{
  "FullStudy":{
    "Rank":218252,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01510743",
          "OrgStudyIdInfo":{
            "OrgStudyId":"B1112_069_003"
          },
          "Organization":{
            "OrgFullName":"Seoul National University Bundang Hospital",
            "OrgClass":"OTHER"
          },
          "BriefTitle":"Ultrasound Guided Central Vein Catheterization and Complications",
          "OfficialTitle":"Incidence of Complication Depending on the Cannulation Site in US Guided Central Vein Catheterization"
        },
        "StatusModule":{
          "StatusVerifiedDate":"August 2018",
          "OverallStatus":"Completed",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"January 30, 2012",
            "StartDateType":"Actual"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"April 2018",
            "PrimaryCompletionDateType":"Actual"
          },
          "CompletionDateStruct":{
            "CompletionDate":"April 2018",
            "CompletionDateType":"Actual"
          },
          "StudyFirstSubmitDate":"January 9, 2012",
          "StudyFirstSubmitQCDate":"January 13, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 16, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"August 24, 2018",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"August 27, 2018",
            "LastUpdatePostDateType":"Actual"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Principal Investigator",
            "ResponsiblePartyInvestigatorFullName":"Hyo-Seok Na",
            "ResponsiblePartyInvestigatorTitle":"Assistant professor",
            "ResponsiblePartyInvestigatorAffiliation":"Seoul National University Bundang Hospital"
          },
          "LeadSponsor":{
            "LeadSponsorName":"Seoul National University Bundang Hospital",
            "LeadSponsorClass":"OTHER"
          }
        },
        "OversightModule":{
          "OversightHasDMC":"No"
        },
        "DescriptionModule":{
          "BriefSummary":"There has been no study comparing the complication rates between internal jugular vein catheterization and subclavian vein catheterization when they are performed using sonographic view. This prospective study would reveal the sort of complication and its rate."
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Brain Tumor"
            ]
          },
          "KeywordList":{
            "Keyword":[
              "open heart surgery",
              "lung surgery",
              "spine surgery",
              "hepatobiliary surgery"
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Interventional",
          "PhaseList":{
            "Phase":[
              "Not Applicable"
            ]
          },
          "DesignInfo":{
            "DesignAllocation":"Randomized",
            "DesignInterventionModel":"Parallel Assignment",
            "DesignPrimaryPurpose":"Supportive Care",
            "DesignMaskingInfo":{
              "DesignMasking":"None (Open Label)"
            }
          },
          "EnrollmentInfo":{
            "EnrollmentCount":"1484",
            "EnrollmentType":"Actual"
          }
        },
        "ArmsInterventionsModule":{
          "ArmGroupList":{
            "ArmGroup":[
              {
                "ArmGroupLabel":"Group SC",
                "ArmGroupType":"Active Comparator",
                "ArmGroupDescription":"US guided subclavian vein catheterization",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Procedure: Catheterization of subclavian vein"
                  ]
                }
              },{
                "ArmGroupLabel":"Group IJ",
                "ArmGroupType":"Active Comparator",
                "ArmGroupDescription":"US-guided internal jugular vein catheterization",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Procedure: Catheterization of internal jugular vein"
                  ]
                }
              }
            ]
          },
          "InterventionList":{
            "Intervention":[
              {
                "InterventionType":"Procedure",
                "InterventionName":"Catheterization of subclavian vein",
                "InterventionDescription":"Catheterization of subclavian vein",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "Group SC"
                  ]
                }
              },{
                "InterventionType":"Procedure",
                "InterventionName":"Catheterization of internal jugular vein",
                "InterventionDescription":"Catheterization of internal jugular vein",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "Group IJ"
                  ]
                }
              }
            ]
          }
        },
        "OutcomesModule":{
          "PrimaryOutcomeList":{
            "PrimaryOutcome":[
              {
                "PrimaryOutcomeMeasure":"complication",
                "PrimaryOutcomeDescription":"any one of arterial puncture, hematoma, pneumothorax, hemothorax",
                "PrimaryOutcomeTimeFrame":"during central vein catheterization and operation day"
              }
            ]
          },
          "SecondaryOutcomeList":{
            "SecondaryOutcome":[
