Shortness of BreatheFOCUSNCT05403619
Enhanced FoCUS in Patients With Shortness of Breath
An observational study of Shortness of Breath and Acute Respiratory Failure, run by Nantes University Hospital at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Shortness of Breath, Acute Respiratory Failure
- What is being tested?
- Diagnostic test
- How many people
- 119 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2018to 1 Sep 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients hospitalized for acute shortness of breath
Who may be able to join
- 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
Who cannot join
- Comprehensive echocardiography already performed
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Being tested
- Diagnostic test
- Keywords
- Acute decompensated heart failure, Pneumonia, Pulmonary Embolism, Ultrasound
- Medical subject headings
- Dyspnea, Pneumonia, Pulmonary Embolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diagnostic testDiagnostic test
Also called Focused cardiac Ultrasound
Cardiac Ultrasound in order to explore the causes of shortness of breath
| Study group | Role | What they receive |
|---|---|---|
| Patients | Patients hospitalized for shortness of breath with realization of an enhanced FoCUS Receives: Diagnostic Test: Diagnostic test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: up to 24 hours after eFoCUS
Secondary outcomes (1)
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
Measured: up to 24 hours after eFoCUS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2022
- Study start1 Jan 2018
- Primary completion1 Jul 2021
- Study completion1 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shortness of BreathStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 119 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05403619
- Sponsor's protocol ID
- eFOCUS 1
- Acronym
- eFOCUS
- Status last verified
- May 2022
- First submitted
- 19 May 2022
- Last updated
- 3 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of an Enhanced Focused Cardiac Ultrasound on Treatment Modifications in a Population of Internal Medicine Patients: Retrospective Study
- ClinicalTrials.gov ID
- NCT05403619
- Acronym / sponsor ID
- eFOCUS / eFOCUS 1
- Conditions
- Shortness of Breath, Acute Respiratory Failure
- Keywords
- Acute decompensated heart failure, Pneumonia, Pulmonary Embolism, Ultrasound
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 119 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 1 Jul 2021 (actual)
- Study completion
- 1 Sep 2021 (actual)
- First posted
- 3 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients | – | Diagnostic Test: Diagnostic testPatients hospitalized for shortness of breath with realization of an enhanced FoCUS |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients hospitalized for acute shortness of breath
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- Comprehensive echocardiography already performed
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diagnostic testAlso: Focused cardiac UltrasoundCardiac Ultrasound in order to explore the causes of shortness of breath | Diagnostic test | Patients |
Primary outcome
Pooled introduction or discontinuation of diuretics, antibiotics or anticoagulants
Time frame: 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
1 secondary outcome
Changes of diagnostic categories associated with eFOCUS
Time frame: up to 24 hours after eFoCUS
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Shortness of Breath and Acute Respiratory Failure, run by Nantes University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pooled introduction or discontinuation of diuretics, antibiotics or anticoagulants (time frame: up to 24 hours after eFoCUS). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2022.