[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100613422":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":21,"locations":27,"responsibleParty":54,"collaborators":56,"id":58,"slug":59,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":62,"acronym":20,"eligibilityCriteria":63,"healthyVolunteers":64,"sex":65,"minAge":66,"maxAge":67,"enrollmentInfo":68,"targetDuration":20,"studyType":71,"phases":72,"briefSummary":74,"conditions":75,"keywords":20,"overallStatus":79,"whyStopped":20,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":89},{"fullName":5,"class":6},"National University of Malaysia","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Usage of SafeLM™ as the airway device","EXPERIMENTAL","SafeLM™ will be the airway device used for ventilation throughout the general anaesthesia period",[13],"Device: SafeLM™ as the airway management device during general anaesthesia",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","SafeLM™ as the airway management device during general anaesthesia","Appropriate size of SafeLM™ is selected for participants as manufacturer recommendation.\n\nSize 2 is for participants with body weight of 10-20 kg, recommended cuff volume to be inflated is 10 to 15 ml.\n\nSize 2.5 is for participants with body weight of 20-30 kg, recommended cuff volume to be inflated is 14 to 21 ml.\n\nSize 3 is for participants with body weight of 30-50 kg, recommended cuff volume to be inflated is 20 to 30 ml.\n\nSize 4 is for participants with body weight of 50-70 kg, recommended cuff volume to be inflated is 30 to 45 ml Size 5 is for participants with body weight of 70-100 kg, recommended cuff volume to be inflated is 40 to 60 ml.\n\nUnder general anaesthesia, the device is held by the anaesthesiologist at the distal end while advancing the laryngeal mask by sliding down the palatopharyngeal curve along the midline in the mouth until the end of the mask reach the hypopharynx cavity and resistance is met, under direct real-time visualisation.",[9],null,[22],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},"Rufinah Teo","CONTACT","+603-9145 5555","rufinah@hctm.ukm.edu.my",[28,40],{"facility":29,"status":20,"city":30,"state":31,"zip":32,"country":33,"countryCode":34,"cosmosGeoPoint":20,"geoPoint":20,"contacts":35},"Universiti Kebangsaan Malaysia","Cheras","Kuala Lumpur","56000","Malaysia","MY",[36,38],{"name":37,"role":24,"phone":25,"phoneExt":20,"email":26},"Rufinah Teo, Mb Bch BAO",{"name":37,"role":39,"phone":20,"phoneExt":20,"email":20},"PRINCIPAL_INVESTIGATOR",{"facility":41,"status":20,"city":31,"state":20,"zip":42,"country":33,"countryCode":34,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"University of Malaya","50603",{"type":44,"coordinates":45},"Point",[46,47],101.68653,3.1412,{"lat":47,"lon":46},[50],{"name":51,"role":24,"phone":52,"phoneExt":20,"email":53},"Ina Ismiarti Shariffuddin","+603-7967 3502","ismiarti@um.edu.my",{"type":55,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR",[57],{"name":41,"class":6},"100613422","clinical-efficacy-evaluation-of-supraglottic-airway-device-safelm-in-paediatric-population-100613422",false,"NCT07266389","Clinical Efficacy Evaluation of Supraglottic Airway Device SafeLM™ in Paediatric Population","Inclusion criteria\n\n* Patients who are scheduled for a surgery under general anaesthesia where supraglottic airway is deemed appropriate.\n* ASA I or II\n* Age up to 18 years old\n* Body weight of 10 kg and above\n\nExclusion criteria\n\n* Presence of risk of gastric regurgitation or aspiration\n* Recent upper respiratory tract infection within 2 weeks\n* Uncontrolled respiratory co-morbidity such as bronchial asthma, chronic lung disease, restrictive lung disease\n* Presence of congenital airway abnormalities\n* Patient or next of kins refusal in participating this study",true,"ALL","0 Years","18 Years",{"count":69,"type":70},60,"ESTIMATED","INTERVENTIONAL",[73],"NA","The goal of this interventional study is to evaluate the clinical efficacy of SafeLM™, a video laryngeal mask airway device in paediatric population. The main questions it aims to answer are:\n\n1. To determine the success rate, ease of device insertion, time for insertion, and how well the device seals the airway by measuring the oropharyngeal leak pressure (OPLP) of SafeLM™.\n2. To determine the incidence of complication associated with SafeLM™ usage.\n3. To study the association of glottic view with success rate and rate of complication.\n\nParticipants perioperative clinical data will be collected for data analysis.",[76,77,78],"Anesthesia","Supraglottic Airway Efficiency","Paediatric Airway Management","NOT_YET_RECRUITING","2025-11-24",{"date":82,"type":83},"2025-12-05","ACTUAL",{"date":85,"type":70},"2025-12-02",{"date":87,"type":70},"2026-05-30",{"name":5,"class":6},2]