Ignite Creation Date:
2025-12-24 @ 3:22 PM
Ignite Modification Date:
2026-02-20 @ 12:45 PM
Study NCT ID:
NCT03660592
Status:
COMPLETED
Last Update Posted:
2022-03-17
First Post:
2018-07-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Contribution and Reproducibility of Lung Ultrasound in the Diagnosis of Acute Heart Failure in the ED
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004417', 'term': 'Dyspnea'}, {'id': 'D006333', 'term': 'Heart Failure'}, {'id': 'D004194', 'term': 'Disease'}], 'ancestors': [{'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1024}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2017-01-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-03-16', 'studyFirstSubmitDate': '2018-07-06', 'studyFirstSubmitQcDate': '2018-09-05', 'lastUpdatePostDateStruct': {'date': '2022-03-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-09-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the reproductibility of LUS in the diagnosis of heart failure', 'timeFrame': '0 days', 'description': 'the reproductibility of the LUS in the diagnosis of heart failure between two different operators (using the Kappa and the agreement index)'}, {'measure': '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', 'timeFrame': '0 days', 'description': 'the accuracy of LUS in the diagnosis of heart failure measured by sensitivity ,specificity, and area under the roc curve'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Lung ultrasound', 'heart failure', 'diagnosis'], 'conditions': ['Dyspnea; Cardiac']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.urgencemonastir.com', 'label': 'official department website'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nLung ultrasonography is becoming a standard tool in critical cases in the ED.\n\nthe 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.\n\nThree 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.\n\nThis 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.\n\nPatients 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.\n\nAHF was determined on the base of clinical exam, chest x-ray , brain natriuretic peptide (BNP) and echocardiographic findings.\n\nA patient lung comet score (LCS) was obtained by summing the number of comets in each of the scanned spaces.\n\nThen the probability of AHF was defined as :\n\nlow probability (LCS\\<15) intermediate probability (15 \\<LCS\\<30), and high probability (LCS\\>30 ).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'all patients admitted to the ED with acute dyspnea, with the final diagnosis of heart failure', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* non traumatic dyspnea with the final diagnosis of heart failure\n\nExclusion Criteria:\n\n* impossibility to give consent to participate in the study\n* post traumatic dyspnea\n* pregnant women\n* need for endotracheal intubation or inotropic drugs\n* patients who were deemed too unstable for sonography by the treating team'}, 'identificationModule': {'nctId': 'NCT03660592', 'briefTitle': 'Contribution and Reproducibility of Lung Ultrasound in the Diagnosis of Acute Heart Failure in the ED', 'organization': {'class': 'OTHER', 'fullName': 'University of Monastir'}, 'officialTitle': 'Contribution LUS and Reproducibility of Lung Ultrasound in the Diagnosis of Acute Heart Failure in the Emergency Department (ED)', 'orgStudyIdInfo': {'id': 'LUS/HF'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'operator 1', 'description': 'ED resident experimented in pulmonary ultrasonography and blinded to the final diagnosis'}, {'label': 'operator 2', 'description': 'a different ED resident experimented in pulmonary ultrasonography and blinded to the final diagnosis'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Nouira semir, professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'university of ùmonastir'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Monastir', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Pr Nouira Semir', 'investigatorFullName': 'Pr. Semir Nouira', 'investigatorAffiliation': 'University of Monastir'}}}}