{
  "FullStudy":{
    "Rank":217759,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01517204",
          "OrgStudyIdInfo":{
            "OrgStudyId":"KMUH-IRB-990305"
          },
          "Organization":{
            "OrgFullName":"Kaohsiung Medical University Chung-Ho Memorial Hospital",
            "OrgClass":"OTHER"
          },
          "BriefTitle":"The Efficacy of Trachway (R) Intubating Stylet in the Insertion of the Double Lumen Endobronchial Tube",
          "OfficialTitle":"The Comparison of Direct Laryngoscope and Trachway (R) Intubating Stylet in the Insertion of the Double Lumen Endobronchial Tube"
        },
        "StatusModule":{
          "StatusVerifiedDate":"May 2011",
          "OverallStatus":"Completed",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"May 2011"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"May 2012",
            "PrimaryCompletionDateType":"Actual"
          },
          "CompletionDateStruct":{
            "CompletionDate":"May 2012",
            "CompletionDateType":"Actual"
          },
          "StudyFirstSubmitDate":"November 15, 2011",
          "StudyFirstSubmitQCDate":"January 20, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 25, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"September 16, 2012",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"September 18, 2012",
            "LastUpdatePostDateType":"Estimate"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Sponsor"
          },
          "LeadSponsor":{
            "LeadSponsorName":"Kaohsiung Medical University Chung-Ho Memorial Hospital",
            "LeadSponsorClass":"OTHER"
          }
        },
        "OversightModule":{
          "OversightHasDMC":"Yes"
        },
        "DescriptionModule":{
          "BriefSummary":"The purpose of this study is to investigate the effects of Trachway(R) compared with direct laryngoscope in tracheal intubation of double-lumen endobronchial tube.",
          "DetailedDescription":"Intubation with the double-lumen endobronchial tube (DLT) remains a great challenge for anesthesiologists. Although new upper airway devices, such as Trachway (R), a video-assisted intubating stylet, had been developed for facilitating airway management.\n\nThe larger size and the complexity of DLT than single-lumen tube (SLT) makes the difficulties for DLT intubation. Therefore, the investigators designed this study to investigate the effects of Trachway(R)compared with direct laryngoscope in DLT intubation."
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Anesthesia Intubation Complications"
            ]
          },
          "KeywordList":{
            "Keyword":[
              "Trachway(R) intubating stylet",
              "Left sided double lumen endobronchial tube",
              "Efficacy",
              "Intubation complication"
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Interventional",
          "PhaseList":{
            "Phase":[
              "Not Applicable"
            ]
          },
          "DesignInfo":{
            "DesignAllocation":"Randomized",
            "DesignInterventionModel":"Parallel Assignment",
            "DesignPrimaryPurpose":"Treatment",
            "DesignMaskingInfo":{
              "DesignMasking":"Double",
              "DesignWhoMaskedList":{
                "DesignWhoMasked":[
                  "Investigator",
                  "Outcomes Assessor"
                ]
              }
            }
          },
          "EnrollmentInfo":{
            "EnrollmentCount":"60",
            "EnrollmentType":"Actual"
          }
        },
        "ArmsInterventionsModule":{
          "ArmGroupList":{
            "ArmGroup":[
              {
                "ArmGroupLabel":"Direct laryngoscope",
                "ArmGroupType":"Experimental",
                "ArmGroupDescription":"Direct laryngoscope was used to facilitate the intubation of left-sided double lumen endobronchial tube.",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Device: Direct laryngoscope (Macintoish laryngoscope)"
                  ]
                }
              },{
                "ArmGroupLabel":"Trachway(R) intubating stylet",
                "ArmGroupType":"Experimental",
                "ArmGroupDescription":"Trachway(R) intubating stylet was used to facilitate left-sided double lumen endobronchial tube intubation.",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Device: Trachway(R) intubating stylet"
                  ]
                }
              }
            ]
          },
          "InterventionList":{
            "Intervention":[
              {
                "InterventionType":"Device",
                "InterventionName":"Direct laryngoscope (Macintoish laryngoscope)",
                "InterventionDescription":"Direct laryngoscope was used to facilitate the intubation of left-sided DLT.",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "Direct laryngoscope"
                  ]
                },
                "InterventionOtherNameList":{
                  "InterventionOtherName":[
                    "Macintoish laryngoscope"
                  ]
                }
              },{
                "InterventionType":"Device",
