[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100657308":3},{"organization":4,"outcomesModule":7,"designInfo":62,"detailedDescription":70,"studyPopulation":61,"armGroups":71,"interventions":84,"overallOfficials":61,"centralContacts":92,"locations":61,"responsibleParty":98,"collaborators":61,"id":100,"slug":101,"hasResults":102,"nctId":103,"briefTitle":104,"officialTitle":105,"acronym":61,"eligibilityCriteria":106,"healthyVolunteers":102,"sex":107,"minAge":108,"maxAge":61,"enrollmentInfo":109,"targetDuration":61,"studyType":112,"phases":113,"briefSummary":115,"conditions":116,"keywords":118,"overallStatus":126,"whyStopped":61,"lastUpdateSubmitDate":127,"lastUpdatePostDateStruct":128,"startDateStruct":131,"completionDateStruct":133,"leadSponsor":135,"locationsCount":61},{"fullName":5,"class":6},"Hanoi Medical University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":61},[9],{"measure":10,"description":11,"timeFrame":12},"Oropharyngeal Leak Pressure (OLP)","Oropharyngeal leak pressure will be measured after successful placement of the assigned laryngeal mask and establishment of effective ventilation. OLP will be recorded in cmH2O as the airway pressure at which an audible oropharyngeal leak is detected during a standardized leak test.","Immediately after successful laryngeal mask placement, before the start of surgery",[14,18,22,26,29,32,36,39,43,47,51,54,58],{"measure":15,"description":16,"timeFrame":17},"First-attempt insertion success","Proportion of participants in whom effective ventilation is achieved after the first insertion attempt of the assigned laryngeal mask.","During initial laryngeal mask insertion",{"measure":19,"description":20,"timeFrame":21},"Overall insertion success","Proportion of participants in whom effective ventilation is achieved with the assigned laryngeal mask within the maximum number of insertion attempts permitted by the study protocol.","During laryngeal mask insertion, up to 3 attempts",{"measure":23,"description":24,"timeFrame":25},"Laryngeal mask insertion time","Time in seconds from introduction of the assigned laryngeal mask into the mouth until establishment of effective ventilation.","During laryngeal mask insertion",{"measure":27,"description":28,"timeFrame":25},"Number of insertion attempts","Number of attempts required to achieve successful placement and effective ventilation with the assigned laryngeal mask.",{"measure":30,"description":31,"timeFrame":25},"Need for additional airway maneuvers","Proportion of participants requiring additional maneuvers to achieve satisfactory placement and ventilation.",{"measure":33,"description":34,"timeFrame":35},"Peak inspiratory pressure","Peak inspiratory airway pressure measured in cmH2O during mechanical ventilation.","At 5 and 30 minutes after successful laryngeal mask placement",{"measure":37,"description":38,"timeFrame":35},"End-tidal carbon dioxide","End-tidal carbon dioxide (EtCO2) measured during mechanical ventilation.",{"measure":40,"description":41,"timeFrame":42},"Heart Rate","Heart rate will be recorded in beats per minute (bpm).","At baseline, immediately after successful laryngeal mask placement, and at 5 and 30 minutes after placement",{"measure":44,"description":45,"timeFrame":46},"Blood staining on the laryngeal mask","Presence of visible blood staining on the laryngeal mask after removal.","Immediately after device removal",{"measure":48,"description":49,"timeFrame":50},"Postoperative sore throat","Presence of patient-reported sore throat following general anesthesia.","At 1 and 24 hours after surgery",{"measure":52,"description":53,"timeFrame":50},"Postoperative hoarseness","Presence of patient-reported hoarseness following general anesthesia.",{"measure":55,"description":56,"timeFrame":57},"Airway-related adverse events","Occurrence of airway-related adverse events, including laryngospasm and clinically evident regurgitation.","From laryngeal mask insertion through postoperative observation, assessed up to 24 hours after surgery",{"measure":59,"description":60,"timeFrame":42},"Arterial Pressure","Arterial pressure will be recorded in mmHg.",null,{"allocation":63,"interventionModel":64,"interventionModelDescription":61,"primaryPurpose":6,"observationalModel":61,"timePerspective":61,"maskingInfo":65},"RANDOMIZED","PARALLEL",{"masking":66,"maskingDescription":67,"whoMasked":68},"SINGLE","Participants will be unaware of the assigned laryngeal mask device. The anesthesiologist performing device insertion and intraoperative outcome assessment cannot be masked because of the visible differences between the two devices.",[69],"PARTICIPANT","The SafeLM is a video-assisted laryngeal mask that allows visualization during placement, whereas the LMA Classic is a conventional supraglottic airway device. This study is designed to compare the clinical performance of these two devices under standardized conditions.