[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100629850":3},{"organization":4,"armGroups":7,"interventions":26,"overallOfficials":32,"centralContacts":42,"locations":54,"responsibleParty":72,"collaborators":32,"id":76,"slug":77,"hasResults":78,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":32,"eligibilityCriteria":82,"healthyVolunteers":78,"sex":83,"minAge":84,"maxAge":85,"enrollmentInfo":86,"targetDuration":32,"studyType":89,"phases":90,"briefSummary":92,"conditions":93,"keywords":32,"overallStatus":95,"whyStopped":32,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":105},{"fullName":5,"class":6},"Benha University","OTHER",[8,14,18,22],{"label":9,"type":10,"description":11,"interventionNames":12},"group A","EXPERIMENTAL","This arm will be subjected to inspiratory pressure 10 cmH₂O",[13],"Device: \"Ultrasound-Guided Optimization of Inspiratory Pressure During Facemask Ventilation\"",{"label":15,"type":10,"description":16,"interventionNames":17},"group B","This arm will be subjected to inspiratory pressure 15 cmH₂O",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"group C","This arm will be subjected to inspiratory pressure 20 cmH₂O",[13],{"label":23,"type":10,"description":24,"interventionNames":25},"group D","This arm will be subjected to inspiratory pressure 25 cmH₂O",[13],[27,33,36,39],{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"DEVICE","\"Ultrasound-Guided Optimization of Inspiratory Pressure During Facemask Ventilation\"","Description: Group A will be subjected to an inspiratory pressure of 10 cmH₂O. A curvilinear ultrasound probe will be placed in the epigastric region to visualize the antrum. Baseline gastric ultrasound will be performed to confirm an empty stomach. During FMV, ultrasound images will be obtained at 30, 60, and 90 seconds. Gastric insufflation will be detected by the change in gastric cross-sectional area (ΔCSA).",[9],null,{"type":28,"name":29,"description":34,"armGroupLabels":35,"otherNames":32},"Description: Group B will be subjected to an inspiratory pressure of 15 cmH₂O. A curvilinear ultrasound probe will be placed in the epigastric region to visualize the antrum. Baseline gastric ultrasound will be performed to confirm an empty stomach. During FMV, ultrasound images will be obtained at 30, 60, and 90 seconds. Gastric insufflation will be detected by the change in gastric cross-sectional area (ΔCSA).",[15],{"type":28,"name":29,"description":37,"armGroupLabels":38,"otherNames":32},"Description: Group C will be subjected to an inspiratory pressure of 20 cmH₂O. A curvilinear ultrasound probe will be placed in the epigastric region to visualize the antrum. Baseline gastric ultrasound will be performed to confirm an empty stomach. During FMV, ultrasound images will be obtained at 30, 60, and 90 seconds. Gastric insufflation will be detected by the change in gastric cross-sectional area (ΔCSA).",[19],{"type":28,"name":29,"description":40,"armGroupLabels":41,"otherNames":32},"Description: Group D will be subjected to an inspiratory pressure of 25 cmH₂O. A curvilinear ultrasound probe will be placed in the epigastric region to visualize the antrum. Baseline gastric ultrasound will be performed to confirm an empty stomach. During FMV, ultrasound images will be obtained at 30, 60, and 90 seconds. Gastric insufflation will be detected by the change in gastric cross-sectional area (ΔCSA).",[23],[43,49],{"name":44,"role":45,"phone":46,"phoneExt":47,"email":48},"mohamed a mustafa, MSC","CONTACT","+201022708985","+201144616418","mhmdabdelrazik248@gmail.com",{"name":50,"role":45,"phone":51,"phoneExt":52,"email":53},"alaa b mohamed, MBBCH","+201019680699","+201098073650","alabam7m@gmail.com",[55],{"facility":56,"status":32,"city":57,"state":32,"zip":32,"country":58,"countryCode":59,"cosmosGeoPoint":60,"geoPoint":65,"contacts":66},"Benha University Hospitals","Banhā","Egypt","EG",{"type":61,"coordinates":62},"Point",[63,64],31.1842,30.45977,{"lat":64,"lon":63},[67],{"name":68,"role":45,"phone":69,"phoneExt":70,"email":71},"nasser k el-gizawy, MD","0020133231011","0020133231012","info@bu.edu.eg",{"type":73,"investigatorFullName":74,"investigatorTitle":75,"investigatorAffiliation":5,"oldNameTitle":32,"oldOrganization":32},"PRINCIPAL_INVESTIGATOR","Mohamed abd-elrazik mustafa mansour mohamed","assistant lecturer","100629850","determination-of-the-optimal-inspiratory-pressure-to-decrease-incidence-of-gastric-insufflation-with-adequate-ventilation-during-facemask-ventilation-in-morbidly-obese-patients-100629850",false,"NCT07480031","Determination of the Optimal Inspiratory Pressure to Decrease Incidence of Gastric Insufflation With Adequate Ventilation During Facemask Ventilation in Morbidly Obese Patients","Ultrasound-Guided Optimization of Inspiratory Pressure During Facemask Ventilation in Morbidly Obese Patients to Prevent Gastric Insufflation: A Randomized Clinical Trial","Inclusion Criteria:\n\n* Adult patients (18-65 years old) scheduled for elective surgery under general anesthesia requiring facemask ventilation.\n\n  * Morbid obesity (BMI ≥40 kg\u002Fm²).\n  * American Society of Anesthesiologists (ASA) physical status II-III.\n  * Normal upper gastrointestinal anatomy (no history of gastric surgery, esophageal strictures, or hiatus hernia).\n  * Fasted for at least 6 hours for solids and 2 hours for fluids (standard preoperative fasting guidelines).\n\nExclusion Criteria:\n\n* • Emergency surgery (due to inability to ensure proper fasting or preoperative assessment).\n\n  * Known or suspected difficult airway (Mallampati class IV, limited neck mobility, or history of difficult intubation).\n  * Gastroesophageal reflux disease (GERD) or high aspiration risk (e.g., pregnancy, symptomatic hiatal hernia).\n  * Contraindications to facemask ventilation (facial trauma, beard\u002Fmask seal interference).\n  * Severe cardiopulmonary disease (e.g., severe COPD, pulmonary hypertension, or unstable angina).\n  * Neuromuscular disorders affecting respiratory function.\n  * Refusal to participate or inability to provide informed consent.","ALL","18 Years","65 Years",{"count":87,"type":88},144,"ESTIMATED","INTERVENTIONAL",[91],"NA","The goal of this randomized clinical trial is to optimize the inspiratory pressure during facemask ventilation (FMV) in morbidly obese patients (BMI ≥40 kg\u002Fm²), to ensure adequate ventilation while minimizing the risk of gastric insufflation by real-time ultrasound guidance",[94],"Gastric Insufflation","NOT_YET_RECRUITING","2026-03-14",{"date":98,"type":99},"2026-03-18","ACTUAL",{"date":101,"type":88},"2026-04-01",{"date":103,"type":88},"2027-04-15",{"name":5,"class":6},1]