[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100617179":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":26,"locations":26,"responsibleParty":31,"collaborators":26,"id":35,"slug":36,"hasResults":37,"nctId":38,"briefTitle":39,"officialTitle":40,"acronym":26,"eligibilityCriteria":41,"healthyVolunteers":37,"sex":42,"minAge":43,"maxAge":44,"enrollmentInfo":45,"targetDuration":26,"studyType":48,"phases":49,"briefSummary":51,"conditions":52,"keywords":57,"overallStatus":60,"whyStopped":26,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":26},{"fullName":5,"class":6},"Assiut University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Modified Mallampati Only","ACTIVE_COMPARATOR","Adult elective surgical patients will undergo standard preoperative airway assessment using the modified Mallampati score only. No airway ultrasound will be performed. An experienced anesthesiologist, blinded to all preoperative assessments, will perform direct laryngoscopy for tracheal intubation and record the Cormack-Lehane grade on first attempt.",[13],"Diagnostic Test: Clinical Airway Assessment With Modified Mallampati Score",{"label":15,"type":16,"description":17,"interventionNames":18},"Mallampati Plus Ultrasound Skin-to-Epiglottis Distance","EXPERIMENTAL","Adult elective surgical patients will undergo standard preoperative airway assessment with the modified Mallampati score plus point-of-care airway ultrasound to measure the midline skin-to-epiglottis distance using a high-frequency linear probe at the thyrohyoid membrane. The measurement is non-invasive and does not change clinical management. An experienced anesthesiologist, blinded to both Mallampati and ultrasound results, will perform direct laryngoscopy for tracheal intubation and record the Cormack-Lehane grade on first attempt.",[19],"Diagnostic Test: Ultrasound-Guided Skin-to-Epiglottis Distance Measurement",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DIAGNOSTIC_TEST","Ultrasound-Guided Skin-to-Epiglottis Distance Measurement","Point-of-care airway ultrasound of the anterior neck using a high-frequency linear probe (10-13 MHz) placed transversely at the thyrohyoid membrane to measure the vertical skin-to-epiglottis distance in millimeters. The scan is performed preoperatively in supine neutral position, is non-invasive and painless, and does not alter anesthetic or airway management, which follow standard clinical practice. This measurement is combined with the modified Mallampati score in the experimental arm to predict difficult laryngoscopy (Cormack-Lehane grade 3-4).",[15],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Clinical Airway Assessment With Modified Mallampati Score","Standard preoperative bedside airway assessment using the modified Mallampati score without airway ultrasound; performed in the sitting position with mouth opening and maximal tongue protrusion, used routinely to anticipate difficulty of laryngoscopy.",[9],{"type":32,"investigatorFullName":33,"investigatorTitle":34,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","Mostafa Abdullah Badawy Abdullah","Resident at Anesthesia and ICU Department, Assiut University","100617179","combined-ultrasonographic-skin-to-epiglottis-distance-with-modified-mallampati-versus-modified-mallampati-score-alone-in-predicting-difficult-laryngoscopy-during-tracheal-intubation-under-general-anesthesia-100617179",false,"NCT07315256","Combined Ultrasonographic Skin-to-Epiglottis Distance With Modified Mallampati Versus Modified Mallampati Score Alone in Predicting Difficult Laryngoscopy During Tracheal Intubation Under General Anesthesia","Combined Ultrasonographic Skin-to-Epiglottis Distance With Modified Mallampati Versus Modified Mallampati Score Alone in Predicting Difficult Laryngoscopy During Tracheal Intubation Under General Anesthesia: A Prospective, Randomized Double Blinded Controlled Study","Inclusion Criteria:\n\n* Adults aged 18-65 years.\n* ASA physical status I-II.\n* Scheduled for elective surgery under general anesthesia requiring tracheal intubation with direct laryngoscopy.\n* Able to provide written informed consent.\n\nExclusion Criteria:\n\n* Emergency surgery.\n* Known or suspected difficult airway requiring planned alternative intubation technique (e.g., awake fiberoptic).\n* History of significant upper airway pathology, neck mass, prior neck surgery, or radiation affecting airway anatomy.\n* Limited mouth opening, cervical spine instability, or contraindication to standard sniffing position.\n* Pregnancy.\n* Refusal or inability to provide informed consent.","ALL","18 Years","65 Years",{"count":46,"type":47},160,"ESTIMATED","INTERVENTIONAL",[50],"NA","This study will evaluate how well an ultrasound measurement of the distance from the skin to the epiglottis, when combined with the modified Mallampati score, can predict difficult laryngoscopy in adult patients undergoing elective surgery under general anesthesia. Adult patients scheduled for surgery requiring tracheal intubation will be randomly assigned to two assessment strategies before anesthesia: one group will have the usual bedside airway assessment with modified Mallampati alone, and the other group will have modified Mallampati plus a quick, painless ultrasound scan of the front of the neck to measure the skin-to-epiglottis distance. During intubation, the anesthesiologist, who is blinded to the preoperative assessments, will grade the laryngoscopic view using the Cormack-Lehane classification, and the investigators will compare how accurately each assessment approach predicts difficult laryngoscopy (grade 3-4). The study does not change how anesthesia or airway management is performed; ultrasound and clinical assessments are added solely for measurement and data collection, with minimal risk to participants and potential future benefits in improving airway risk stratification and patient safety.",[53,54,55,56],"Ultrasonographic","Mallampati Score","Mallampati Score, Difficult Intubation, Videolaryngoscope","Tracheal Intubation",[58,56,59],"Difficult Laryngoscopy","Modified Mallampati","NOT_YET_RECRUITING","2025-12-18",{"date":63,"type":64},"2026-01-02","ACTUAL",{"date":66,"type":47},"2026-01",{"date":68,"type":47},"2027-02",{"name":5,"class":6}]