\n\nAdult patients scheduled for elective fibroadenoma excision under general anesthesia will be screened for eligibility. Only patients for whom both devices are considered clinically appropriate will be enrolled, thereby avoiding randomization when patient characteristics indicate a preference for a particular airway management technique. Eligible participants will be randomly assigned to airway management with either the SafeLM or the LMA Classic.\n\nAfter standardized induction of general anesthesia, the assigned laryngeal mask will be inserted according to the study protocol. The primary outcome is oropharyngeal leak pressure after successful placement. Device insertion characteristics, ventilation parameters, hemodynamic responses, and airway-related adverse events will also be evaluated.",[72,78],{"label":73,"type":74,"description":75,"interventionNames":76},"SafeLM Video Laryngeal Mask","EXPERIMENTAL","Participants randomized to this arm will receive airway management with the SafeLM video laryngeal mask during general anesthesia for elective fibroadenoma excision. The device will be inserted according to the standardized study protocol.",[77],"Device: SafeLM Video Laryngeal Mask",{"label":79,"type":80,"description":81,"interventionNames":82},"LMA Classic","ACTIVE_COMPARATOR","Participants randomized to this arm will receive airway management with the LMA Classic during general anesthesia for elective fibroadenoma excision. The device will be inserted according to the standardized study protocol.",[83],"Device: LMA Classic",[85,89],{"type":86,"name":73,"description":87,"armGroupLabels":88,"otherNames":61},"DEVICE","The SafeLM is a video-assisted supraglottic airway device that allows visualization of the laryngeal structures during insertion and positioning. It will be used for airway management during general anesthesia according to the standardized study protocol.",[73],{"type":86,"name":79,"description":90,"armGroupLabels":91,"otherNames":61},"The LMA Classic is a conventional supraglottic airway device without video guidance. It will be used for airway management during general anesthesia according to the standardized study protocol.",[79],[93],{"name":94,"role":95,"phone":96,"phoneExt":61,"email":97},"Hung T. Tran, MD","CONTACT","+84367378519","thanhhungvt@gmail.com",{"type":99,"investigatorFullName":61,"investigatorTitle":61,"investigatorAffiliation":61,"oldNameTitle":61,"oldOrganization":61},"SPONSOR","100657308","safelm-versus-lma-classic-for-airway-management-during-fibroadenoma-excision-100657308",false,"NCT07835750","SafeLM Versus LMA Classic for Airway Management During Fibroadenoma Excision","Comparison of Airway Control Effectiveness of the SafeLM Video Laryngeal Mask and the LMA Classic in Patients Undergoing General Anesthesia for Fibroadenoma Excision","Inclusion Criteria:\n\n* Female patients aged 18 years or older.\n* Scheduled for elective excision of benign breast fibroadenoma under general anesthesia.\n* Planned airway management with a laryngeal mask airway.\n* American Society of Anesthesiologists (ASA) physical status I-II.\n* Both the SafeLM and LMA Classic are considered clinically appropriate for airway management.\n* Provision of written informed consent.\n\nExclusion Criteria:\n\n* Increased risk of pulmonary aspiration, including inadequate preoperative fasting, full stomach, or gastrointestinal obstruction.\n* Known or suspected difficult airway or other airway characteristics for which random allocation between the two study devices is considered clinically inappropriate.\n* Upper airway pathology or anatomical abnormality that may interfere with laryngeal mask placement.\n* Clinical or surgical indication requiring tracheal intubation rather than a laryngeal mask airway.\n* Contraindication or known allergy to medications used in the standardized anesthesia protocol.\n* Inability to provide informed consent.","FEMALE","18 Years",{"count":110,"type":111},132,"ESTIMATED","INTERVENTIONAL",[114],"NA","This randomized controlled trial compares the airway management performance of the SafeLM video laryngeal mask with the LMA Classic in adult patients undergoing elective fibroadenoma excision under general anesthesia. Participants will be randomly assigned to airway management with either the SafeLM or the LMA Classic. The primary outcome is oropharyngeal leak pressure. Secondary outcomes include insertion performance, ventilation parameters, hemodynamic responses, and airway-related adverse events.",[117],"Airway Management",[119,120,121,79,122,123,124,125],"Laryngeal Mask Airway","Video Laryngeal Mask","SafeLM","Oropharyngeal Leak Pressure","Supraglottic Airway Device","General Anesthesia","Fibroadenoma Excision","NOT_YET_RECRUITING","2026-10-02",{"date":129,"type":130},"2026-10-07","ACTUAL",{"date":132,"type":111},"2026-10",{"date":134,"type":111},"2027-07",{"name":5,"class":6}]