Dyspnea; CardiacNCT03660592
Contribution and Reproducibility of Lung Ultrasound in the Diagnosis of Acute Heart Failure in the ED
An observational study of Dyspnea; Cardiac, run by University of Monastir.
Trial summary
Discrimination between cardiac and non-cardiac causes of dyspnea can be challenging, causing excessive delay before adequate therapy. In clinical practice lung ultrasound (LUS) is becoming an easy and reliable noninvasive tool for the evaluation of dyspnea and can shorten the time to diagnosis .However the… Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Dyspnea; Cardiac
- How many people
- 1,024 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2016to 1 Jan 2017
- 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 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: all patients admitted to the ED with acute dyspnea, with the final diagnosis of heart failure
Who may be able to join
- non traumatic dyspnea with the final diagnosis of heart failure
Who cannot join
- impossibility to give consent to participate in the study
- post traumatic dyspnea
- pregnant women
- need for endotracheal intubation or inotropic drugs
- patients who were deemed too unstable for sonography by the treating team
About this study
Official title: Contribution LUS and Reproducibility of Lung Ultrasound in the Diagnosis of Acute Heart Failure in the Emergency Department (ED)
Discrimination between cardiac and non-cardiac causes of dyspnea can be challenging, causing excessive delay before adequate therapy. In clinical practice lung ultrasound (LUS) is becoming an easy and reliable noninvasive tool for the evaluation of dyspnea and can shorten the time to diagnosis .However the reproductibility of this test was not extensively studied.
Read the detailed description
Dyspnea is one of the most distressing situations for the patient . Emergency cases do not always present in conditions that are ideal for immediate diagnosis, which sometimes compromises outcome. Physical examination, laboratory findings and radiography are imperfect, resulting in a need for sophisticated test results that delay management.
Lung ultrasonography is becoming a standard tool in critical cases in the ED.
the investigators aim to perform ultrasonography on consecutive patients admitted to the ICU with dyspnea, comparing lung ultrasonography results on initial presentation with the final diagnosis by the ICU team.
Three items were assessed: artifacts (horizontal A lines or vertical B lines indicating interstitial syndrome), lung sliding, and alveolar consolidation and/or pleural effusion, these items were grouped to assess ultrasound profiles.
This study assesses the potential of lung ultrasonography to diagnose heart failure.The second aim of this study was to evaluate the inter-observer reproducibility of LUS performed by ED residents in the evaluation of cardiac causes of acute dyspnea.
Patients presenting to the ED with acute dyspnea will be prospectively enrolled in this study. In each patient, LUS was performed by two ED residents blinded to clinical diagnoses.
AHF was determined on the base of clinical exam, chest x-ray , brain natriuretic peptide (BNP) and echocardiographic findings.
A patient lung comet score (LCS) was obtained by summing the number of comets in each of the scanned spaces.
Then the probability of AHF was defined as :
low probability (LCS<15) intermediate probability (15 <LCS<30), and high probability (LCS>30 ).
- Conditions
- Dyspnea; Cardiac
- Keywords
- Lung ultrasound, heart failure, diagnosis
- Medical subject headings
- Dyspnea, Heart Failure, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| operator 1 | ED resident experimented in pulmonary ultrasonography and blinded to the final diagnosis | |
| operator 2 | a different ED resident experimented in pulmonary ultrasonography and blinded to the final diagnosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
the reproductibility of LUS in the diagnosis of heart failure
the reproductibility of the LUS in the diagnosis of heart failure between two different operators (using the Kappa and the agreement index)
Measured: 0 days
the accuracy of LUS in the diagnosis of heart failure the accuracy of LUS in the diagnosis of heart failure measured by sensitivity ,specificity, and area under the roc curve
the accuracy of LUS in the diagnosis of heart failure measured by sensitivity ,specificity, and area under the roc curve
Measured: 0 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2018
- Study start1 Oct 2016
- Primary completion1 Jan 2017
- Study completion1 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dyspnea; CardiacStudies of the same condition, open and under way.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 1,024 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Monastir
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pr. Semir Nouira, University of Monastir
- Investigators
- Nouira semir, professor, Principal investigator, university of ùmonastir
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03660592
- Sponsor's protocol ID
- LUS/HF
- Status last verified
- Mar 2022
- First submitted
- 6 Jul 2018
- Last updated
- 17 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contribution LUS and Reproducibility of Lung Ultrasound in the Diagnosis of Acute Heart Failure in the Emergency Department (ED)
- ClinicalTrials.gov ID
- NCT03660592
- Acronym / sponsor ID
- LUS/HF
- Conditions
- Dyspnea; Cardiac
- Keywords
- Lung ultrasound, heart failure, diagnosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,024 participants (actual)
- Lead sponsor
- University of MonastirUniversity, hospital or other
- Study start
- 1 Oct 2016 (actual)
- Primary completion
- 1 Jan 2017 (actual)
- Study completion
- 1 Jan 2017 (actual)
- First posted
- 6 Sep 2018 (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.
