Ignite Creation Date:
2025-12-25 @ 2:28 AM
Ignite Modification Date:
2026-01-24 @ 1:46 PM
Study NCT ID:
NCT06591234
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-09-19
First Post:
2024-09-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Reliability of Internal Jugular Ultrasound : an Observational Transversal Study Conducted Using Images Registered From Patients (AIJV-I)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004487', 'term': 'Edema'}, {'id': 'D020896', 'term': 'Hypovolemia'}], 'ancestors': [{'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-09-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-09-07', 'studyFirstSubmitDate': '2024-09-07', 'studyFirstSubmitQcDate': '2024-09-07', 'lastUpdatePostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Inter-rater reliability of Internal Jugular Vein Ultrasound measures', 'timeFrame': 'From enrollment to the end of recording (within 2 months of starting the study)', 'description': 'We will measure the variability in recording, among 8 sonographers, of 4 Ultrasound measures of Internal Jugular Vein : the antero-posterior diameters, the area, the aspect ratio and the collapsibility index'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['reliability', 'internal jugular vein', 'ultrasound'], 'conditions': ['Hypervolemia', 'Hypovolemia']}, 'referencesModule': {'availIpds': [{'url': 'https://www.ausl.bologna.it/', 'type': 'Study Protocol', 'comment': 'To send a request by mail'}], 'seeAlsoLinks': [{'url': 'https://www.ausl.bologna.it/', 'label': 'Thelink of the Hospital of PI'}]}, 'descriptionModule': {'briefSummary': 'The goal of this observational study is to test the inter-rater reliability among a group of ultrasound measurements of internal jugular vein using a group of images, registered in several acoustic views of neck of patients admitted in Medicine Department.\n\nThe main questions it aims to answer is: are there differences in recording echographic measurements of the internal jugular vein between different sonographers ?', 'detailedDescription': "Dear Mrs/s, We intend to carry out medical scientific research in this Centre. It is a study of observation.. This study aims to measure the reliability (variability in recording measurements between two or more operators) of a new method, the ultrasound of a vein in the neck, called the internal jugular vein. This method could be used to better assess congestion (accumulation of fluid in the lung or tissues: vessels and skin) or lack of fluid in the veins, both possible causes of hospitalization.\n\nWe are proposing to you to participate in this study because you are hospitalized in the ward and this method allows to understand, together with other elements, the state of \\"volemia\\" (the amount of liquids present in your veins).\n\nWe decided to carry out this study because we would like to verify if the ultrasound of the internal jugular vein is reliable, that is it can be used by several operators without variations in the measurements . This would allow, after further studies, to use it in clinical practice for the management of people who may need fluid infusion or therapies to increase fluid removal.\n\nThe study aims to evaluate the reliability (variability in recording measurements between two or more operators) of ultrasound of a vein of the neck, called internal jugular vein In particular we would like to understand if there is a variability in the execution of the ultrasound of the jugular vein between several operators- doctors simultaneously to the same patient. In fact, this method is not currently used in current clinical practice, but if we demonstrate that it is reliable (ie more operators record the same measurements on the same patient , without variations), after further confirmation studies have been conducted , could be used in clinical practice. Its use could, in our view, improve the management of many situations, as it would allow doctors to understand whether the person examined is suffering from \\"congestion\\", that is, accumulation of water in the lungs and tissues or lack of fluids. This would allow the doctor to take appropriate therapies to reduce congestion or increase fluid.\n\nDuring the hospitalization, on one occasion, will be submitted to an ultrasound examination of the neck on the right , simultaneously by two or three operators (doctors) . Each operator's examination should take about 10-15 minutes. So the time you spend on it should be 20-30 minutes. The examination will be carried out in bed, in his room with the back tilted 45 degrees and the neck slightly turned to the left.\n\nThe necessary treatment and examinations will be carried out and the reason for his admission will be continued.\n\nThere is no health risk, as ultrasound is a non-invasive examination based on ultrasound. The only discomfort is to be subjected for about thirty minutes to two or three consecutive examinations. There are no direct benefits to the participants. The study is oriented towards acquiring more scientific knowledge."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'We will include 2 populations:\n\nPatients admitted , for any causes, to the Medicine Department (we will record a group of 6 images that will be used by the sonographers).\n\nSonographers from Medicine Department', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients, admitted to the Medicine Department of Hospital Maggiore in Bologna and eight expert sonographers\n\nExclusion Criteria:\n\n* impossibility in providing consent, presence of central venous catheter in the internal jugular vein, thrombosis of the vein'}, 'identificationModule': {'nctId': 'NCT06591234', 'acronym': 'AIJV-I', 'briefTitle': 'Reliability of Internal Jugular Ultrasound : an Observational Transversal Study Conducted Using Images Registered From Patients (AIJV-I)', 'organization': {'class': 'OTHER', 'fullName': 'Maggiore Bellaria Hospital, Bologna'}, 'officialTitle': 'A Multicenter Study on the Reliability of Four Ultrasound Measures : the Antero-posterior Diameter , the End-exipratory Area , the Aspect Ratio and the Collapsibility Index of Internal Jugular Vein Evaluated on Images Recorded From Patients Admitted to Four Medicine Departments', 'orgStudyIdInfo': {'id': '725-2023-OSS-AUSLBObis'}}, 'contactsLocationsModule': {'locations': [{'zip': '40125', 'city': 'Bologna', 'country': 'Italy', 'facility': 'Hospital Maggiore', 'geoPoint': {'lat': 44.49381, 'lon': 11.33875}}], 'overallOfficials': [{'name': 'Nicola Parenti, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medicina Interna Hospital Maggiore Bologna'}]}, 'ipdSharingStatementModule': {'url': 'https://docs.google.com/document/d/10aop9iAeTrVKNpiofbG017R3AYAlCfFHVa0HPs6Y-00/edit?usp=sharing', 'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'Beginning 3 months and ending 3 years after the publication of results', 'ipdSharing': 'YES', 'description': 'I will share the study protocol.', 'accessCriteria': 'The criteria that must be met in order for data to be shared are:\n\nClinical Researchers who conduct independent research Analyses on diagnostic accuracy of ultrasound methods Statistical methods for those analyses must be not approved by independent review.\n\nA proposal that describes planned analyses must be submitted and a data sharing agreement must be signed.\n\nThose documents can be submitted by sending a mail to nicola.parenti@ausl.bologna.it'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Maggiore Bellaria Hospital, Bologna', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Nicola Parenti', 'investigatorAffiliation': 'Maggiore Bellaria Hospital, Bologna'}}}}