Ignite Creation Date:
2025-12-25 @ 2:18 AM
Ignite Modification Date:
2025-12-27 @ 11:25 PM
Study NCT ID:
NCT04602234
Status:
COMPLETED
Last Update Posted:
2020-10-26
First Post:
2020-10-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Diagnostic of Lower Respiratory Tract Infection by Lung Ultrasonography in General Practice
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Among the 151 patients included, 111 LUS were performed (LUS group)'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 151}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-12-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2020-03-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-10-20', 'studyFirstSubmitDate': '2020-10-20', 'studyFirstSubmitQcDate': '2020-10-20', 'lastUpdatePostDateStruct': {'date': '2020-10-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-10-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diagnosis modification', 'timeFrame': '3 months', 'description': 'Diagnosis modification after lung ultrasonography'}], 'secondaryOutcomes': [{'measure': 'Therapeutic modification', 'timeFrame': '3 months', 'description': 'Therapeutic modification after lung ultrasonography'}, {'measure': 'Imagery prescription', 'timeFrame': '3 months', 'description': 'Decision of imagery prescription after lung ultrasonography'}, {'measure': 'Decision of hospitalization', 'timeFrame': '3 months', 'description': 'Decision of an hospitalization or not after lung ultrasonography'}, {'measure': 'Medical evolution', 'timeFrame': '3 months', 'description': 'Medical evolution at 7 days (improvement, persistence, worsening and hospitalization)'}, {'measure': 'Imagery result', 'timeFrame': '3 months', 'description': 'Result of imagery initially prescribed by general practitioners (Chest CT-Scan or X-Ray)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Lung ultrasonography', 'Lower Respiratory Tract Infection', 'General Practice'], 'conditions': ['Lower Resp Tract Infection', 'Ultrasound Therapy; Complications']}, 'referencesModule': {'references': [{'pmid': '38767949', 'type': 'DERIVED', 'citation': 'Amiot F, Delomas T, Laborne FX, Ecolivet T, Macrez R, Benhamed A. Implementation of lung ultrasonography by general practitioners for lower respiratory tract infections: a feasibility study. Scand J Prim Health Care. 2024 Sep;42(3):463-470. doi: 10.1080/02813432.2024.2343678. Epub 2024 May 20.'}]}, 'descriptionModule': {'briefSummary': 'Lower Respiratory Tract Infection (LRTI) is a frequent motive of consultation in General Practice. Cost, irradiation and availability of traditional imagery make it difficult to perform in every patient with suspected LRTI.\n\nThe objective is to evaluate the performance of LUS realized by family physicians into the usual LRTI diagnostic pathway.\n\nThis study is a prospective, interventional, multi-centric and open study conducted in 3 different centers by 15 General Practitioners (GP) in France. Patient complaining of dyspnea or cough were recruited from December 2019 to March 2020. GP received a training course by LUS expert before the study.\n\nThe primary outcome measure was diagnosis modification after LUS. Secondary measures were therapeutic modification after LUS, decision of imagery prescription after LUS, decision of hospitalization or not after LUS, medical evolution and result of imagery initially prescribed by GP.', 'detailedDescription': 'After an initial medical report, GP\'s concluded to an initial diagnosis and make initial prescription and finally decided or not to perform a standardized eight-points LUS. GP were free to perform or not LUS. If GP decided to perform LUS, GP were allowed to change their diagnosis and prescriptions (LUS group). However, therapeutic changes after LUS could not "downgrade" patient care.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '3 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\> 3 months\n* Dyspnea or cough complaint\n\nExclusion Criteria:\n\n* Age \\< 3 months\n* Rejection to participate to the study'}, 'identificationModule': {'nctId': 'NCT04602234', 'acronym': 'AmbuLUS', 'briefTitle': 'Diagnostic of Lower Respiratory Tract Infection by Lung Ultrasonography in General Practice', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Caen'}, 'officialTitle': 'Diagnosis of Lower Respiratory Tract Infection by Lung Ultrasonography in General Practice : a Prospective, Interventional and Multicentric Study', 'orgStudyIdInfo': {'id': '2019-A00205)52'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'LUS group', 'interventionNames': ['Diagnostic Test: Lung ultrasonography']}, {'type': 'NO_INTERVENTION', 'label': 'No LUS group'}], 'interventions': [{'name': 'Lung ultrasonography', 'type': 'DIAGNOSTIC_TEST', 'description': 'Investigators performed lung ultrasonography on patients', 'armGroupLabels': ['LUS group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14000', 'city': 'Caen', 'state': 'Calvados', 'country': 'France', 'facility': 'University Hospital, Caen', 'geoPoint': {'lat': 49.18585, 'lon': -0.35912}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Caen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}