[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100608643":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":35,"locations":42,"responsibleParty":57,"collaborators":26,"id":61,"slug":62,"hasResults":63,"nctId":64,"briefTitle":65,"officialTitle":66,"acronym":67,"eligibilityCriteria":68,"healthyVolunteers":69,"sex":70,"minAge":71,"maxAge":72,"enrollmentInfo":73,"targetDuration":26,"studyType":76,"phases":77,"briefSummary":79,"conditions":80,"keywords":83,"overallStatus":44,"whyStopped":26,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},{"fullName":5,"class":6},"Kocaeli City Hospital","OTHER_GOV",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Guedel Group","ACTIVE_COMPARATOR","Guedel airway will be the first device during mask ventilation",[13],"Device: Guedel Airway",{"label":15,"type":16,"description":17,"interventionNames":18},"Tulip Group","EXPERIMENTAL","Tulip airway wil be the initial device for mask ventilation",[19],"Device: Tulip Airway",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","Tulip Airway","In this study, patients scheduled for surgery under general anesthesia who meet the criteria for anticipated difficult mask ventilation will be included. Randomization will be performed to determine which device will be used first. If the Tulip airway is selected as the first device in the randomization process, mask ventilation will be initiated with the Tulip airway.",[15],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Guedel Airway","In this study, patients scheduled for surgery under general anesthesia who meet the criteria for anticipated difficult mask ventilation will be included. Randomization will be performed to determine which device will be used first. If the Guedel airway is selected as the first device in the randomization process, mask ventilation will be initiated with the Guedel airway.",[9],[32],{"name":33,"affiliation":5,"role":34},"Ayşe Z Turan Cıvraz, Assoc. Prof.","PRINCIPAL_INVESTIGATOR",[36,40],{"name":33,"role":37,"phone":38,"phoneExt":26,"email":39},"CONTACT","+905054695850","ayse.zeynep@gmail.com",{"name":41,"role":37,"phone":26,"phoneExt":26,"email":39},"Bedirhan Günel, MD",[43],{"facility":5,"status":44,"city":45,"state":46,"zip":47,"country":48,"countryCode":26,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"RECRUITING","İzmit","Kocaeli","41060","Turkey (Türkiye)",{"type":50,"coordinates":51},"Point",[52,53],29.92928,40.76499,{"lat":53,"lon":52},[56],{"name":33,"role":37,"phone":38,"phoneExt":26,"email":39},{"type":58,"investigatorFullName":59,"investigatorTitle":60,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"SPONSOR_INVESTIGATOR","Ayse Zeynep Turan Civraz","Assoc.Prof.","100608643","tulip-airway-in-difficult-mask-ventilation-tadmv-100608643",false,"NCT07204223","Tulip Airway in Difficult Mask Ventilation (TADMV)","Comparison of the Tulip Airway and the Guedel Airway in Anticipated Difficult Mask Ventilation: A Prospective, Randomized, Controlled Crossover Trial","TADMV","Inclusion Criteria:\n\n* Patients aged between 18 and 75 years\n* Patients scheduled for elective surgery under general anesthesia\n* Patients with at least two risk factors for difficult mask ventilation, including:\n* Age over 55 years\n* Presence of beard\n* Edentulism (missing teeth)\n* Obesity (Body Mass Index (BMI) ≥ 30 kg\u002Fm²)\n* History of obstructive sleep apnea syndrome (OSAS) or snoring\n* Neck circumference \\> 43 cm\n* Retrognathia (small jaw structure)\n* Patients classified as American Society of Anesthesiologist (ASA) physical status 1, 2, or 3\n* Patients who provide informed consent\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding women\n* Patients with a history of airway surgery (e.g., tracheostomy, maxillofacial surgery)\n* Patients with severe cardiopulmonary diseases (e.g., advanced Chronic obstructive Pulmonary Disease (COPD), pulmonary hypertension, severe heart failure)\n* Patients with craniofacial anomalies or significant anatomical airway deformities\n* Patients requiring emergency surgery\n* Patients with gastroesophageal reflux disease (GERD) and high risk of aspiration\n* Patients with active upper respiratory tract infection\n* Patients with a history of difficult intubation",true,"ALL","18 Years","75 Years",{"count":74,"type":75},30,"ESTIMATED","INTERVENTIONAL",[78],"NA","During surgery, right after anesthesia is given, the first step to help the patient breathe is to provide breathing support with a mask. This step is very important because if there is a problem with mask ventilation, the anesthesia team must quickly use other methods to help the patient breathe.\n\nFor some people, mask ventilation can be more difficult. Factors such as older age, having a beard, missing teeth, being overweight, sleep apnea, or certain facial shapes can make this process harder.\n\nTo make mask ventilation easier, special devices placed in the mouth are used. The most common one is called the Guedel airway. In recent years, a new device called the Tulip airway has also been introduced. The shape and features of the Tulip airway are designed to make breathing support easier.\n\nIn this study, we will compare the Tulip airway and the Guedel airway in patients who are expected to have more difficult mask ventilation. Our goal is to find out which device makes it easier and safer to help patients breathe.",[81,82],"Difficult Mask Ventilation","Airway Devices",[84,85,86,87],"guedel airway","airway management","difficult bag mask ventilation","tulip airway","2025-11-16",{"date":90,"type":91},"2025-11-18","ACTUAL",{"date":93,"type":91},"2025-10-01",{"date":95,"type":75},"2025-12-31",{"name":59,"class":6},1]