Ignite Creation Date:
2025-12-24 @ 2:59 PM
Ignite Modification Date:
2026-02-20 @ 6:38 PM
Study NCT ID:
NCT03393559
Status:
COMPLETED
Last Update Posted:
2019-12-27
First Post:
2017-12-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Leg Elevation on Prevention of Intraoperative Hypotension During Beach Chair Position
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002545', 'term': 'Brain Ischemia'}], 'ancestors': [{'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'randomized controlled trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-01-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-12', 'completionDateStruct': {'date': '2019-12-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-12-26', 'studyFirstSubmitDate': '2017-12-26', 'studyFirstSubmitQcDate': '2018-01-05', 'lastUpdatePostDateStruct': {'date': '2019-12-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-01-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of intraoperative hypotension', 'timeFrame': 'From beach chair positioning to the end of surgery (average of 1 hour up to 2 hours)', 'description': 'Mean blood pressure \\< 60 mmHg or systolic blood pressure \\< 80% of baseline'}], 'secondaryOutcomes': [{'measure': 'Incidence of intraoperative cerebral desaturation', 'timeFrame': 'From beach chair positioning to the end of surgery (average of 1 hour up to 2 hours)', 'description': 'Cerebral oxygen saturation \\< 80% of baseline longer than 30 seconds'}, {'measure': 'Total amounts of administered inotropic agents', 'timeFrame': 'From beach chair positioning to the end of surgery (average of 1 hour up to 2 hours)', 'description': 'Total amounts of administered inotropic agents after the Beach-chair positioning'}, {'measure': 'Systolic blood pressure', 'timeFrame': 'before induction(baseline) / before the Beach-chair positioning / 1,5,30 and 60 minutes after the Beach-chair positioning', 'description': 'Systolic blood pressure in mmHg at multiple time-points'}, {'measure': 'Heart rate', 'timeFrame': 'before induction(baseline) / before the Beach-chair positioning / 1,5,30 and 60 minutes after the Beach-chair positioning', 'description': 'Heart rate in bpm at multiple time-points'}, {'measure': 'Peripheral oxygen saturation', 'timeFrame': 'before induction(baseline) / before the Beach-chair positioning / 1,5,30 and 60 minutes after the Beach-chair positioning', 'description': 'Peripheral oxygen saturation in percentage at multiple time-points'}, {'measure': 'Cerebral oxygen saturation', 'timeFrame': 'before induction(baseline) / before the Beach-chair positioning / 1,5,30 and 60 minutes after the Beach-chair positioning', 'description': 'Cerebral oxygen saturation in percentage at multiple time-points'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Intraoperative Hypotension', 'Cerebral Ischemia', 'Shoulder Disease']}, 'referencesModule': {'references': [{'pmid': '41034767', 'type': 'DERIVED', 'citation': 'Nam S, Yoo S, Kim SH, Park SK, Lim YJ, Kim JT. Limited effect of leg elevation in preventing intraoperative hypotension during total shoulder arthroplasty in the beach chair position: a randomized controlled trial. BMC Anesthesiol. 2025 Oct 1;25(1):472. doi: 10.1186/s12871-025-03299-1.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to evaluate the effect of leg elevation on the prevention of intraoperative hypotension during shoulder surgery in the Beach-chair position. patients undergoing shoulder surgery in the Beach-chair position will be randomly assigned to Group L (with leg elevation) or Group C (no intervention). The primary outcome is the incidence of intraoperative hypotension (mean blood pressure \\< 60mmHg or systolic blood pressure \\< 80% of baseline). Secondary outcomes are the incidence of intraoperative cerebral desaturation (cerebral oxygen saturation \\< 80% of baseline, longer than 30 seconds), total amounts of administered inotropic agents, and systolic blood pressure, heart rate, and cerebral oxygen saturation at various time points.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adult patients undergoing shoulder surgery in the beach chair position\n\nExclusion Criteria:\n\n* Patients with myocardial infarction\n* Patients with pacemaker\n* Patients with cerebrovascular disease\n* patients with arteriovenous fistula at the opposite arm\n* Patients with autonomic nerve disorders\n* Patients with hip or knee joint disorder limiting hip or knee flexion\n* BMI \\> 30 kg/m2'}, 'identificationModule': {'nctId': 'NCT03393559', 'briefTitle': 'Effect of Leg Elevation on Prevention of Intraoperative Hypotension During Beach Chair Position', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'The Effect of Leg Elevation on the Prevention of Intraoperative Hypotension During Shoulder Surgery in the Beach Chair Position', 'orgStudyIdInfo': {'id': 'H-1712-023-903'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group L', 'description': 'leg elevation during the beach chair position', 'interventionNames': ['Procedure: leg elevation']}, {'type': 'NO_INTERVENTION', 'label': 'Group C', 'description': "Patients' leg will be straightened without any intervention."}], 'interventions': [{'name': 'leg elevation', 'type': 'PROCEDURE', 'description': "Patients' leg will be raised by a pillow under both legs and the hip and knee joints will be flexed 45 degrees to position both knees at the heart level.", 'armGroupLabels': ['Group L']}]}, 'contactsLocationsModule': {'locations': [{'zip': '110-744', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Jin-Tae Kim, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Seoul National University Hospital'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'timeFrame': 'IPD will be made available after article publication, for 3 years from the study completion.', 'ipdSharing': 'YES', 'accessCriteria': 'Proposals should be directed to the corresponding author and will be reviewed by the study group. Only requests that have a methodologically sound proposal and whose proposed use of the data has been approved by the independent review committee will be considered.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Jin-Tae Kim', 'investigatorAffiliation': 'Seoul National University Hospital'}}}}