Ignite Creation Date:
2025-12-24 @ 6:31 PM
Ignite Modification Date:
2025-12-29 @ 9:41 AM
Study NCT ID:
NCT06215157
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-01-22
First Post:
2024-01-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Comparison of Stroke Volume Variation for Prediction of Fluid Responsiveness
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-01-30', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2025-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-01-10', 'studyFirstSubmitDate': '2024-01-10', 'studyFirstSubmitQcDate': '2024-01-10', 'lastUpdatePostDateStruct': {'date': '2024-01-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-01-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The capacity to predict fluid responsiveness.', 'timeFrame': 'From anesthesia induction to the nonresponsive VLS about one hour.', 'description': 'After anesthesia induction, volume loading was initiated. For each volume loading step (VLS), 100 mL of colloid solution (6% hydroxyethyl starch) was administered over a 2-minute duration. The SVV was measured and recorded simultaneously by FloTrac (SVV-FloTrac) and Transthoracic electrical bioimpedance(SVV-BioZ). Volume loading steps (VLS) continued until no responsive VLS was observed. Responsive VLS, defined as an increase in Flotrac-SV by at least 5%, and nonresponsive VLS, characterized by no change or an increase in Flotrac-SV by less than 5%, were subsequently identified. Multiple analysis methods were used to determine the capacity to predict the fluid responsiveness of these two devices.'}], 'secondaryOutcomes': [{'measure': 'The agreement between simultaneously measured SVV-FloTrac and SVV-BioZ', 'timeFrame': 'From anesthesia induction to the nonresponsive VLS about one hour.', 'description': 'After anesthesia induction, volume loading was initiated. For each volume loading step (VLS), 100 mL of colloid solution (6% hydroxyethyl starch) was administered over a 2-minute duration. The SVV was measured and recorded simultaneously by FloTrac (SVV-FloTrac) and Transthoracic electrical bioimpedance(SVV-BioZ). Volume loading steps (VLS) continued until no responsive VLS was observed. Responsive VLS, defined as an increase in Flotrac-SV by at least 5%, and nonresponsive VLS, characterized by no change or an increase in Flotrac-SV by less than 5%, were subsequently identified. Multiple analysis methods were used to determine the agreement of the two SVVs.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Stroke Volume Variation', 'SVV-FloTrac', 'Thoracic Electrical Bioimpedance', 'Fluid Responsiveness']}, 'descriptionModule': {'briefSummary': "Stroke volume variation (SVV) is an indicator used to assess the patient's volume status. The FloTrac system (Edwards Lifesciences, Irvine, CA) continuously monitors cardiac output (CO) and SVV (SVV-FloTrac) by analyzing the systemic arterial pressure wave. Numerous studies have demonstrated that SVV-FloTrac serves as a reliable indicator of fluid responsiveness. However, its peripheral invasiveness raises concerns about susceptibility to reflecting waves, damping, and vascular tone influences.In contrast, Transthoracic electrical bioimpedance (BioZ.com™) offers a non-invasive approach for continuously monitoring various hemodynamic variables. In this study, the primary aim was to assess the agreement between simultaneously measured SVV-FloTrac and SVV-BioZ."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18≤ Age ≤65\n* patients undergoinglaparoscopic elective surgery for gastrointestinal tumors under general anesthesia\n* 18 kg/m2≤BMI≤30 kg/m2\n* ASA classification I-III\n* Patients signed informed consent form\n\nExclusion Criteria:\n\n* Arrhythmias\n* The patient is diagnosed with severe cardiovascular disease（pulmonary arterial hypertension、left ventricular ejection fraction\\< 50%、aortic aneurysm、extensive peripheral arterial occlusive disease,、significant valvulopathy）\n* Severe heart failure (METS\\<4)\n* The patient is diagnosed with severe hepatic dysfunction (ChildePugh class C)\n* The patient is diagnosed with severe renal dysfunction (undergoing dialysis before surgery)\n* There is an infectious lesion on the skin or subcutaneous tissue where the non-invasive electrode piece is placed\n* History of allergy to anesthetic drugs\n* Weight\\<40kg\n* Allergies to 6% hydroxyethyl starch, Fresenius Kabi, Deutschland'}, 'identificationModule': {'nctId': 'NCT06215157', 'briefTitle': 'A Comparison of Stroke Volume Variation for Prediction of Fluid Responsiveness', 'organization': {'class': 'OTHER', 'fullName': 'RenJi Hospital'}, 'officialTitle': 'A Comparison of Stroke Volume Variation for Prediction of Fluid Responsiveness Measured by Thoracic Electrical Bioimpedance and FloTrac/Vigileo', 'orgStudyIdInfo': {'id': 'TEB-Zhoujie'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Flotrac Group', 'description': 'In this group,an arterial catheter was inserted preoperatively. An indwelling radial artery catheter was connected to the hemodynamic monitoring system (EV1000; Edward Lifesciences Corp., Irvine, CA, USA) via FloTrac™ (Edwards Lifesciences Corp.) sensors.', 'interventionNames': ['Device: Flotrac Group']}, {'type': 'EXPERIMENTAL', 'label': 'BioZ Group', 'description': 'In this group,haemodynamic parameters were collected simultaneously by the thoracic bioimpedance (BioZ.com™) monitoring.', 'interventionNames': ['Device: BioZ Group']}], 'interventions': [{'name': 'Flotrac Group', 'type': 'DEVICE', 'description': 'Haemodynamic parameters were collected simultaneously by the Flotrac monitoring.', 'armGroupLabels': ['Flotrac Group']}, {'name': 'BioZ Group', 'type': 'DEVICE', 'description': 'Haemodynamic parameters were collected simultaneously by the thoracic bioimpedance (BioZ.com™)monitoring.', 'armGroupLabels': ['BioZ Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200127', 'city': 'Pudong', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Renji Hospital, Shanghai Jiaotong University School of Medicine', 'geoPoint': {'lat': 31.23995, 'lon': 121.50094}}], 'centralContacts': [{'name': 'Diansan Su, Dr.', 'role': 'CONTACT', 'email': 'diansansu@yahoo.com', 'phone': '+862168383702'}, {'name': 'Yuwen Chen', 'role': 'CONTACT', 'email': '15373748@qq.com', 'phone': '+862168383702'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'RenJi Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}