Ignite Creation Date:
2025-12-25 @ 12:40 AM
Ignite Modification Date:
2025-12-25 @ 10:51 PM
Study NCT ID:
NCT03553667
Status:
UNKNOWN
Last Update Posted:
2018-06-12
First Post:
2018-05-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Using the "Edwards" EV1000 Clinical Platform NI in Lymphatic Venous Anastomosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2018-06-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-12', 'completionDateStruct': {'date': '2018-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-05-30', 'studyFirstSubmitDate': '2018-05-07', 'studyFirstSubmitQcDate': '2018-05-30', 'lastUpdatePostDateStruct': {'date': '2018-06-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-06-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Fluid responsiveness', 'timeFrame': 'after induction until recovery from anesthesia, assessed up to 24 hours', 'description': 'After fluid challenge, MAP changes in Standard group or SV changes in ClearSight group'}, {'measure': 'Postoperative adverse events', 'timeFrame': 'postoperative 30 days', 'description': 'Including ileus, infection, and cardiovascular events'}, {'measure': 'Postoperative nausea and vomiting', 'timeFrame': 'postoperative 24 hours', 'description': 'Postoperative nausea and vomiting'}, {'measure': 'Recovery time', 'timeFrame': 'From the stop of propofol infusion until full orientation of patient, up to 2 hours', 'description': 'From the stop of propofol infusion until full orientation of patient. Full orientation needs patients to be aware of where they are and who they are.'}], 'primaryOutcomes': [{'measure': 'Maximal MAP fluctuation', 'timeFrame': 'after induction until recovery from anesthesia, assessed up to 24 hours', 'description': 'In standard group, MAP(mean arterial pressure measured from arterial line), maximum minus minimum'}, {'measure': 'Maximal change of SVV', 'timeFrame': 'after induction until recovery from anesthesia, assessed up to 24 hours', 'description': 'In ClearSight group, SVV(stroke volume variation measured from ClearSight), maximum minus minimum'}], 'secondaryOutcomes': [{'measure': 'Urine output', 'timeFrame': 'after induction until recovery from anesthesia, assessed up to 24 hours', 'description': 'urine output ml/kg/h'}, {'measure': 'Creatinine', 'timeFrame': 'preanesthesia and 24 hours postanesthesia', 'description': 'Creatinine (serum)'}, {'measure': 'Acute kidney injury', 'timeFrame': 'Loss of kidney function that develops within 7 days after surgery', 'description': 'use AKIN/RIFLE criteria'}, {'measure': 'Total fluid volume (ml)', 'timeFrame': 'after induction until recovery from anesthesia, assessed up to 24 hours', 'description': 'In both groups, total crystalloid fluid volume used during anesthesia'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hemodynamic Monitoring', 'Perioperative Care', 'Outcome Assessment'], 'conditions': ['Hemodynamic Monitoring', 'Perioperative Care', 'Outcome Assessment']}, 'descriptionModule': {'briefSummary': 'Lymphatic venous anastomosis could be applied on patients suffering from limb lymphedema after surgery or radiotherapy. The particular pathophysiology leads unconventional fluid treatment strategy and changes in urine output. Hemodynamic monitors shows the benefits in perianesthetic care in fluid maintenance and decrease postanesthetic complication.\n\nInvasive hemodynamic monitors, such as arterial line and FlowTrac, have risks of hematoma, infection, nerve injury in puncture site. In this study, photoplethysmography is applied comparing with conventional mean arterial pressure for perianesthetic hemodynamic optimization in bispectral index (BIS)-guided target-controlled infusion sedation on lymphatic venous anastomosis.', 'detailedDescription': 'After allocation, patients would be assigned to Standard group or ClearSight group. All patients will be sedative with BIS-guided Propofol/Alfentanil Target-Controlled Infusion. The BIS will be maintained between 40-70 with electromyography(EMG) \\< 30%. Ce(effect site concentration) of Propofol is adjusted according to BIS score. Ce of Alfentanil is adjusted between 15-75 ng/ml. Patients have spontaneous respiration during the procedure with O2 simple mask. If the oxygen saturation by pulse oximetry(SpO2) \\< 95%, prescribe chin lift first. Nasopharyngeal airways is given if chin lift can not improve the saturation. Crystalloid, usually Lactate Ringer, is infused with the rate 4ml/kg/hr. The goal of Standard group is to maintain mean arterial pressure(MAP) \\> 60%. If MAP \\< 60%, 3ml/kg crystalloid is challenged in 10 minutes. If MAP still less than 60% after the second fluid challenge, Ephedrine 4-8mg iv is prescribed. ClearSight group is to maintain stroke volume(SV). If SV decreases more than 10%, 3ml/kg crystalloid is challenged in 10 minutes. If MAP still less than 60% after the second fluid challenge, Ephedrine 4-8mg iv is prescribed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject receiving lymphatic venous anastomosis operation with Bispectral-guided Propofol and Alfentanil target-controlled anesthesia\n* Subject agrees to participate the study\n\nExclusion Criteria:\n\n* Age less than 18 years old\n* Creatinine clearance \\< 30ml/min\n* Vulnerable populations, including children, pregnant women, inmates, and persons with no capacity or with limited capacity'}, 'identificationModule': {'nctId': 'NCT03553667', 'briefTitle': 'Using the "Edwards" EV1000 Clinical Platform NI in Lymphatic Venous Anastomosis', 'organization': {'class': 'OTHER', 'fullName': 'Chang Gung Memorial Hospital'}, 'officialTitle': 'Perioperative Hemodynamic Optimization Using the "Edwards" EV1000 Clinical Platform NI in Lymphatic Venous Anastomosis', 'orgStudyIdInfo': {'id': '201701797B0'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Standard group', 'description': 'Adult patients, Creatinine clearance \\>= 30ml/min, with limb lymphedema, receiving lymphatic venous anastomosis', 'interventionNames': ['Device: Standard group']}, {'type': 'EXPERIMENTAL', 'label': 'ClearSight', 'description': 'Adult patients, Creatinine clearance \\>= 30ml/min, with limb lymphedema, receiving lymphatic venous anastomosis', 'interventionNames': ['Device: ClearSight']}], 'interventions': [{'name': 'Standard group', 'type': 'DEVICE', 'otherNames': ['S group'], 'description': 'Use radial arterial line to monitor mean arterial pressure', 'armGroupLabels': ['Standard group']}, {'name': 'ClearSight', 'type': 'DEVICE', 'otherNames': ['CS group'], 'description': 'Use Edwards EV1000 Clinical Platform NI with ClearSight finger sleeve to monitor SV(stroke volume)', 'armGroupLabels': ['ClearSight']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Min-Hsien Chiang, M.D.', 'role': 'CONTACT', 'email': 'b9005035@cgmh.org.tw', 'phone': '+886-7-7317123', 'phoneExt': '2788'}, {'name': 'Johnson Chia-Shen Yang, M.D.', 'role': 'CONTACT', 'phone': '+886-7-7317123', 'phoneExt': '2788'}], 'overallOfficials': [{'name': 'Shao-Chun Wu, M.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'Department of Anesthesiology, Kaohsiung Chang Gung Memorial Hospital and Chang Gung University College of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chang Gung Memorial Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}