{
  "FullStudy":{
    "Rank":217792,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01516775",
          "OrgStudyIdInfo":{
            "OrgStudyId":"KEK-ZH Nr. 2011-0034"
          },
          "Organization":{
            "OrgFullName":"University Children's Hospital, Zurich",
            "OrgClass":"OTHER"
          },
          "BriefTitle":"Gastric pH in Intubated Children",
          "OfficialTitle":"Untersuchung Des Magen-pH in Intubationsanästhesie Bei Kindern"
        },
        "StatusModule":{
          "StatusVerifiedDate":"September 2012",
          "OverallStatus":"Completed",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"January 2012"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"September 2012",
            "PrimaryCompletionDateType":"Actual"
          },
          "CompletionDateStruct":{
            "CompletionDate":"September 2012",
            "CompletionDateType":"Actual"
          },
          "StudyFirstSubmitDate":"January 16, 2012",
          "StudyFirstSubmitQCDate":"January 24, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 25, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"September 28, 2012",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"October 1, 2012",
            "LastUpdatePostDateType":"Estimate"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Sponsor-Investigator",
            "ResponsiblePartyInvestigatorFullName":"Achim Schmitz",
            "ResponsiblePartyInvestigatorTitle":"Principle Investigator, Consultant (\"Leitender Arzt Anästhesieabteilung, Leiter Weisse Zone\")",
            "ResponsiblePartyInvestigatorAffiliation":"University Children's Hospital, Zurich"
          },
          "LeadSponsor":{
            "LeadSponsorName":"Achim Schmitz",
            "LeadSponsorClass":"OTHER"
          }
        },
        "OversightModule":{
          "OversightHasDMC":"No"
        },
        "DescriptionModule":{
          "BriefSummary":"Fasting (according to ASA, ESA or institutional guidelines) is an important strategy to minimize the risk of regurgitation, vomiting and pulmonary aspiration during general anaesthesia; the effect of fasting time for clear fluid on gastric pH in children is goal of this study and can be investigated in children undergoing elective procedures in intubation anaesthesia without inconvenience or additional invasive procedure and hence without additional risk\n\nHypotheses: Gastric pH is higher in children that drink until 1 hour before anaesthesia induction than in those that drink until 2 hours before anaesthesia induction"
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Preoperative Fasting"
            ]
          },
          "KeywordList":{
            "Keyword":[
              "preoperative care",
              "preoperative period",
              "fasting"
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Interventional",
          "PhaseList":{
            "Phase":[
              "Not Applicable"
            ]
          },
          "DesignInfo":{
            "DesignAllocation":"Randomized",
            "DesignInterventionModel":"Parallel Assignment",
            "DesignPrimaryPurpose":"Basic Science",
            "DesignMaskingInfo":{
              "DesignMasking":"Single",
              "DesignWhoMaskedList":{
                "DesignWhoMasked":[
                  "Investigator"
                ]
              }
            }
          },
          "EnrollmentInfo":{
            "EnrollmentCount":"150",
            "EnrollmentType":"Actual"
          }
        },
        "ArmsInterventionsModule":{
          "ArmGroupList":{
            "ArmGroup":[
              {
                "ArmGroupLabel":"1 hour fluid fasting",
                "ArmGroupType":"Experimental",
                "ArmGroupDescription":"allowed to drink until 1 hour before scheduled anaesthesia induction",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Other: clear fluid ingestion"
                  ]
                }
              },{
                "ArmGroupLabel":"2 hours fluid fasting",
                "ArmGroupType":"Active Comparator",
                "ArmGroupDescription":"allowed to drink until 2 hour before scheduled anaesthesia induction",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Other: clear fluid ingestion"
                  ]
                }
              }
            ]
          },
          "InterventionList":{
            "Intervention":[
              {
                "InterventionType":"Other",
                "InterventionName":"clear fluid ingestion",
                "InterventionDescription":"drinking of clear fluid in preoperative period",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "1 hour fluid fasting",
