Ignite Creation Date:
2025-12-25 @ 1:25 AM
Ignite Modification Date:
2025-12-26 @ 6:07 AM
Study NCT ID:
NCT01680393
Status:
UNKNOWN
Last Update Posted:
2012-09-07
First Post:
2012-02-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sequential Compression Device (SCD) for Stabilizing Hemodynamics in the Beach Chair Position
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007022', 'term': 'Hypotension'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2011-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-09', 'completionDateStruct': {'date': '2012-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-09-04', 'studyFirstSubmitDate': '2012-02-01', 'studyFirstSubmitQcDate': '2012-09-04', 'lastUpdatePostDateStruct': {'date': '2012-09-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-09-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'cerebral oxygenation', 'timeFrame': 'per minute', 'description': 'cerebral oxygenation averaged of 1 min during the operation'}], 'secondaryOutcomes': [{'measure': 'ephedrine', 'timeFrame': 'throughout duration of anaesthesia, approximately 60 minutes', 'description': 'amount of ephedrine used during surgery'}, {'measure': 'cardiac output', 'timeFrame': 'per minute', 'description': 'cardiac output averaged over 1 minute during the entire surgery'}, {'measure': 'Stroke volume', 'timeFrame': 'per minute', 'description': 'stroke volume averaged over 1 minute during the entire surgery'}, {'measure': 'mean arterial pressure', 'timeFrame': 'per minute', 'description': 'MAP averaged over 1 minute during the entire surgery'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Hypotension']}, 'descriptionModule': {'briefSummary': 'This study is a 3-legged randomized study examining whether during shoulder surgery performed in the beach chair position active compressions of the lower leg with a sequential compression device (SCD) have a superior effect on stabilizing cerebral and circulatory hemodynamics when compared to TED stockings or a control group without any stockings.', 'detailedDescription': 'This study examines whether during shoulder surgery performed in the beach chair position active compressions of the lower leg with a sequential compression device (SCD) have a superior effect on stabilizing cerebral and circulatory hemodynamics when compared to TED stockings or a control group without any stockings.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adult patients undergoing elective shoulder surgery\n\nExclusion Criteria:\n\n* untreated hypertension\n* no pulse in a. dorsalis pedis or a.tibialis posterior\n* leg ulcers\n* failed scalenous blockade'}, 'identificationModule': {'nctId': 'NCT01680393', 'briefTitle': 'Sequential Compression Device (SCD) for Stabilizing Hemodynamics in the Beach Chair Position', 'organization': {'class': 'OTHER', 'fullName': 'Bispebjerg Hospital'}, 'officialTitle': 'Stabilizing Cerebral and Circulatory Hemodynamics During Shoulder Surgery in the Beach Chair Position Using Sequential Compression Device (SCD) or TED Stockings Compared to a Control Group', 'orgStudyIdInfo': {'id': 'BBH290511BRAINshoulderscd'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sequential compression device', 'description': 'During arthroscopic shoulder surgery, an SCD device will be applied to the patients legs during surgery. Cerebral oxygenation and circulatory parameters will be recorded continuously throughout the surgery. Recordings will be hidden to the primary caregiver.', 'interventionNames': ['Device: Sequential compression device']}, {'type': 'EXPERIMENTAL', 'label': 'TED stockings', 'description': 'During arthroscopic shoulder surgery, TED stockings will be applied to the patients legs during surgery. Cerebral oxygenation and circulatory parameters will be recorded continuously throughout the surgery. Recordings will be hidden to the primary caregiver.', 'interventionNames': ['Other: TED stockings']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'no stockings will be applied to the patients legs'}], 'interventions': [{'name': 'Sequential compression device', 'type': 'DEVICE', 'otherNames': ['SCD express Kendall'], 'description': 'a sequential compression device will be applied to the legs', 'armGroupLabels': ['Sequential compression device']}, {'name': 'TED stockings', 'type': 'OTHER', 'otherNames': ['TED compression stockings, Kendall'], 'description': 'TED stockings will be applied to the patients legs during surgery', 'armGroupLabels': ['TED stockings']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2200', 'city': 'Copenhagen', 'state': 'Copenhagen N', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Frank Pott, MD, DMsc', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Bispebjerg Hospital', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}], 'centralContacts': [{'name': 'Frank Pott, MD, DMsc', 'role': 'CONTACT', 'email': 'frank.pott@gmail.com'}], 'overallOfficials': [{'name': 'Frank Pott, MD,DMsc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Anesthesiology, Bispebjerg Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bispebjerg Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, DMSc', 'investigatorFullName': 'Frank Christian Pott, MD', 'investigatorAffiliation': 'Bispebjerg Hospital'}}}}