{
  "FullStudy":{
    "Rank":217798,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01516697",
          "OrgStudyIdInfo":{
            "OrgStudyId":"2011-P-001449"
          },
          "Organization":{
            "OrgFullName":"Massachusetts General Hospital",
            "OrgClass":"OTHER"
          },
          "BriefTitle":"Non-invasive Cardiac Output Monitoring in Obstetric Patients",
          "OfficialTitle":"Using Thoracic Electrical Bioimpedance to Measure Stroke Volume and Cardiac Output in Patients Under Spinal Anesthesia for Cesarean Section"
        },
        "StatusModule":{
          "StatusVerifiedDate":"January 2017",
          "OverallStatus":"Withdrawn",
          "WhyStopped":"unable to enrollment subjects due to early departure of study personele",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"October 2011"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"September 2012",
            "PrimaryCompletionDateType":"Anticipated"
          },
          "CompletionDateStruct":{
            "CompletionDate":"September 2012",
            "CompletionDateType":"Anticipated"
          },
          "StudyFirstSubmitDate":"January 12, 2012",
          "StudyFirstSubmitQCDate":"January 19, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 25, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"January 15, 2017",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"January 18, 2017",
            "LastUpdatePostDateType":"Estimate"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Principal Investigator",
            "ResponsiblePartyInvestigatorFullName":"Yandong Jiang",
            "ResponsiblePartyInvestigatorTitle":"Assistant professor",
            "ResponsiblePartyInvestigatorAffiliation":"Massachusetts General Hospital"
          },
          "LeadSponsor":{
            "LeadSponsorName":"Massachusetts General Hospital",
            "LeadSponsorClass":"OTHER"
          }
        },
        "OversightModule":{
          "OversightHasDMC":"No"
        },
        "DescriptionModule":{
          "BriefSummary":"The investigators hypothesize that continuously measuring stroke volume (SV) and cardiac output (CO) will 1) reveal hemodynamic instability in a timely manner and alert the physician promptly, 2) provide information for the physician to make the differential diagnosis as to whether the hemodynamic instability was due to vasodilatation or reduction of venous blood return, and 3) lead to appropriate and prompt treatment to improve patient outcome.\n\n-determine the SV and CO and their kinetic change using ICON® to establish a hemodynamic profile of the patient under spinal anesthesia for cesarean section. To determine if using instantaneous measurements of SV and CO to guide patient management improves hemodynamic stability."
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Complications; Cesarean Section",
              "Anesthesia; Adverse Effect, Spinal and Epidural"
            ]
          },
          "KeywordList":{
            "Keyword":[
              "thoracic electric bioimpedance",
              "cardiac output monitoring",
              "cesarean section",
              "spinal anesthesia"
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Interventional",
          "PhaseList":{
            "Phase":[
              "Phase 4"
            ]
          },
          "DesignInfo":{
            "DesignAllocation":"Randomized",
            "DesignInterventionModel":"Parallel Assignment",
            "DesignPrimaryPurpose":"Diagnostic",
            "DesignMaskingInfo":{
              "DesignMasking":"Single",
              "DesignWhoMaskedList":{
                "DesignWhoMasked":[
                  "Outcomes Assessor"
                ]
              }
            }
          },
          "EnrollmentInfo":{
            "EnrollmentCount":"0",
            "EnrollmentType":"Actual"
          }
        },
        "ArmsInterventionsModule":{
          "ArmGroupList":{
            "ArmGroup":[
              {
                "ArmGroupLabel":"Control",
                "ArmGroupType":"Other",
                "ArmGroupDescription":"The patients in Group A will serve as controls and will receive standard monitoring in addition to continuous measurement of SV and CO. The physicians will not know the CO and SV and will manage the patients in a standard fashion.",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Procedure: Control"
                  ]
                }
              },{
                "ArmGroupLabel":"experimental",
                "ArmGroupType":"Experimental",
                "ArmGroupDescription":"The patients in Group B will receive the same monitoring as those in Group A. But the physicians will know instantaneously the CO and SV in real time and will manage the patients accordingly.",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Procedure: experimental"
                  ]
                }
              }
            ]
          },
          "InterventionList":{
            "Intervention":[
              {
                "InterventionType":"Procedure",
                "InterventionName":"experimental",
                "InterventionDescription":"Non-invasive cardiac output monitoring using thoracic electric bioimpedance analysis via ICON® in addition of the standard monitoring during cesarean section.",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "experimental"
                  ]
                }
              },{
                "InterventionType":"Procedure",
                "InterventionName":"Control",
                "InterventionDescription":"Data obtained from the non-invasive cardiac output monitor,ICON®, are not available for the anesthesia care providers.",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "Control"
                  ]
                }
              }
            ]
          }
        },
        "OutcomesModule":{
          "PrimaryOutcomeList":{
            "PrimaryOutcome":[
              {
                "PrimaryOutcomeMeasure":"Maximum percentage changes in mean blood pressure after spinal anesthesia",
                "PrimaryOutcomeTimeFrame":"baseline before spinal anesthesia and up to 20 minutes after spinal anesthesia"
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion Criteria:\n\nage 18-45;\nreceiving spinal anesthesia or combined spinal and epidural anesthesia to undergo cesarean section\n\nExclusion Criteria:\n\nPatients who have major cardiovascular disease,preexisting of hypertension or gestational hypertension, preeclampsia and body mass index greater than 35kg/m2;\nPatients who have skin lesion at the place where the electrode is supposed to be applied;\nEmergency cesarean section patients.",
          "HealthyVolunteers":"No",
          "Gender":"Female",
          "MinimumAge":"18 Years",
          "MaximumAge":"45 Years",
          "StdAgeList":{
            "StdAge":[
              "Adult"
            ]
          }
        },
        "ContactsLocationsModule":{
          "OverallOfficialList":{
            "OverallOfficial":[
              {
                "OverallOfficialName":"Yandong Jiang, MD, PhD",
                "OverallOfficialAffiliation":"Massachusetts General Hospital",
                "OverallOfficialRole":"Principal Investigator"
              }
            ]
          },
          "LocationList":{
            "Location":[
              {
                "LocationFacility":"Massachusetts General Hospital",
                "LocationCity":"Boston",
                "LocationState":"Massachusetts",
                "LocationZip":"02114",
                "LocationCountry":"United States"
              }
            ]
          }
        }
      },
      "DerivedSection":{
        "MiscInfoModule":{
          "VersionHolder":"April 22, 2020"
        },
        "ConditionBrowseModule":{
          "ConditionBrowseLeafList":{
            "ConditionBrowseLeaf":[
              {
                "ConditionBrowseLeafId":"M20890",
                "ConditionBrowseLeafName":"Stroke",
                "ConditionBrowseLeafRelevance":"low"
              }
            ]
          },
          "ConditionBrowseBranchList":{
            "ConditionBrowseBranch":[
              {
                "ConditionBrowseBranchAbbrev":"BC10",
                "ConditionBrowseBranchName":"Nervous System Diseases"
              },{
                "ConditionBrowseBranchAbbrev":"BC14",
                "ConditionBrowseBranchName":"Heart and Blood Diseases"
              },{
                "ConditionBrowseBranchAbbrev":"All",
                "ConditionBrowseBranchName":"All Conditions"
              }
            ]
          }
        }
      }
    }
  }
}