Ignite Creation Date:
2025-12-24 @ 10:39 PM
Ignite Modification Date:
2025-12-25 @ 8:10 PM
Study NCT ID:
NCT06033235
Status:
COMPLETED
Last Update Posted:
2025-05-08
First Post:
2023-09-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Computed Tomography Scanning in ICU
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D014057', 'term': 'Tomography, X-Ray Computed'}], 'ancestors': [{'id': 'D007090', 'term': 'Image Interpretation, Computer-Assisted'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011856', 'term': 'Radiographic Image Enhancement'}, {'id': 'D007089', 'term': 'Image Enhancement'}, {'id': 'D010781', 'term': 'Photography'}, {'id': 'D011859', 'term': 'Radiography'}, {'id': 'D014056', 'term': 'Tomography, X-Ray'}, {'id': 'D014054', 'term': 'Tomography'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2025-05-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-07', 'studyFirstSubmitDate': '2023-09-05', 'studyFirstSubmitQcDate': '2023-09-05', 'lastUpdatePostDateStruct': {'date': '2025-05-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-09-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in diagnosis and/or patient management', 'timeFrame': '3 years', 'description': "To examine in what percentage of the CT examinations the examination contributed to a significant progress in the diagnosis or a significant change in the patient's treatment plan, while referring to subgroups of patients in the intensive care unit."}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['CT Scans in the Intensive Care Unit']}, 'descriptionModule': {'briefSummary': 'Patients admitted to the intensive care unit often require CT imaging. Performing this diagnostic test on a critically ill patient involves risks, such as those associated with transferring a ventilated and unstable patient and those associated with the injection of intravenous contrast material. Also, multiple CT examinations may create a burden on the X-ray institute and the medical staff, result in the postponement of CT examinations for other patients, as well as increase hospitalization costs.\n\nIn this work, we would like to check the rate of complications involved in performing a CT scan in patients hospitalized in the general intensive care unit of our institution, while analyzing the differences between the times the test is performed (morning, night shift), as well as examine in what percentage of the CT scans the test performed contributed to a significant progress in the diagnosis or a significant change in the treatment plan of the patient, while referring to subgroups (sepsis, trauma, respiratory failure, with an emphasis on covid patients, patients with scoliosis, patients with intracranial pathology).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients who underwent CT examinations during hospitalization in the intensive care unit for any etiology, from January 2020 to January 2023.\n\n\\-', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:All patients who underwent CT examinations during hospitalization in the intensive care unit for any etiology, from January 2020 to January 2023.\n\n\\-\n\nExclusion Criteria:Patients who did not meet the above criteria or for whom data were missing.\n\n\\-'}, 'identificationModule': {'nctId': 'NCT06033235', 'briefTitle': 'Computed Tomography Scanning in ICU', 'organization': {'class': 'OTHER', 'fullName': 'Meir Medical Center'}, 'officialTitle': 'Impact of Computed Tomography Scanning on ICU Patient Management: Retrospective Study', 'orgStudyIdInfo': {'id': '0220-23-MMC'}}, 'armsInterventionsModule': {'interventions': [{'name': 'CT scan in critically ill patients in the intensive care unit', 'type': 'DIAGNOSTIC_TEST', 'description': 'CT scan in critically ill patients in the intensive care unit'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Kfar Saba', 'country': 'Israel', 'facility': 'Meir Medical Center', 'geoPoint': {'lat': 32.175, 'lon': 34.90694}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Meir Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr', 'investigatorFullName': 'sara dichtwald', 'investigatorAffiliation': 'Meir Medical Center'}}}}