Ignite Creation Date:
2025-12-25 @ 3:24 AM
Ignite Modification Date:
2026-01-09 @ 5:55 PM
Study NCT ID:
NCT06641505
Status:
RECRUITING
Last Update Posted:
2024-11-15
First Post:
2024-10-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Feasibility of Deep Inspiratory Internal Jugular Vein Variability in Guiding Preoperative Fluid Replacement
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': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'single'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2025-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-11-13', 'studyFirstSubmitDate': '2024-10-12', 'studyFirstSubmitQcDate': '2024-10-12', 'lastUpdatePostDateStruct': {'date': '2024-11-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The incidence of a 20% drop in blood pressure after propofol induction', 'timeFrame': '1 year', 'description': 'The incidence of a 20% drop in blood pressure after propofol induction'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Internal jugular vein', 'propofol', 'hemodynamic', 'hypotension', 'fluid replacement'], 'conditions': ['Hemodynamic']}, 'referencesModule': {'references': [{'pmid': '40676549', 'type': 'DERIVED', 'citation': 'Wei XL, Xi YZ, Xie L, Li ZP, Tang HL, Zhou QH. Effects of liquid resuscitation guided by internal jugular vein variability during deep inhalation on preventing propofol-induced hypotension in elderly patients. BMC Anesthesiol. 2025 Jul 17;25(1):350. doi: 10.1186/s12871-025-03227-3.'}]}, 'descriptionModule': {'briefSummary': 'Compare the incidence of hypotension during the propofol-induced period between the internal jugular vein variability-guided fluid infusion group and the conventional fluid infusion group through a fluid infusion experiment before anesthesia induction, so as to evaluate the feasibility of using the internal jugular vein variability under deep inspiration to guide preoperative fluid infusion.', 'detailedDescription': 'Ultrasound records at least one quiet breathing cycle and one deep inhalation cycle to calculate IJVV Propofol was infused target-controlled at 4 μg/ml, and changes in arterial blood pressure within 3 minutes of propofol induction were observed.\n\nPlan to conduct a prospective randomized controlled study to compare the incidence of hypotension during the propofol-induced period between the internal jugular vein variability-guided fluid infusion group and the conventional fluid infusion group through a fluid infusion experiment before anesthesia induction.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age over 60 years； American Society of Anesthesiology (ASA) status Ⅱ-Ⅲ； Surgery with radial artery puncture； Propofol induction；\n\nExclusion Criteria:\n\n* BMI≥30kg/m2； People with short necks； Previous hypotension (systolic blood pressure \\<90mmHg or mean arterial pressure\\<65mmHg)； Previous poorly controlled hypertension； Cardiac insufficiency , EF value\\<50%； Upper limb deep vein thrombosis； History of radiotherapy or neck surgery； Inability to maintain a supine position for necessary measurements； Mechanical ventilation status or inability to take deep breaths patients； gastrointestinal surgery； Patients allergic to propofol； Restricted fluid intake；'}, 'identificationModule': {'nctId': 'NCT06641505', 'briefTitle': 'Feasibility of Deep Inspiratory Internal Jugular Vein Variability in Guiding Preoperative Fluid Replacement', 'organization': {'class': 'OTHER', 'fullName': 'Affiliated Hospital of Jiaxing University'}, 'officialTitle': 'Feasibility of Deep Inspiratory Internal Jugular Vein Variability in Guiding Preoperative Fluid Replacement：A Prospective, Randomized Controlled Study', 'orgStudyIdInfo': {'id': '2024-KY-520'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Guiding rehydration group', 'description': 'According to the 421 fluid replacement principle, preoperative fluid replacement is performed', 'interventionNames': ['Behavioral: Guiding rehydration']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Conventional rehydration group', 'description': 'rehydrated within 15 minutes according to 0.2ml/kg/min.', 'interventionNames': ['Behavioral: Guiding rehydration']}], 'interventions': [{'name': 'Guiding rehydration', 'type': 'BEHAVIORAL', 'description': 'Preoperative fluid rehydration was performed according to 421 fluid rehydration principles', 'armGroupLabels': ['Conventional rehydration group', 'Guiding rehydration group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Jiaxing', 'state': 'Zhejiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Qinghe Zhou', 'role': 'CONTACT', 'email': 'jxxmxy@163.com', 'phone': '13732573379'}], 'facility': 'Affiliated Hospital of University', 'geoPoint': {'lat': 30.7522, 'lon': 120.75}}], 'centralContacts': [{'name': 'Qinghe Zhou', 'role': 'CONTACT', 'email': 'jxxmxy@163.com', 'phone': '13732573379'}, {'name': 'Xuelian Wei', 'role': 'CONTACT', 'email': '2275076157@qq.com', 'phone': '18133822661'}], 'overallOfficials': [{'name': 'Qinghe Zhou', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Affiliated Hospital of Jiaxing University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Affiliated Hospital of Jiaxing University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Qing-he Zhou', 'investigatorAffiliation': 'Affiliated Hospital of Jiaxing University'}}}}