Ignite Creation Date:
2025-12-24 @ 5:30 PM
Ignite Modification Date:
2025-12-29 @ 6:13 PM
Study NCT ID:
NCT05290168
Status:
UNKNOWN
Last Update Posted:
2022-05-05
First Post:
2022-01-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Normal Vascular Doppler Pattern of Abdominal Organ in Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-03-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2022-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-05-03', 'studyFirstSubmitDate': '2022-01-17', 'studyFirstSubmitQcDate': '2022-03-20', 'lastUpdatePostDateStruct': {'date': '2022-05-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'portal vein flow velocity (cm/s) during self respiration', 'timeFrame': 'just before anesthesia induction (about 5 minutes before anesthetic induction)'}, {'measure': 'portal vein flow velocity (cm/s) during general anesthesia', 'timeFrame': 'during positive pressure ventilation (within 5 - 60 minutes after anesthetic induction)'}, {'measure': 'splenic vein flow velocity (cm/s) during self respiration', 'timeFrame': 'just before anesthesia induction (about 5 minutes before anesthetic induction)'}, {'measure': 'inferior vena cava diameter (mm) during self respiration', 'timeFrame': 'just before anesthesia induction (about 5 minutes before anesthetic induction)'}, {'measure': 'inferior vena cava diameter (mm) during general anesthesia', 'timeFrame': 'during positive pressure ventilation (within 5 - 60 minutes after anesthetic induction)'}, {'measure': 'hepatic vein flow velocity (cm/s) during self respiration', 'timeFrame': 'just before anesthesia induction (about 5 minutes before anesthetic induction)'}, {'measure': 'hepatic vein flow velocity (cm/s) during general anesthesia', 'timeFrame': 'during positive pressure ventilation (within 5 - 60 minutes after anesthetic induction)'}, {'measure': 'renal artery/vein flow velocities (cm/s) during self respiration', 'timeFrame': 'just before anesthesia induction (about 5 minutes before anesthetic induction)'}, {'measure': 'renal artery/vein flow velocities (cm/s) during general anesthesia', 'timeFrame': 'during positive pressure ventilation (within 5 - 60 minutes after anesthetic induction)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Normal Children']}, 'descriptionModule': {'briefSummary': 'The following ultrasonic findings are obtained at both time points before and after induction of anesthesia (T1) and after induction (T2) in normal children . Positive pressure ventilation (Tidal volume of 6-8 ml/kg and a positive exhalation pressure of 5 cmH2O) is applied after anesthetic induction.\n\n1. Inferior vena cava diameter and distensibility\n2. Hepatic vein Doppler\n3. Portal vein Doppler\n4. Splenic artery and vein Doppler\n5. Renal artery and vein Doppler Based on this, the reference values for Doppler findings before and after anesthesia in normal children are obtained.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children undergoing simple surgery\n\nExclusion Criteria:\n\n* thoracic/abdominal surgery\n* surgery for congenital heart disease\n* disease involving liver, kidney, spleen\n* vascular disease'}, 'identificationModule': {'nctId': 'NCT05290168', 'briefTitle': 'Normal Vascular Doppler Pattern of Abdominal Organ in Children', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'Normal Vascular Doppler Pattern of Abdominal Organ in Children', 'orgStudyIdInfo': {'id': 'H2105-151-1222'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Normal children', 'description': 'normal children undergoing simple surgery', 'interventionNames': ['Diagnostic Test: abdominal Doppler']}], 'interventions': [{'name': 'abdominal Doppler', 'type': 'DIAGNOSTIC_TEST', 'description': '1. Inferior vena cava diameter and distensibility\n2. Hepatic vein Doppler\n3. Portal vein Doppler\n4. Splenic artery and vein Doppler\n5. Renal artery and vein Doppler', 'armGroupLabels': ['Normal children']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Jin-Tae Kim, MD. PhD', 'role': 'CONTACT', 'email': 'jintae73@gmail.com', 'phone': '82-2-2072-3664'}], 'facility': 'Jin-Tae Kim', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Jin-Tae Kim', 'role': 'CONTACT', 'email': 'jintae73@gmail.com', 'phone': '82-2-2072-3661', 'phoneExt': '82'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Jin-Tae Kim', 'investigatorAffiliation': 'Seoul National University Hospital'}}}}