              {
                "SecondaryOutcomeMeasure":"Access time",
                "SecondaryOutcomeDescription":"from penetration of skin to aspiration of venous blood into the syringe",
                "SecondaryOutcomeTimeFrame":"during central venous catheterization"
              },{
                "SecondaryOutcomeMeasure":"Number of attempts",
                "SecondaryOutcomeDescription":"once/twice/three times",
                "SecondaryOutcomeTimeFrame":"during central venous catheterization"
              },{
                "SecondaryOutcomeMeasure":"catheter tip placement",
                "SecondaryOutcomeDescription":"After reviewing the postoperative chest X ray film, we will check the position of the central venous catheter tip. The possible pisition of catheter tip is as follows:\n\n(1) Superior vena cava and Rirht Atrium junction (2)Right internal jugular vein (3)Left Internal jugular vein (4)Right Axillary vein (5)Lt. Axillary vein",
                "SecondaryOutcomeTimeFrame":"postoperative 1 day"
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion Criteria:\n\nPatients undergoing surgeries requiring central vein catheterizations for anesthetic management.\n\nExclusion Criteria:\n\nRefuse\nhematologic disorder\nAnatomical abnormalities of central vein structure",
          "HealthyVolunteers":"No",
          "Gender":"All",
          "MinimumAge":"15 Years",
          "StdAgeList":{
            "StdAge":[
              "Child",
              "Adult",
              "Older Adult"
            ]
          }
        },
        "ContactsLocationsModule":{
          "OverallOfficialList":{
            "OverallOfficial":[
              {
                "OverallOfficialName":"Jin-Hee Kim, Professor",
                "OverallOfficialAffiliation":"Seoul National University Bundang Hospital",
                "OverallOfficialRole":"Study Director"
              }
            ]
          },
          "LocationList":{
            "Location":[
              {
                "LocationFacility":"Seoul National University Bundang Hospital",
                "LocationCity":"Seongnam",
                "LocationState":"Gyounggi",
                "LocationZip":"463-707",
                "LocationCountry":"Korea, Republic of"
              }
            ]
          }
        }
      },
      "DerivedSection":{
        "MiscInfoModule":{
          "VersionHolder":"April 22, 2020"
        },
        "ConditionBrowseModule":{
          "ConditionMeshList":{
            "ConditionMesh":[
              {
                "ConditionMeshId":"D000001932",
                "ConditionMeshTerm":"Brain Neoplasms"
              }
            ]
          },
          "ConditionAncestorList":{
            "ConditionAncestor":[
              {
                "ConditionAncestorId":"D000016543",
                "ConditionAncestorTerm":"Central Nervous System Neoplasms"
              },{
                "ConditionAncestorId":"D000009423",
                "ConditionAncestorTerm":"Nervous System Neoplasms"
              },{
                "ConditionAncestorId":"D000009371",
                "ConditionAncestorTerm":"Neoplasms by Site"
              },{
                "ConditionAncestorId":"D000009369",
                "ConditionAncestorTerm":"Neoplasms"
              },{
                "ConditionAncestorId":"D000001927",
                "ConditionAncestorTerm":"Brain Diseases"
              },{
                "ConditionAncestorId":"D000002493",
                "ConditionAncestorTerm":"Central Nervous System Diseases"
              },{
                "ConditionAncestorId":"D000009422",
                "ConditionAncestorTerm":"Nervous System Diseases"
              }
            ]
          },
          "ConditionBrowseLeafList":{
            "ConditionBrowseLeaf":[
              {
                "ConditionBrowseLeafId":"M3791",
                "ConditionBrowseLeafName":"Brain Neoplasms",
                "ConditionBrowseLeafAsFound":"Brain Tumor",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M17520",
                "ConditionBrowseLeafName":"Central Nervous System Neoplasms",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M10950",
                "ConditionBrowseLeafName":"Nervous System Neoplasms",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M3786",
                "ConditionBrowseLeafName":"Brain Diseases",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M4325",
                "ConditionBrowseLeafName":"Central Nervous System Diseases",
                "ConditionBrowseLeafRelevance":"low"
              }
            ]
          },
          "ConditionBrowseBranchList":{
            "ConditionBrowseBranch":[
              {
                "ConditionBrowseBranchAbbrev":"BC04",
                "ConditionBrowseBranchName":"Cancers and Other Neoplasms"
              },{
                "ConditionBrowseBranchAbbrev":"BC10",
                "ConditionBrowseBranchName":"Nervous System Diseases"
              },{
                "ConditionBrowseBranchAbbrev":"All",
                "ConditionBrowseBranchName":"All Conditions"
              }
            ]
          }
        }
      }
    }
  }
}