Discrimination between cardiac and non-cardiac causes of dyspnea can be challenging, causing excessive delay before adequate therapy. In clinical practice lung ultrasound (LUS) is becoming an easy and reliable noninvasive tool for the evaluation of dyspnea and can shorten the time to diagnosis .However the reproductibility of this test was not extensively studied.
Detailed description
Dyspnea is one of the most distressing situations for the patient . Emergency cases do not always present in conditions that are ideal for immediate diagnosis, which sometimes compromises outcome. Physical examination, laboratory findings and radiography are imperfect, resulting in a need for sophisticated test results that delay management.
Lung ultrasonography is becoming a standard tool in critical cases in the ED.
the investigators aim to perform ultrasonography on consecutive patients admitted to the ICU with dyspnea, comparing lung ultrasonography results on initial presentation with the final diagnosis by the ICU team.
Three items were assessed: artifacts (horizontal A lines or vertical B lines indicating interstitial syndrome), lung sliding, and alveolar consolidation and/or pleural effusion, these items were grouped to assess ultrasound profiles.
This study assesses the potential of lung ultrasonography to diagnose heart failure.The second aim of this study was to evaluate the inter-observer reproducibility of LUS performed by ED residents in the evaluation of cardiac causes of acute dyspnea.
Patients presenting to the ED with acute dyspnea will be prospectively enrolled in this study. In each patient, LUS was performed by two ED residents blinded to clinical diagnoses.
AHF was determined on the base of clinical exam, chest x-ray , brain natriuretic peptide (BNP) and echocardiographic findings.
A patient lung comet score (LCS) was obtained by summing the number of comets in each of the scanned spaces.
Then the probability of AHF was defined as :
low probability (LCS<15) intermediate probability (15 <LCS<30), and high probability (LCS>30 ).
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| operator 1 | – | –ED resident experimented in pulmonary ultrasonography and blinded to the final diagnosis |
| operator 2 | – | –a different ED resident experimented in pulmonary ultrasonography and blinded to the final diagnosis |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- all patients admitted to the ED with acute dyspnea, with the final diagnosis of heart failure
Key inclusion criteria (1 listed)
- non traumatic dyspnea with the final diagnosis of heart failure
Key exclusion criteria (5 listed)
- impossibility to give consent to participate in the study
- post traumatic dyspnea
- pregnant women
- need for endotracheal intubation or inotropic drugs
- patients who were deemed too unstable for sonography by the treating team
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
the reproductibility of LUS in the diagnosis of heart failure
Time frame: 0 days
the reproductibility of the LUS in the diagnosis of heart failure between two different operators (using the Kappa and the agreement index)
the accuracy of LUS in the diagnosis of heart failure the accuracy of LUS in the diagnosis of heart failure measured by sensitivity ,specificity, and area under the roc curve
Time frame: 0 days
the accuracy of LUS in the diagnosis of heart failure measured by sensitivity ,specificity, and area under the roc curve
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 17 Mar 2022.
- official department websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
Related trials for Dyspnea; Cardiac
Recruiting
Effect of Box Breathing Before Chest Tube Removal After Open-Heart Surgery
Open-Heart Surgery
Recruiting
Evaluation of Fibroscan® Performance in Diagnosing Acute Heart Failure in Patients Presenting to the Emergency Department
Acute Heart Failure (AHF)
Not yet recruiting
Head-to-Head (H2H) Comparison of Ambulatory Cardiac ECG Monitors in Japan
Atrial Fibrillation (AF), Atrial Flutter
Recruiting
Low Level Tragus Stimulation in Acute Decompensated Heart Failure
Acute Decompensated Heart Failure
RecruitingObservational study
Evaluation of the Effectiveness of the Cardiostory Device in Distinguishing Heart Failure From Other Causes in Patients Presenting With Dyspnea.
Heart Failure, Dyspnea
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.
Nouira semir, professor principal investigator
university of ùmonastir
Questions about this trial
What is this clinical trial studying?
An observational study of Dyspnea; Cardiac, run by University of Monastir.
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 1 inclusion and 5 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 17 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
the reproductibility of LUS in the diagnosis of heart failure (time frame: 0 days). The study lists 2 primary outcomes in all. 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 17 Mar 2022.