[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100560549":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":24,"centralContacts":24,"locations":24,"responsibleParty":25,"collaborators":24,"id":27,"slug":28,"hasResults":29,"nctId":30,"briefTitle":31,"officialTitle":32,"acronym":24,"eligibilityCriteria":33,"healthyVolunteers":34,"sex":35,"minAge":36,"maxAge":24,"enrollmentInfo":37,"targetDuration":24,"studyType":40,"phases":41,"briefSummary":43,"conditions":44,"keywords":24,"overallStatus":47,"whyStopped":24,"lastUpdateSubmitDate":48,"lastUpdatePostDateStruct":49,"startDateStruct":52,"completionDateStruct":54,"leadSponsor":56,"locationsCount":24},{"fullName":5,"class":6},"Luzerner Kantonsspital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Igel","SHAM_COMPARATOR","Control device",[13],"Device: Igelplus",{"label":15,"type":16,"description":17,"interventionNames":18},"Igelplus","ACTIVE_COMPARATOR","Study device",[13],[20],{"type":21,"name":15,"description":22,"armGroupLabels":23,"otherNames":24},"DEVICE","Intubation with Igelplus laryngeal mask",[9,15],null,{"type":26,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR","100560549","comparison-of-gastric-insufflation-with-the-classic-igel-laryngeal-mask-and-the-new-igelplus-laryngeal-mask-using-gastric-ultrasound-100560549",false,"NCT06578598","Comparison of Gastric Insufflation With the Classic Igel Laryngeal Mask and the New Igelplus Laryngeal Mask Using Gastric Ultrasound","Comparison of Gastric Air Insufflation and Ventilation Between Two Laryngeals Masks (LMA): Igel and Igelplus","Inclusion Criteria:\n\n* Patients with ASA classification 1-2\n* Undergoing elective surgery\n* Body Mass Index (BMI) \\\u003C 35\n* No contraindications for the laryngeal mask\n\nExclusion Criteria:\n\n* Presence of contraindications for the laryngeal mask\n* Urgent or non-elective surgeries",true,"ALL","18 Years",{"count":38,"type":39},200,"ESTIMATED","INTERVENTIONAL",[42],"NA","This study aims to compare the effectiveness and safety of two types of laryngeal masks- iGel and iGel Plus, used during elective surgeries. The focus is on evaluating differences in gastric insufflation and ventilation parameters between these two devices. Participants will be patients classified as ASA 1-2 with a BMI of less than 35, undergoing elective procedures.\n\nThe study is designed as a prospective, randomized, controlled trial with 200 subjects divided evenly between the two laryngeal mask groups. Key outcomes include gastric cross-sectional area (CSA) measurements before and after surgery, ventilation metrics such as leakage pressure and PEEP, and the incidence of postoperative complications like nausea and respiratory issues.",[45,46],"Surgery","Anesthesia","NOT_YET_RECRUITING","2024-08-27",{"date":50,"type":51},"2024-08-29","ACTUAL",{"date":53,"type":39},"2024-10-01",{"date":55,"type":39},"2025-12-01",{"name":5,"class":6}]