Enhanced FoCUS in Patients With Shortness of Breath

Acute Respiratory Failure Clinical Trial

— eFOCUS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05403619
• Other study ID #: eFOCUS 1
• Status: Completed
• Start date: January 1, 2018
• Est. completion date: September 1, 2021

Study information

• Verified date: May 2022
• Source: Nantes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 119
• Est. completion date: September 1, 2021
• Est. primary completion date: July 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Respiratory Failure
• Dyspnea
• Respiratory Insufficiency
• Shortness of Breath

Intervention

Diagnostic Test:
• Diagnostic test
Cardiac Ultrasound in order to explore the causes of shortness of breath

Locations

Country	Name	City	State
France	Nantes University Hospital	Nantes

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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