Dyspnea; CardiacLUSNCT05126940
Bedside Lung Ultrasonography by Nurses in Acute Dyspnea.
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 years and older
- Conditions the study is for
- Dyspnea; Cardiac
- What is being tested?
- we perform a lung ultrasound to all the patients admitted for dyspnea independantly from the final diagnosis
- How many people
- 216 participants
- Where
- 1 siteTunisia
- Study dates
- 1 Jan 2018to 31 Jan 2019
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: A convenience sampling approach, including all patients admitted to the ED for acute dyspnea as chief complaint, was used.
Who may be able to join
- non traumatic dyspnea with the final diagnosis of heart failure
Who cannot join
- age less than 18 years
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Bedside Lung Ultrasonography by Emergency Department Nurses as an Aid for Identifying Heart Failure in Patients With Acute 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 nurses.
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.
the study aimed to evaluate the accuracy and reproducibility of B-lines testing assessed by emergency nurses after 12-h training in the diagnosis of HF in patients admitted to the emergency department with acute dyspnea.
- Conditions
- Dyspnea; Cardiac
- Being tested
- we perform a lung ultrasound to all the patients admitted for dyspnea independantly from the final diagnosis
- Keywords
- Lung ultrasound, heart failure, diagnosis, accuracy, nurses
- 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.
we perform a lung ultrasound to all the patients admitted for dyspnea independantly from the final diagnosisDiagnostic test
Also called lus
Patients were placed in a semi-recumbent or supine position depending on their respiratory tolerance. For each side of the chest, 4 zones have to be assessed : 2 anterior and 2 lateral. The operator should calculate the number of B-lines when present .
| Study group | Role | What they receive |
|---|---|---|
| nurses | ED nurses trained to perform LUS and blinded to the final diagnosis Receives: Diagnostic Test: we perform a lung ultrasound to all the patients admitted for dyspnea independantly from the final diagnosis | |
| emergency physician | certified emergency physician who had accomplished a full mentoring program for "Ultra-Sound Life Support". Receives: Diagnostic Test: we perform a lung ultrasound to all the patients admitted for dyspnea independantly from the final diagnosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
the accuracy of LUS performed by nurses in the diagnosis of heart failure
the accuracy of LUS in the diagnosis of heart failure measured by sensitivity .
Measured: 0 days
the Specificity of LUS by nurses in the diagnosis of heart failure
the accuracy of LUS in the diagnosis of heart failure measured by specificity.
Measured: 0 days
the reproducibility of LUS in by nurses the diagnosis of heart failure
the accuracy of LUS in the diagnosis of heart failure measured by area under the roc curve
Measured: 0 days
Agreement between nurses and expert's
Agreement between nurses and expert's interpretation was assessed by kappa agreement index for ordinal LUS scale classification
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 posted19 Nov 2021
- Study start1 Jan 2018
- Primary completion31 Jan 2019
- Study completion31 Jan 2019
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
- 216 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05126940
- Sponsor's protocol ID
- LR12SP18
- Acronym
- LUS
- Status last verified
- Nov 2021
- First submitted
- 29 Sep 2021
- Last updated
- 19 Nov 2021
- 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 19 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bedside Lung Ultrasonography by Emergency Department Nurses as an Aid for Identifying Heart Failure in Patients With Acute Dyspnea
- ClinicalTrials.gov ID
- NCT05126940
- Acronym / sponsor ID
- LUS / LR12SP18
- Conditions
- Dyspnea; Cardiac
- Keywords
- Lung ultrasound, heart failure, diagnosis, accuracy, nurses
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 216 participants (actual)
- Lead sponsor
- University of MonastirUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 31 Jan 2019 (actual)
- Study completion
- 31 Jan 2019 (actual)
- First posted
- 19 Nov 2021 (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 nurses.
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.
the study aimed to evaluate the accuracy and reproducibility of B-lines testing assessed by emergency nurses after 12-h training in the diagnosis of HF in patients admitted to the emergency department with acute dyspnea.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| nurses | – | Diagnostic Test: we perform a lung ultrasound to all the patients admitted for dyspnea independantly from the final diagnosisED nurses trained to perform LUS and blinded to the final diagnosis |
| emergency physician | – | Diagnostic Test: we perform a lung ultrasound to all the patients admitted for dyspnea independantly from the final diagnosiscertified emergency physician who had accomplished a full mentoring program for "Ultra-Sound Life Support". |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A convenience sampling approach, including all patients admitted to the ED for acute dyspnea as chief complaint, was used.
Key inclusion criteria (1 listed)
- non traumatic dyspnea with the final diagnosis of heart failure
Key exclusion criteria (6 listed)
- age less than 18 years
- impossibility to give consent to participate in the study
- post-traumatic dyspnea
- pregnant women
- need for endotracheal intubation or inotropic drugs
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 |
|---|---|---|
| we perform a lung ultrasound to all the patients admitted for dyspnea independantly from the final diagnosisAlso: lusPatients were placed in a semi-recumbent or supine position depending on their respiratory tolerance. For each side of the chest, 4 zones have to be assessed : 2 anterior and 2 lateral. The operator should calculate the number of B-lines when present . | Diagnostic test | emergency physician, nurses |
Primary outcome
the accuracy of LUS performed by nurses in the diagnosis of heart failure
Time frame: 0 days
the accuracy of LUS in the diagnosis of heart failure measured by sensitivity .
the Specificity of LUS by nurses in the diagnosis of heart failure
Time frame: 0 days
the accuracy of LUS in the diagnosis of heart failure measured by specificity.
the reproducibility of LUS in by nurses the diagnosis of heart failure
Time frame: 0 days
the accuracy of LUS in the diagnosis of heart failure measured by area under the roc curve
Agreement between nurses and expert's
Time frame: 0 days
Agreement between nurses and expert's interpretation was assessed by kappa agreement index for ordinal LUS scale classification
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 19 Nov 2021.
- Individual participant dataSharing planned: Undecided
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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 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 6 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 19 Nov 2021. 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 performed by nurses in the diagnosis of heart failure (time frame: 0 days). The study lists 4 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 19 Nov 2021.