                "InterventionName":"Trachway(R) intubating stylet",
                "InterventionDescription":"Trachway(R) intubating stylet was used to facilitate the intubation of left-sided DLT.",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "Trachway(R) intubating stylet"
                  ]
                },
                "InterventionOtherNameList":{
                  "InterventionOtherName":[
                    "The Clarus Video System"
                  ]
                }
              }
            ]
          }
        },
        "OutcomesModule":{
          "PrimaryOutcomeList":{
            "PrimaryOutcome":[
              {
                "PrimaryOutcomeMeasure":"Main outcome measure is the successful rate of the first intubation",
                "PrimaryOutcomeTimeFrame":"12 month"
              }
            ]
          },
          "SecondaryOutcomeList":{
            "SecondaryOutcome":[
              {
                "SecondaryOutcomeMeasure":"The outcome measure is the time needed to insert the DLT",
                "SecondaryOutcomeTimeFrame":"12 months"
              },{
                "SecondaryOutcomeMeasure":"The outcome measure is mean blood pressure (MAP) during intubation period",
                "SecondaryOutcomeDescription":"MAP was measured before intubation, and after intubation 1, 3,and 5 min.",
                "SecondaryOutcomeTimeFrame":"12 months"
              },{
                "SecondaryOutcomeMeasure":"The outcome measure is the heart rate (HR) during intubation period",
                "SecondaryOutcomeDescription":"HR was measured and recorded before intubation, and after intubation 1, 3,and 5 min.",
                "SecondaryOutcomeTimeFrame":"12 months"
              },{
                "SecondaryOutcomeMeasure":"The outcome measure is the incidence of hypoxemia.",
                "SecondaryOutcomeDescription":"Hypoxemia was defined as SPO2 less than 90%. Hypoxemia was recorded during the period of intubation.",
                "SecondaryOutcomeTimeFrame":"12 months"
              },{
                "SecondaryOutcomeMeasure":"The outcome measure is the incidence of sore throat.",
                "SecondaryOutcomeDescription":"Sore throat was observed and evaluated after extubation and patient regained consciousness.",
                "SecondaryOutcomeTimeFrame":"12 months"
              },{
                "SecondaryOutcomeMeasure":"The outcome measure is the incidence of hoarseness.",
                "SecondaryOutcomeDescription":"Hoarseness was observed and evaluated after extubation and patient regained consciousness.",
                "SecondaryOutcomeTimeFrame":"12 months"
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion Criteria:\n\npatients with American Society of Anesthesiologists physical status I-III\nMore than 18 years of age\nRequiring DLT for thoracic surgery\n\nExclusion Criteria:\n\nrisk of regurgitation and pulmonary aspiration\nhistory of gastroesophageal reflux, pregnancy\nscheduled tracheostomy and postoperative prolonged ventilation in ICU\npatients with limited neck extension (< 35°)\na distance between the tip of the patient's mandible and hyoid bone of less than 7 cm\na sternomental distance of less than 12.5 cm with the head fully extended\nmouth can not open",
          "HealthyVolunteers":"Accepts Healthy Volunteers",
          "Gender":"All",
          "MinimumAge":"18 Years",
          "StdAgeList":{
            "StdAge":[
              "Adult",
              "Older Adult"
            ]
          }
        },
        "ContactsLocationsModule":{
          "OverallOfficialList":{
            "OverallOfficial":[
              {
                "OverallOfficialName":"Hung-Te Hsu, VS",
                "OverallOfficialAffiliation":"Department of anesthesia, Kaoshiung medical university hospital",
                "OverallOfficialRole":"Principal Investigator"
              }
            ]
          },
          "LocationList":{
            "Location":[
              {
                "LocationFacility":"department of anesthesia, Kaohsiung medical university memorial hospital",
                "LocationCity":"Kaohsiung",
                "LocationZip":"807",
                "LocationCountry":"Taiwan"
              }
            ]
          }
        }
      },
      "DerivedSection":{
        "MiscInfoModule":{
          "VersionHolder":"April 22, 2020"
        },
        "InterventionBrowseModule":{
          "InterventionBrowseLeafList":{
            "InterventionBrowseLeaf":[
              {
                "InterventionBrowseLeafId":"M15385",
                "InterventionBrowseLeafName":"Tolnaftate",
                "InterventionBrowseLeafRelevance":"low"
              }
            ]
          },
          "InterventionBrowseBranchList":{
            "InterventionBrowseBranch":[
              {
                "InterventionBrowseBranchAbbrev":"Infe",
                "InterventionBrowseBranchName":"Anti-Infective Agents"
              },{
                "InterventionBrowseBranchAbbrev":"All",
                "InterventionBrowseBranchName":"All Drugs and Chemicals"
              }
            ]
          }
        }
      }
    }
  }
}