[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100606594":3},{"organization":4,"outcomesModule":7,"designInfo":64,"detailedDescription":69,"studyPopulation":63,"armGroups":70,"interventions":83,"overallOfficials":97,"centralContacts":102,"locations":108,"responsibleParty":134,"collaborators":137,"id":161,"slug":63,"hasResults":162,"nctId":163,"briefTitle":164,"officialTitle":165,"acronym":63,"eligibilityCriteria":166,"healthyVolunteers":162,"sex":167,"minAge":168,"maxAge":169,"enrollmentInfo":170,"targetDuration":63,"studyType":173,"phases":174,"briefSummary":176,"conditions":177,"keywords":179,"overallStatus":111,"whyStopped":63,"lastUpdateSubmitDate":182,"lastUpdatePostDateStruct":183,"startDateStruct":186,"completionDateStruct":188,"leadSponsor":190,"locationsCount":191},{"fullName":5,"class":6},"First Affiliated Hospital of Zhejiang University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":63},[9],{"measure":10,"description":11,"timeFrame":12},"Success rate of anatomical alignment of laryngeal mask","Comparison of anatomical positioning success rates between inflatable LMA and GMA-Tulip LMA, assessed by fiberoptic bronchoscopy (FOB).","During LMA placement (immediately after insertion)",[14,18,22,25,29,33,37,41,45,49,53,55,59],{"measure":15,"description":16,"timeFrame":17},"Sealing pressure and positional stability of the GMA-Tulip versus inflatable LMA","Assess the stability and anti-displacement properties of special body positions (e.g. lateral decubitus, Trendelenburg position) and the laryngeal mask airway under pneumoperitoneum.","Intraoperative period (from LMA insertion until removal at end of surgery)",{"measure":19,"description":20,"timeFrame":21},"First-attempt success rate of LMA","First-attempt success: Successful placement of the laryngeal mask airway on the first attempt without requiring reinsertion","during procedure",{"measure":23,"description":24,"timeFrame":21},"Time to Successful Placement of LMA","Duration (in seconds) from LMA insertion into the oral cavity until final correct positioning is achieved",{"measure":26,"description":27,"timeFrame":28},"Hemodynamic response to LMA insertion and removal","Parameters: Systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial pressure (MAP) (measured non-invasively or invasively).","Intraoperative period",{"measure":30,"description":31,"timeFrame":32},"Oxygenation Stability (Intraoperative)","Peripheral oxygen saturation (SpO₂) (%) measured by continuous pulse oximetry","From patient entry into operating room to the time for LMA removal",{"measure":34,"description":35,"timeFrame":36},"Ventilation Parameters (Intraoperative)","The measurement of Peak Airway Pressure (Ppeak) in cmH₂O is typically obtained through real-time monitoring by the anesthesia machine's ventilator system.","from the start of mechanical ventilation after LMA placement to LMA removal",{"measure":38,"description":39,"timeFrame":40},"Feasibility of gastric tube insertion through LMA","Success rate: Proportion of cases with successful gastric tube placement","During LMA placement (after confirmation of correct LMA position).",{"measure":42,"description":43,"timeFrame":44},"LMA-Related Complications","Immediate complications: Visible blood on removal (graded: none\u002Fmild\u002Fmoderate\u002Fsevere), sore throat , hoarseness, aspiration.\n\nPain assessment: NRS for sore throat .","Day 0",{"measure":46,"description":47,"timeFrame":48},"Patient Tolerance Score","Grade I (Excellent Tolerance) to Grade IV (Severe Intolerance)","Within 60 minutes after LMA removal",{"measure":50,"description":51,"timeFrame":52},"Anesthesiologist Satisfaction Survey","Scale: 1-10 (1 = Very dissatisfied, 10 = Very satisfied)","Within 30 minutes after surgery completion",{"measure":54,"description":51,"timeFrame":52},"Surgeon Satisfaction Assessment",{"measure":56,"description":57,"timeFrame":58},"Patient Satisfaction Survey","Scale: 1-10 (1 = Very uncomfortable, 10 = Very comfortable)","Within 24 hours after surgery",{"measure":60,"description":61,"timeFrame":62},"Ultrasonographic Assessment of Gastric Antrum Cross-Sectional Area (CSA) in Supine Position for Monitoring Gastric Insufflation","This protocol utilizes point-of-care ultrasound (POCUS) to measure gastric antrum cross-sectional area (CSA) in supine patients, evaluating the risk of perioperative gastric insufflation caused by LMA.","Baseline: Within 10 minutes before anesthesia induction; Post-intervention: Within 3 minutes after successful LMA placement; Postoperative: After surgical closure but before LMA removal",null,{"allocation":65,"interventionModel":66,"interventionModelDescription":63,"primaryPurpose":6,"observationalModel":63,"timePerspective":63,"maskingInfo":67},"RANDOMIZED","PARALLEL",{"masking":68,"maskingDescription":63,"whoMasked":63},"NONE","Eligible patients meeting the inclusion criteria were enrolled in the study and randomly assigned into two groups using a random number table: the traditional Inflatable Laryngeal Mask Airway Group (Group L) and the GMA Group (Group G). One day before surgery, the research team conducted preliminary screening of patients scheduled for elective surgery, followed by a preoperative visit to explain