failure; Shortness of Breath
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 119

Contacts and Locations

Study Locations

• France
  • Nantes, France, 44093
    • Nantes University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients hospitalized for acute shortness of breath

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pooled introduction or discontinuation of diuretics, antibiotics or anticoagulants	Number of patients for whom there was an introduction or discontinuation of diuretics, antibiotics or anticoagulants associated with Focused cardiac ultrasound	up to 24 hours after eFoCUS

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes of diagnostic categories associated with eFOCUS	Number of patients for whom the diagnostic category (pneumonia, acute cardiac failure, pulmonary embolism, COPD, other) was modified after Focused cardiac ultrasound	up to 24 hours after eFoCUS

Collaborators and Investigators

• Sponsor: Nantes University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2018
• Primary Completion (Actual): July 1, 2021
• Study Completion (Actual): September 1, 2021

Study Registration Dates

• First Submitted: May 19, 2022
• First Submitted That Met QC Criteria: May 31, 2022
• First Posted (Actual): June 3, 2022

Study Record Updates

• Last Update Posted (Actual): June 3, 2022
• Last Update Submitted That Met QC Criteria: May 31, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Ultrasound; Pneumonia; Acute decompensated heart failure; Pulmonary Embolism
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Respiratory Insufficiency; Dyspnea
• Other Study ID Numbers: eFOCUS 1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No