Ignite Creation Date:
2025-12-24 @ 10:59 PM
Ignite Modification Date:
2025-12-25 @ 8:29 PM
Study NCT ID:
NCT06112769
Status:
COMPLETED
Last Update Posted:
2025-03-12
First Post:
2023-10-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Correlation Study of Internal Jugular Vein Variability Under Deep Inhalation and Propofol-induced Hypotension
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 64}, 'targetDuration': '1 Day', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-10-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2024-01-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-10', 'studyFirstSubmitDate': '2023-10-29', 'studyFirstSubmitQcDate': '2023-10-29', 'lastUpdatePostDateStruct': {'date': '2025-03-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-11-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'IJVV during deep inhalation', 'timeFrame': '1 year', 'description': 'IJVV (%) = (diamax - diamin)/\\[(diamax + diamin)/2\\] × 100'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Internal jugular vein', 'propofol', 'hypotension', 'hemodynamic'], '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': 'The correlation between internal jugular vein variability during deep inhalation and the decrease in blood pressure during propofol induction.', 'detailedDescription': '1. Ultrasound records at least one quiet breathing cycle and one deep inhalation cycle to calculate IJVV\n2. Propofol was infused target-controlled at 4 μg/ml, and changes in arterial blood pressure within 3 minutes of propofol induction were observed.\n3. Aim to conduct a prospective observational study to evaluate the correlation between internal jugular vein variability during deep inhalation and the decrease in blood pressure during propofol induction.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients undergoing intravenous general anesthesia surgery at Jiaxing First Hospital', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age over 60 years\n* American Society of Anesthesiology (ASA) status Ⅱ-Ⅲ\n* Surgery with radial artery puncture\n* Propofol induction\n\nExclusion Criteria:\n\n* BMI≥30kg/m2\n* People with short necks;\n* Previous hypotension (systolic blood pressure \\<90mmHg or mean arterial pressure \\<65mmHg)\n* Previous poorly controlled hypertension\n* Cardiac insufficiency , EF value\\<50%\n* Upper limb deep vein thrombosis\n* History of radiotherapy or neck surgery\n* Inability to maintain a supine position for necessary measurements\n* Mechanical ventilation status or inability to take deep breaths patients\n* gastrointestinal surgery\n* patients allergic to propofol.'}, 'identificationModule': {'nctId': 'NCT06112769', 'briefTitle': 'A Correlation Study of Internal Jugular Vein Variability Under Deep Inhalation and Propofol-induced Hypotension', 'organization': {'class': 'OTHER', 'fullName': 'Affiliated Hospital of Jiaxing University'}, 'officialTitle': 'A Correlation Study of Internal Jugular Vein Variability Under Deep Inhalation and Propofol-induced Hypotension', 'orgStudyIdInfo': {'id': '2023-KY-603'}}, 'contactsLocationsModule': {'locations': [{'zip': '314000', 'city': 'Jiaxing', 'state': 'Zhejiang', 'country': 'China', 'facility': 'Affiliated Hospital of Jiaxing University', 'geoPoint': {'lat': 30.7522, 'lon': 120.75}}], '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'}}}}