- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05126940
Bedside Lung Ultrasonography by Nurses in Acute Dyspnea. (LUS)
Bedside Lung Ultrasonography by Emergency Department Nurses as an Aid for Identifying Heart Failure in Patients With Acute Dyspnea
Study Overview
Status
Conditions
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Monastir, Tunisia, 5000
- Nouira Semir
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- non traumatic dyspnea with the final diagnosis of heart failure
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
nurses
ED nurses trained to perform LUS and blinded to the final diagnosis
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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 .
Other Names:
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emergency physician
certified emergency physician who had accomplished a full mentoring program for "Ultra-Sound Life Support".
|
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 .
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
the accuracy of LUS performed by nurses in the diagnosis of heart failure
Time Frame: 0 days
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the accuracy of LUS in the diagnosis of heart failure measured by sensitivity .
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0 days
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the Specificity of LUS by nurses in the diagnosis of heart failure
Time Frame: 0 days
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the accuracy of LUS in the diagnosis of heart failure measured by specificity.
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0 days
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the reproducibility of LUS in by nurses the diagnosis of heart failure
Time Frame: 0 days
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the accuracy of LUS in the diagnosis of heart failure measured by area under the roc curve
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0 days
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Agreement between nurses and expert's
Time Frame: 0 days
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Agreement between nurses and expert's interpretation was assessed by kappa agreement index for ordinal LUS scale classification
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0 days
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- LR12SP18
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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