Ignite Creation Date:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2025-12-26 @ 12:05 AM
Study NCT ID:
NCT00192894
Status:
COMPLETED
Last Update Posted:
2025-04-04
First Post:
2005-09-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
New Methods to Detect a Decrease in Heart Function
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-05-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2005-03-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-01', 'studyFirstSubmitDate': '2005-09-12', 'studyFirstSubmitQcDate': '2005-09-12', 'lastUpdatePostDateStruct': {'date': '2025-04-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2005-09-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-03-15', 'type': 'ACTUAL'}}, 'conditionsModule': {'conditions': ['Orthopedic Surgery']}, 'descriptionModule': {'briefSummary': 'The purpose of this study was to evaluate the changes in heart function during onset of spinal anesthesia using a new and less invasive method, the LidcoTMplus.', 'detailedDescription': 'The incidence of hypotension during onset of spinal anesthesia in elderly patients varies from 27% to 80% depending on which definition being used. Studies of cardiac output (CO) has shown that it is maintained or only slightly decreased .\n\nUnfortunately, the time-resolution in these studies is often several minutes, and the description of changes is consequently often a start-to-end relation rather than a description of the dynamic changes during onset of spinal anesthesia.\n\nA recent advance in measuring CO is the LiDCOTMplus hemodynamic monitor, which has proved reliable compared to pulmonary artery catheters in various intensive care settings. This monitor allows for beat-to-beat measuring during various procedures and thus early warning of hemodynamic events.\n\nAnother method with potential for early warning of decreased perfusion is near-infrared spectroscopy (NIRS). NIRS is used for continuous and non-invasive monitoring of cerebral oxygen saturation (ScO2) and even a small reduction has recently shown to predict maternal hypotension during caesarian section.\n\nThe aim of our study was to describe the changes in CO during onset of spinal anesthesia in elderly patients using a method with high time-resolution. We also attempted to evaluate NIRS as predictor of hemodynamic events.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '60 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Elderly patients undergoing spinal anaesthesia', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 60 years or older\n* Elective orthopedic or plastic lower limp surgery\n* in spinal anesthesia\n\nExclusion Criteria:\n\n* Body weight \\<40 kg\n* Currently in treatment with lithium\n* Evidence of aortic valve regurgitation'}, 'identificationModule': {'nctId': 'NCT00192894', 'briefTitle': 'New Methods to Detect a Decrease in Heart Function', 'organization': {'class': 'OTHER', 'fullName': 'Rigshospitalet, Denmark'}, 'officialTitle': 'Cardiac Output Changes During Onset of Spinal Anesthesia in Elderly Patients', 'orgStudyIdInfo': {'id': '22-04-0019'}}, 'contactsLocationsModule': {'locations': [{'zip': '2100', 'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'Department of anaesthesia, 4231, Center of Head and Orthopaedics, Copenhagen University Hospital, Rigshospitalet', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}], 'overallOfficials': [{'name': 'Lars S. Rasmussen, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Department of anaesthesia, 4231, Center of Head and Orthopaedics, Copenhagen University Hospital, Rigshospitalet'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rigshospitalet, Denmark', 'class': 'OTHER'}, 'collaborators': [{'name': 'The Danish Medical Research Council', 'class': 'OTHER'}, {'name': 'Oberstinde Kirsten Jensa la Cours Foundation', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, Principal Investigator', 'investigatorFullName': 'Lars S. Rasmussen', 'investigatorAffiliation': 'Rigshospitalet, Denmark'}}}}