{
  "FullStudy":{
    "Rank":217839,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01516164",
          "OrgStudyIdInfo":{
            "OrgStudyId":"2011AN04"
          },
          "Organization":{
            "OrgFullName":"NHS Tayside",
            "OrgClass":"OTHER_GOV"
          },
          "BriefTitle":"A Comparison of the Ease of Tracheal Intubation Using a McGrath MAC Laryngoscope and a Standard MacIntosh Laryngoscope",
          "OfficialTitle":"A Comparison of the Ease of Tracheal Intubation Using a McGrath MAC Laryngoscope and a Standard MacIntosh Laryngoscope"
        },
        "StatusModule":{
          "StatusVerifiedDate":"October 2014",
          "OverallStatus":"Completed",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"March 2012"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"February 2014",
            "PrimaryCompletionDateType":"Actual"
          },
          "CompletionDateStruct":{
            "CompletionDate":"February 2014",
            "CompletionDateType":"Actual"
          },
          "StudyFirstSubmitDate":"January 19, 2012",
          "StudyFirstSubmitQCDate":"January 23, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 24, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"October 3, 2014",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"October 6, 2014",
            "LastUpdatePostDateType":"Estimate"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Principal Investigator",
            "ResponsiblePartyInvestigatorFullName":"Dr Claire Wallace",
            "ResponsiblePartyInvestigatorTitle":"Dr Claire Wallace SpR Anaesthetics",
            "ResponsiblePartyInvestigatorAffiliation":"NHS Tayside"
          },
          "LeadSponsor":{
            "LeadSponsorName":"NHS Tayside",
            "LeadSponsorClass":"OTHER_GOV"
          }
        },
        "OversightModule":{
          "OversightHasDMC":"No"
        },
        "DescriptionModule":{
          "BriefSummary":"Videolaryngoscopes offer the potential to make tracheal intubation easier for the anaesthetist and less traumatic for the patient. This study aims to compare the intubation difficulty scores (a validated scoring system for ease of intubation) using the McGrath MAC as a videolaryngoscope, the McGrath MAC only as a direct laryngoscope (without video screen) and the MacIntosh laryngoscopes."
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Tracheal Intubation"
            ]
          },
          "KeywordList":{
            "Keyword":[
              "Laryngoscopy",
              "Videolaryngoscopy",
              "Ease of Intubation"
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Interventional",
          "PhaseList":{
            "Phase":[
              "Not Applicable"
            ]
          },
          "DesignInfo":{
            "DesignAllocation":"Randomized",
            "DesignInterventionModel":"Parallel Assignment",
            "DesignPrimaryPurpose":"Treatment",
            "DesignMaskingInfo":{
              "DesignMasking":"Single",
              "DesignWhoMaskedList":{
                "DesignWhoMasked":[
                  "Participant"
                ]
              }
            }
          },
          "EnrollmentInfo":{
            "EnrollmentCount":"158",
            "EnrollmentType":"Actual"
          }
        },
        "ArmsInterventionsModule":{
          "ArmGroupList":{
            "ArmGroup":[
              {
                "ArmGroupLabel":"MacIntosh",
                "ArmGroupType":"Active Comparator",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Device: Laryngoscopy"
                  ]
                }
              },{
                "ArmGroupLabel":"McGrath MAC direct",
                "ArmGroupType":"Active Comparator",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Device: Laryngoscopy"
                  ]
                }
              },{
                "ArmGroupLabel":"McGrath MAC indirect",
                "ArmGroupType":"Active Comparator",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Device: Laryngoscopy"
                  ]
                }
              }
            ]
          },
          "InterventionList":{
            "Intervention":[
              {
                "InterventionType":"Device",
                "InterventionName":"Laryngoscopy",
                "InterventionDescription":"After establishing full monitoring, inducing general anaesthesia and ensuring paralysis laryngoscopy is performed and the patient's trachea intubated.",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "MacIntosh",
                    "McGrath MAC direct",
                    "McGrath MAC indirect"
                  ]
                }
              }
            ]
          }
        },
        "OutcomesModule":{
          "PrimaryOutcomeList":{
            "PrimaryOutcome":[
              {
                "PrimaryOutcomeMeasure":"Intubation Difficulty Score",
                "PrimaryOutcomeDescription":"The Intubation Difficulty Scale (IDS) is a numerical score based on seven parameters. The scoring of each parameter represents a divergence from an 'ideal' condition and the total score represents a sum divergence from a zero difficulty ideal intubation. The seven parameters are number of supplementary attempts, number of supplementary operators, number and type of alternative techniques used, laryngoscopic grade, subjective lifting force, the use of external laryngeal manipulation and mobility or position of the vocal cords.",
                "PrimaryOutcomeTimeFrame":"5 minutes"
              }
            ]
          },
          "SecondaryOutcomeList":{
            "SecondaryOutcome":[
              {
                "SecondaryOutcomeMeasure":"Time to intubation",
                "SecondaryOutcomeTimeFrame":"5 minutes"
              },{
                "SecondaryOutcomeMeasure":"Number and types of alternative techniques used",
                "SecondaryOutcomeTimeFrame":"5 minutes"
              },{
                "SecondaryOutcomeMeasure":"Perception of force used",
                "SecondaryOutcomeTimeFrame":"5 minutes"
              },{
                "SecondaryOutcomeMeasure":"Complications",
                "SecondaryOutcomeTimeFrame":"5 minutes"
              },{
                "SecondaryOutcomeMeasure":"Ease of intubation",
                "SecondaryOutcomeTimeFrame":"5 minutes"
              },{
                "SecondaryOutcomeMeasure":"Failure to intubate",
                "SecondaryOutcomeTimeFrame":"5 minutes"
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion Criteria:\n\nElective procedure requiring oral tracheal tube intubation\nOver 16 years of age\nAirway assessment suggests to the anaesthetist that a standard MacIntosh laryngoscope approach to intubation would be appropriate.\n\nExclusion Criteria:\n\nEmergency procedure\nLess than 16 years of age\nUnable to consent\nRequiring Rapid Sequence Induction (a specialised anaesthetic induction technique)\nPredicted difficult intubation\nNot suitable for the standardised induction technique",
          "HealthyVolunteers":"No",
          "Gender":"All",
          "MinimumAge":"16 Years",
          "StdAgeList":{
            "StdAge":[
              "Child",
              "Adult",
              "Older Adult"
            ]
          }
        },
        "ContactsLocationsModule":{
          "OverallOfficialList":{
            "OverallOfficial":[
              {
                "OverallOfficialName":"Claire D Wallace, MBChB",
                "OverallOfficialAffiliation":"NHS Tayside",
                "OverallOfficialRole":"Principal Investigator"
              }
            ]
          },
          "LocationList":{
            "Location":[
              {
                "LocationFacility":"NHS Tayside",
                "LocationCity":"Tayside",
                "LocationCountry":"United Kingdom"
              }
            ]
          }
        }
      },
      "DerivedSection":{
        "MiscInfoModule":{
          "VersionHolder":"April 22, 2020"
        }
      }
    }
  }
}