Dyspnea; CardiacNCT03717779
Contribution LUS in the Diagnosis of Acute Heart Failure (AHF) in Patients Admitted to the ED
An observational study of Dyspnea; Cardiac, run by University of Monastir at 1 site in Tunisia.
Trial summary
This study assesses the potential of lung ultrasonography to diagnose heart failure. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Dyspnea; Cardiac
- What is being tested?
- lung ultrasound
- How many people
- 600 participants
- Where
- 1 siteTunisia
- Study dates
- 2 Jan 2016to 1 Oct 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
- Adult, Older adult
Study population: all patients admitted to the ED with acute dyspnea, with the final diagnosis of heart failure by the ICU team
Who may be able to join
- non traumatic dyspnea with the final diagnosis of heart failure
Who cannot join
- coma,
- shock,Mechanical Ventilation,
- vasopressor drugs
- arrhythmia serious and sustained,
- non consent
Trial locations and contacts
1 site in 1 country.
Tunisia1 site
Emergency department of university hospital Fattouma Bourguiba of Monastir
Monastir, 5000
About this study
Official title: Contribution of Pulmonary Ultrasonography in the Diagnosis of Acute Heart Failure (AHF) in Patients Admitted to Emergency Department (ED) for Dyspnea
This study assesses the potential of lung ultrasonography to diagnose heart failure.
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.
- Conditions
- Dyspnea; Cardiac
- Being tested
- lung ultrasound
- Keywords
- Lung ultrasound,, heart failure, diagnosis, accuracy
- 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.
lung ultrasoundDiagnostic test
we perform a lung ultrasound to all the patients admitted for dyspnea independantly from the final diagnosis
| Study group | Role | What they receive |
|---|---|---|
| HF/HFpEF | patients with heart failure with a preserved ejection fraction(HFpEF) perform LUS Receives: Diagnostic Test: lung ultrasound | |
| HF/HFrEF | patients with heart failure with a reduced ejection fraction(HFrEF) perform LUS Receives: Diagnostic Test: lung ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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 posted24 Oct 2018
- Study start2 Jan 2016
- Primary completion1 Oct 2017
- Study completion1 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 600 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, PHD, Principal investigator, University hospital of Monastir
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03717779
- Sponsor's protocol ID
- Lung Ultra Sound (LUS)
- Status last verified
- Jan 2019
- First submitted
- 6 Jul 2018
- Last updated
- 16 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Msolli MA, Sekma A, Marzouk MB, Chaabane W, Bel Haj Ali K, Boukadida L, Bzeouich N, Gannoun I, Trabelssi I, Laaouiti K, Grissa MH, Beltaief K, Dridi Z, Belguith A, Methamem M, Bouida W, Boukef R, Boubaker H, Nouira S; GREAT Network. Bedside lung ultrasonography by emergency department residents as an aid for identifying heart failure in patients with acute dyspnea after a 2-h training course. Ultrasound J. 2021 Feb 9;13(1):5. doi: 10.1186/s13089-021-00207-9.
PubMed 33559777
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contribution of Pulmonary Ultrasonography in the Diagnosis of Acute Heart Failure (AHF) in Patients Admitted to Emergency Department (ED) for Dyspnea
- ClinicalTrials.gov ID
- NCT03717779
- Acronym / sponsor ID
- Lung Ultra Sound (LUS)
- Conditions
- Dyspnea; Cardiac
- Keywords
- Lung ultrasound,, heart failure, diagnosis, accuracy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- University of MonastirUniversity, hospital or other
- Study start
- 2 Jan 2016 (actual)
- Primary completion
- 1 Oct 2017 (actual)
- Study completion
- 1 Oct 2017 (actual)
- First posted
- 24 Oct 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.
This study assesses the potential of lung ultrasonography to diagnose heart failure.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HF/HFpEF | – | Diagnostic Test: lung ultrasoundpatients with heart failure with a preserved ejection fraction(HFpEF) perform LUS |
| HF/HFrEF | – | Diagnostic Test: lung ultrasoundpatients with heart failure with a reduced ejection fraction(HFrEF) perform LUS |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- all patients admitted to the ED with acute dyspnea, with the final diagnosis of heart failure by the ICU team
Key inclusion criteria (1 listed)
- non traumatic dyspnea with the final diagnosis of heart failure
Key exclusion criteria (5 listed)
- coma,
- shock,Mechanical Ventilation,
- vasopressor drugs
- arrhythmia serious and sustained,
- non consent
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 |
|---|---|---|
| lung ultrasoundwe perform a lung ultrasound to all the patients admitted for dyspnea independantly from the final diagnosis | Diagnostic test | HF/HFpEF, HF/HFrEF |
Primary outcome
the accuracy of LUS in the diagnosis of heart failure
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 16 Jan 2019.
- Derived from this study: PubMed 33559777Msolli MA, Sekma A, Marzouk MB, Chaabane W, Bel Haj Ali K, Boukadida L, Bzeouich N, Gannoun I, Trabelssi I, Laaouiti K, Grissa MH, Beltaief K, Dridi Z, Belguith A, Methamem M, Bouida W, Boukef R, Boubaker H, Nouira S; GREAT Network. Bedside lung ultrasonography by emergency department residents as an aid for identifying heart failure in patients with acute dyspnea after a 2-h training course. Ultrasound J. 2021 Feb 9;13(1):5. doi: 10.1186/s13089-021-00207-9.
- 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, PHD principal investigator
University hospital of Monastir
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 Dyspnea; Cardiac, run by University of Monastir at 1 site in Tunisia.
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 16 Jan 2019. 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 Tunisia. 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?
the accuracy of LUS in the diagnosis of heart failure (time frame: 0 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03717779, which also lists 1 linked publication.
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 16 Jan 2019.