                    "2 hours fluid fasting"
                  ]
                }
              }
            ]
          }
        },
        "OutcomesModule":{
          "PrimaryOutcomeList":{
            "PrimaryOutcome":[
              {
                "PrimaryOutcomeMeasure":"gastric pH",
                "PrimaryOutcomeDescription":"gastric pH is measured from gastric contents which is sampled in a syringe via an orogastric tube immediately during anaesthesia after tracheal intubation induction; suctioning of the stomach after intubation is a procedure routinely performed in every intubation child in our institution",
                "PrimaryOutcomeTimeFrame":"within 10 min after tracheal intubation"
              }
            ]
          },
          "SecondaryOutcomeList":{
            "SecondaryOutcome":[
              {
                "SecondaryOutcomeMeasure":"subjective feeling of hunger/thirst",
                "SecondaryOutcomeDescription":"subjective feeling of hunger/thirst given as rating scale from 1 to 4",
                "SecondaryOutcomeTimeFrame":"within 10 minutes after arrival of patient in operating theatre"
              },{
                "SecondaryOutcomeMeasure":"gastric aspirate volume",
                "SecondaryOutcomeDescription":"gastric aspirate volume is the amount of gastric contents which is sampled in a syringe via an orogastric tube immediately during anaesthesia after tracheal intubation induction; suctioning of the stomach after intubation is a procedure routinely performed in every intubation child in our institution",
                "SecondaryOutcomeTimeFrame":"within 10 min after tracheal intubation"
              },{
                "SecondaryOutcomeMeasure":"Postoperative Nausea and Vomiting (PONV) in recovery unit",
                "SecondaryOutcomeTimeFrame":"recovery period, on the average within 90 minutes after end of anaesthesia"
              },{
                "SecondaryOutcomeMeasure":"Behaviour during recovery period",
                "SecondaryOutcomeDescription":"Rating Scale 1 - 5 by blinded nurse (5: severely agitated/emergency delir with subsequent drug therapy, 4: agitated/emergeny delir; 3: slightly agitated; 2: complaining pain but cooperative; 1: cooperative)",
                "SecondaryOutcomeTimeFrame":"recovery period, on the average within 90 minutes after end of anaesthesia"
              },{
                "SecondaryOutcomeMeasure":"Behaviour during anaesthesia induction",
                "SecondaryOutcomeDescription":"Rating scale 1 - 5 by (blinded) anaesthetist: 1: cooperating - 2: anxious but cooperating - 3: hostile - 4: crying - 5: agitated/fighting",
                "SecondaryOutcomeTimeFrame":"on the average within 20 minutes after arrival of patient in operating theatre"
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion Criteria:\n\nage > 1 / <= 16 years\nASA class I or II\nelective surgery requiring general anaesthesia using tracheal intubation\n\nExclusion Criteria:\n\ndisease or dysfunction of gastrointestinal tract\nchronic diseases or conditions not compatible with ASA class I or II",
          "HealthyVolunteers":"No",
          "Gender":"All",
          "MinimumAge":"1 Year",
          "MaximumAge":"16 Years",
          "StdAgeList":{
            "StdAge":[
              "Child"
            ]
          }
        },
        "ContactsLocationsModule":{
          "OverallOfficialList":{
            "OverallOfficial":[
              {
                "OverallOfficialName":"Achim J Schmitz, MD",
                "OverallOfficialAffiliation":"University Children's Hospital, Zurich",
                "OverallOfficialRole":"Principal Investigator"
              }
            ]
          },
          "LocationList":{
            "Location":[
              {
                "LocationFacility":"University Children's Hospital",
                "LocationCity":"Zurich",
                "LocationZip":"4153",
                "LocationCountry":"Switzerland"
              }
            ]
          }
        },
        "ReferencesModule":{
          "ReferenceList":{
            "Reference":[
              {
                "ReferencePMID":"25501720",
                "ReferenceType":"derived",
                "ReferenceCitation":"Schmidt AR, Buehler P, Seglias L, Stark T, Brotschi B, Renner T, Sabandal C, Klaghofer R, Weiss M, Schmitz A. Gastric pH and residual volume after 1 and 2 h fasting time for clear fluids in children†. Br J Anaesth. 2015 Mar;114(3):477-82. doi: 10.1093/bja/aeu399. Epub 2014 Dec 13."
              }
            ]
          }
        }
      },
      "DerivedSection":{
        "MiscInfoModule":{
          "VersionHolder":"April 22, 2020"
        }
      }
    }
  }
}