Enhanced FoCUS in Patients With Shortness of Breath

NCT ID: NCT05403619

Last Updated: 2022-06-03

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 119 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-01-01
• Study Completion Date: 2021-09-01

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.

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.

Conditions

Shortness of Breath; Acute Respiratory Failure

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Patients

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

Diagnostic test

Intervention Type: DIAGNOSTIC_TEST

Cardiac Ultrasound in order to explore the causes of shortness of breath

Interventions

Diagnostic test

Cardiac Ultrasound in order to explore the causes of shortness of breath

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

Focused cardiac Ultrasound

Eligibility Criteria

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

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nantes University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Nantes University Hospital

Nantes, , France

Countries

France

Other Identifiers

eFOCUS 1

Identifier Type: -

Identifier Source: org_study_id