Nctid:
NCT06232915
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-12-20"}}, "protocolSection"=>{"designModule"=>{"studyType"=>"OBSERVATIONAL", "designInfo"=>{"timePerspective"=>"PROSPECTIVE", "observationalModel"=>"COHORT"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>100}, "patientRegistry"=>false}, "statusModule"=>{"overallStatus"=>"NOT_YET_RECRUITING", "startDateStruct"=>{"date"=>"2024-10", "type"=>"ESTIMATED"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-08", "completionDateStruct"=>{"date"=>"2026-02", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-08-05", "studyFirstSubmitDate"=>"2024-01-22", "studyFirstSubmitQcDate"=>"2024-01-22", "lastUpdatePostDateStruct"=>{"date"=>"2024-08-06", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-31", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2026-02", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Mean inspired tidal volume", "timeFrame"=>"Baseline", "description"=>"The average volume of air moved into the lungs over 25 breaths."}, {"measure"=>"Mean expired tidal volume", "timeFrame"=>"Baseline", "description"=>"The average volume of air moved out of the lungs over 25 breaths."}]}, "oversightModule"=>{"oversightHasDmc"=>false, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"conditions"=>["Surgery", "Mechanical Ventilation Pressure High"]}, "descriptionModule"=>{"briefSummary"=>"Prior to surgery the anesthesia team will be putting a breathing tube into the patient's windpipe and attaching it to a mechanical ventilator (breathing machine). This is to provide oxygen and anesthetic gas, and to help the child breathe while they're asleep. The ventilator also controls the amount of air that moves in and out of the lungs with each breath. This is called tidal volume and that amount is programmed into the machine by the anesthesia team. All of this is standard of care.\n\nAs part of the study the investigators will put a small flow sensor between the patient's breathing tube and the tubing from the ventilator. This will measure the amount of air that is moving in and out of the breathing tube. The study team will record the tidal volume that is set on the ventilator and compare it to the airflow measured by the ventilator and the airflow measured by the sensor and see if there is a difference."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["CHILD", "ADULT"], "maximumAge"=>"18 years", "minimumAge"=>"0 years", "samplingMethod"=>"NON_PROBABILITY_SAMPLE", "studyPopulation"=>"Children requiring intraoperative mechanical ventilation.", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* children aged 0-18 years having surgery at Nationwide Children's Hospital, in whom a cuffed ETT and mechanical ventilation will be used\n\nExclusion Criteria:\n\n* children with preexisting airway anomalies or respiratory compromise will be excluded from the study."}, "identificationModule"=>{"nctId"=>"NCT06232915", "briefTitle"=>"Accuracy of the Set Tidal Volume During Intraoperative Mechanical Ventilation", "organization"=>{"class"=>"OTHER", "fullName"=>"Nationwide Children's Hospital"}, "officialTitle"=>"Accuracy of the Set Tidal Volume During Intraoperative Mechanical Ventilation", "orgStudyIdInfo"=>{"id"=>"STUDY00003946"}}, "armsInterventionsModule"=>{"armGroups"=>[{"label"=>"Mechanical ventilation", "description"=>"Children requiring mechanical ventilation during a surgical procedure.", "interventionNames"=>["Procedure: Mechanical ventilation"]}], "interventions"=>[{"name"=>"Mechanical ventilation", "type"=>"PROCEDURE", "description"=>"Mechanical ventilation during surgery", "armGroupLabels"=>["Mechanical ventilation"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"43205", "city"=>"Columbus", "state"=>"Ohio", "country"=>"United States", "facility"=>"Nationwide Children's Hospital", "geoPoint"=>{"lat"=>39.96118, "lon"=>-82.99879}}], "centralContacts"=>[{"name"=>"Julie Rice-Weimer, RN", "role"=>"CONTACT", "email"=>"julie.rice-weimer@nationwidechildrens.org", "phone"=>"6143553142"}, {"name"=>"Catherine Roth, MPH", "role"=>"CONTACT", "email"=>"catherine.roth@nationwidechildrens.org", "phone"=>"6147222997"}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"UNDECIDED"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Joseph D. Tobias", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"SPONSOR_INVESTIGATOR", "investigatorTitle"=>"Chief, Dept. of Anesthesiology & Pain Medicine", "investigatorFullName"=>"Joseph D. Tobias", "investigatorAffiliation"=>"Nationwide Children's Hospital"}}}}
