[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100619946":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":26,"centralContacts":31,"locations":36,"responsibleParty":56,"collaborators":25,"id":59,"slug":60,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":65,"eligibilityCriteria":66,"healthyVolunteers":67,"sex":68,"minAge":69,"maxAge":70,"enrollmentInfo":71,"targetDuration":25,"studyType":74,"phases":75,"briefSummary":77,"conditions":78,"keywords":83,"overallStatus":39,"whyStopped":25,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},{"fullName":5,"class":6},"University of Sao Paulo General Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"McGrath MAC","ACTIVE_COMPARATOR","Intubation the included participants with the McGrath MAC videolaryngoscope",[13],"Device: Intubation",{"label":15,"type":16,"description":17,"interventionNames":18},"BESDATA BD-DF","EXPERIMENTAL","Intubation the included participants with the BESDATA BD-DF videolaryngoscope",[13],[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DEVICE","Intubation","Intubation of pediatric patients under one year of age undergoing elective surgery under general anesthesia requiring orotracheal intubation, with one or another videolaryngoscope device.",[15,9],null,[27],{"name":28,"affiliation":29,"role":30},"Vinícius C Quintão, MD, PhD","Hospital das Clínicas HCFMUSP","PRINCIPAL_INVESTIGATOR",[32],{"name":28,"role":33,"phone":34,"phoneExt":25,"email":35},"CONTACT","5511971273950","vinicius.quintao@hc.fm.usp.br",[37],{"facility":38,"status":39,"city":40,"state":40,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"Instituto da Criança e do Adolescente, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo","RECRUITING","São Paulo","05403-000","Brazil","BR",{"type":45,"coordinates":46},"Point",[47,48],-46.63611,-23.5475,{"lat":48,"lon":47},[51,53],{"name":52,"role":33,"phone":34,"phoneExt":25,"email":35},"Vinicius C Quintão, MD, PhD",{"name":54,"role":55,"phone":25,"phoneExt":25,"email":25},"Lucas F Pereira","SUB_INVESTIGATOR",{"type":30,"investigatorFullName":57,"investigatorTitle":58,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"Vinícius C Quintão, MD, MSc, PhD","Assistant Professor","100619946","pediatric-airway-noninferiority-trial-of-devices-for-intubation-assessment-100619946",false,"NCT07351227","Pediatric Airway: Noninferiority Trial of Devices for Intubation Assessment","Comparison of the Effectiveness and Cost-Effectiveness of McGRATH™ MAC and Besdata Videolaryngoscopes in the Orotracheal Intubation of Children: A Non-Inferiority Randomized Clinical Trial","PANDA","Inclusion Criteria:\n\n* The study will include children aged between 6 months and 3 years who are scheduled for elective surgery under general anesthesia at the Children's Institute (Instituto da Criança - ICr) of the Hospital das Clínicas Complex, University of São Paulo Medical School (HC-FMUSP), provided that informed consent is obtained from their parents or legal guardians.\n\nExclusion Criteria:\n\n* Patients under one year of age will be excluded if informed consent is not obtained from their legal guardians, if they are classified as ASA physical status IV or higher, present with hemodynamic instability, or have craniofacial abnormalities or oral deformities suggestive of a potentially difficult airway.",true,"ALL","6 Months","3 Years",{"count":72,"type":73},226,"ESTIMATED","INTERVENTIONAL",[76],"NA","The goal of this clinical trial is to find out whether the BESDATA BD-DF videolaryngoscope works as well as the McGRATH™ MAC videolaryngoscope for placing a breathing tube in infants during surgery. The study will also compare the costs associated with using each device.\n\nThe main questions this study aims to answer are:\n\nIs the BESDATA BD-DF videolaryngoscope as effective as the McGRATH™ MAC videolaryngoscope for successful placement of a breathing tube on the first attempt in infants?\n\nAre there differences between the two devices in terms of procedure time, number of attempts, airway-related complications, and overall costs?\n\nResearchers will compare infants who are intubated using the BESDATA BD-DF videolaryngoscope with infants who are intubated using the McGRATH™ MAC videolaryngoscope to see whether the two devices perform similarly and whether one is more cost-effective than the other.\n\nParticipants will:\n\nBe randomly assigned to have a breathing tube placed using one of the two videolaryngoscopes;\n\nReceive standard general anesthesia for an elective surgical procedure;\n\nHave information collected during and after the procedure to assess safety, effectiveness, and costs.",[79,80,81,82],"Intubation, Intratracheal","Airway Management","Video Laryngoscope","Cost Effectiveness",[84,85,86,9,87],"Videolaryngoscope","Pediatric orotracheal intubation","Cost effectiveness","BESDATA","2026-03-18",{"date":90,"type":91},"2026-03-20","ACTUAL",{"date":93,"type":91},"2026-03-01",{"date":95,"type":73},"2027-12-31",{"name":5,"class":6},1]