[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100650350":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":31,"centralContacts":40,"locations":46,"responsibleParty":61,"collaborators":64,"id":67,"slug":68,"hasResults":69,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":73,"eligibilityCriteria":74,"healthyVolunteers":75,"sex":76,"minAge":77,"maxAge":31,"enrollmentInfo":78,"targetDuration":31,"studyType":81,"phases":82,"briefSummary":84,"conditions":85,"keywords":89,"overallStatus":97,"whyStopped":31,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":107},{"fullName":5,"class":6},"Kocaeli City Hospital","OTHER_GOV",[8,14,20],{"label":9,"type":10,"description":11,"interventionNames":12},"EPATS","EXPERIMENTAL","Participants will perform endotracheal intubation using the EPATS (Integrated Tube-Bougie Prototype) in both normal and difficult airway simulation scenarios.",[13],"Device: EPATS (Integrated Tube-Bougie Prototype)",{"label":15,"type":16,"description":17,"interventionNames":18},"Standard Gum Elastic Bougie","ACTIVE_COMPARATOR","Participants will perform endotracheal intubation using a standard gum elastic bougie in both normal and difficult airway simulation scenarios.",[19],"Device: Standard gum elastic bougie",{"label":21,"type":16,"description":22,"interventionNames":23},"Standard Stylet","Participants will perform endotracheal intubation using a standard stylet in both normal and difficult airway simulation scenarios.",[24],"Device: Standard stylet",[26,32,36],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"DEVICE","EPATS (Integrated Tube-Bougie Prototype)","The novel integrated tube-bougie prototype developed for endotracheal intubation.",[9],null,{"type":27,"name":33,"description":34,"armGroupLabels":35,"otherNames":31},"Standard gum elastic bougie","Standard gum elastic bougie used as an intubation adjunct.",[15],{"type":27,"name":37,"description":38,"armGroupLabels":39,"otherNames":31},"Standard stylet","Standard intubating stylet used as an intubation adjunct.",[21],[41],{"name":42,"role":43,"phone":44,"phoneExt":31,"email":45},"Huseyin Cahit Halhalli, MD","CONTACT","+902622252700","huseyin.halhalli@sbu.edu.tr",[47],{"facility":48,"status":31,"city":49,"state":50,"zip":51,"country":52,"countryCode":31,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"University of Health Sciences, Kocaeli City Hospital","Köseköy","Kocaeli","41060","Turkey (Türkiye)",{"type":54,"coordinates":55},"Point",[56,57],30.00556,40.74012,{"lat":57,"lon":56},[60],{"name":42,"role":43,"phone":44,"phoneExt":31,"email":45},{"type":62,"investigatorFullName":42,"investigatorTitle":63,"investigatorAffiliation":5,"oldNameTitle":31,"oldOrganization":31},"SPONSOR_INVESTIGATOR","Associate Professor and Emergency Medicine Residency Program Director",[65],{"name":66,"class":6},"Health Institutes of Turkey","100650350","novel-integrated-tube-bougie-prototype-for-endotracheal-intubation-in-airway-simulation-100650350",false,"NCT07747922","Novel Integrated Tube-Bougie Prototype for Endotracheal Intubation in Airway Simulation","A Prospective Randomized Crossover Simulation Study Comparing an Integrated Tube-Bougie Prototype With Standard Stilet-Assisted and Gum Elastic Bougie Assisted Endotracheal Intubation","ITBP","Inclusion Criteria:\n\n* Professional Status: Being an Emergency Medicine Resident actively undergoing specialty training at the University of Health Sciences, Kocaeli City Hospital, Department of Emergency Medicine.\n* Voluntary Participation: Voluntarily agreeing to participate in the study and providing written informed consent prior to enrollment.\n* Postgraduate year (PGY) 1-4 residents.\n* Willing and able to provide written informed consent.\n\nExclusion Criteria:\n\n* Refusal to Participate: Declining to participate or refusing to provide written informed consent.\n* Physical or Neurological Limitations: Having any pre-existing physical, motor, or neurological impairment that could interfere with manual dexterity, procedural performance, or airway management simulation (e.g., hand injuries, tremors, etc.).\n* Inability to complete all study procedures.",true,"ALL","18 Years",{"count":79,"type":80},40,"ESTIMATED","INTERVENTIONAL",[83],"NA","Endotracheal intubation is a critical airway management procedure that frequently requires adjunctive devices, such as stylets or elastic bougies, to facilitate successful tube placement. Although videolaryngoscopy has become increasingly common, access to videolaryngoscopes remains limited in certain clinical settings, particularly in prehospital and resource-constrained environments. Consequently, stylets and bougies continue to play an essential role in airway management. To address this need, we developed a novel integrated tube-bougie prototype that combines the guidance function of an elastic bougie with an endotracheal tube into a single device.\n\nThis prospective, randomized, crossover simulation study is designed to compare the performance of the integrated tube-bougie prototype with conventional stylet-assisted and elastic bougie-assisted endotracheal intubation. Emergency medicine residents will perform intubations using all three techniques in both normal and difficult airway simulation scenarios according to a randomized crossover sequence.\n\nThe primary outcome is the time to successful endotracheal intubation. Secondary outcomes include first-attempt intubation success, perceived procedural difficulty assessed using a visual analog scale (VAS), incidence of esophageal intubation, dental trauma, and evaluation of the learning curve using cumulative sum (CUSUM) analysis.\n\nThe findings could contribute to the development of alternative airway assistive equipment for emergency airway management and training.",[86,87,88],"Airway Management","Endotracheal Intubation","Difficult Airway",[88,87,86,90,91,92,93,94,95,9,96],"Emergency Medicine","Simulation","Manikin","Bougie","Gum Elastic Bougie","Stylet","Medical Education","NOT_YET_RECRUITING","2026-07-31",{"date":100,"type":101},"2026-08-05","ACTUAL",{"date":103,"type":80},"2026-08-10",{"date":105,"type":80},"2026-08-30",{"name":42,"class":6},1]