the study's purpose, anesthesia considerations, and obtain informed consent. Upon entering the operating room, standard monitoring (ECG, blood pressure, pulse oximetry, etc.) was applied. The research team recorded the patient's actual fasting duration, last intake (food\u002Fliquid type), and baseline characteristics, including age, sex, height, weight, BMI, comorbidities, ASA classification, surgical type, and preoperative anxiety level. Airway assessment was reconfirmed. Anesthesia induction was performed with intravenous etomidate, vecuronium, and sufentanil. After loss of consciousness and disappearance of the eyelash reflex, manual ventilation was initiated. Following induction, the laryngeal mask was inserted.",[71,77],{"label":72,"type":73,"description":74,"interventionNames":75},"Inflatable LMA Group","ACTIVE_COMPARATOR","Patients in this group will receive airway management using the standard inflatable LMA (Laryngeal Mask Airway) during general anesthesia. The device will be inserted according to manufacturer guidelines, and sealing pressure, insertion success rate, and ventilation efficacy will be recorded.",[76],"Device: Inflatable Laryngeal Mask Airway",{"label":78,"type":79,"description":80,"interventionNames":81},"GMA Group","EXPERIMENTAL","Patients in this group will receive airway management using the GMA-Tulip LMA, a modified supraglottic airway device. Insertion technique and outcome measurements (e.g., sealing pressure, ventilation parameters) will be recorded.",[82],"Device: GMA Laryngeal Mask Airway",[84,91],{"type":85,"name":86,"description":87,"armGroupLabels":88,"otherNames":89},"DEVICE","GMA Laryngeal Mask Airway","The GMA-Tulip is a new single-use supraglottic airway device (SAD). Device size is selected based on the patient's weight and height, following manufacturer guidelines.",[78],[90],"GMA-Tulip LMA",{"type":85,"name":92,"description":93,"armGroupLabels":94,"otherNames":95},"Inflatable Laryngeal Mask Airway","The comparator is a conventional inflatable Laryngeal Mask Airway (LMA) of appropriate size (selected by weight\u002Fheight), inserted using standard clinical protocols.",[72],[96],"Cuffed Supraglottic Airway",[98],{"name":99,"affiliation":100,"role":101},"Xiangming Fang","Zhejiang University","PRINCIPAL_INVESTIGATOR",[103],{"name":104,"role":105,"phone":106,"phoneExt":63,"email":107},"Xiangming Fang, Doctor","CONTACT","8613867161019","xmfang@zju.edu.cn",[109],{"facility":110,"status":111,"city":112,"state":113,"zip":114,"country":115,"countryCode":116,"cosmosGeoPoint":117,"geoPoint":122,"contacts":123},"The First affiliated Hospital, School of Medicine, Zhejiang University","RECRUITING","Hangzhou","Zhejiang","310000","China","CN",{"type":118,"coordinates":119},"Point",[120,121],120.16142,30.29365,{"lat":121,"lon":120},[124,128,132],{"name":125,"role":105,"phone":126,"phoneExt":63,"email":127},"Bingduo Wang, M.D.","8615067607819","1323183@zju.edu.cn",{"name":129,"role":105,"phone":130,"phoneExt":63,"email":131},"Xiaoxia An, M.D.","8613858180512","anxxls@163.com",{"name":133,"role":101,"phone":63,"phoneExt":63,"email":63},"Xiangming Fang, M.D.",{"type":101,"investigatorFullName":135,"investigatorTitle":136,"investigatorAffiliation":5,"oldNameTitle":63,"oldOrganization":63},"xiangming fang","Director, Head of Anesthesiology and Critical Care, Principal Investigator, Professor",[138,140,142,144,146,149,151,153,155,157,159],{"name":139,"class":6},"The Second Affiliated Hospital of Zhejiang Chinese Medical University",{"name":141,"class":6},"Red Cross Hospital, Hangzhou, China",{"name":143,"class":6},"Hangzhou Hospital of Traditional Chinese Medicine",{"name":145,"class":6},"Lanxi People's Hospital",{"name":147,"class":148},"Ningbo Medical Center Lihuili Hospital","OTHER_GOV",{"name":150,"class":6},"The Second Affiliated Hospital of Jiaxing University",{"name":152,"class":6},"Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University",{"name":154,"class":6},"Ruijin Hospital",{"name":156,"class":6},"The Central Hospital of Lishui City",{"name":158,"class":6},"Lishui Country People's Hospital",{"name":160,"class":6},"Sir Run Run Shaw Hospital","100606594",false,"NCT07177586","New-Generation GMA Laryngeal Mask Airway Versus Conventional Inflatable Laryngeal Mask Airway","A Multicenter, Randomized Controlled Study Comparing the Effectiveness of the New Generation GMA Laryngeal Mask and Conventional Laryngeal Mask in Airway Management During General Anesthesia","Inclusion Criteria:\n\n* Inclusion Criteria\n\n  1. Age 18-75 years;\n  2. ASA physical status I-II;\n  3. Strict compliance with ASA fasting guidelines;\n  4. Normal airway anatomy;\n  5. Voluntary participation with signed informed consent.\n* Exclusion Criteria:\n\n  1. Pre-existing aspiration risk or gastrointestinal disorders;\n  2. Oropharyngeal\u002Flaryngeal abnormalities;\n  3. Anticipated difficult airway (≥1 of the following):\n\n     BMI \\>30 kg\u002Fm² Mouth opening \\\u003C3 cm Mallampati class III-IV Restricted neck mobility\n  4. Contraindications to LMA use;\n  5. Communication or cognitive impairments;\n  6. Other exclusions at investigator's discretion","ALL","18 Years","75 Years",{"count":171,"type":172},1384,"ESTIMATED","INTERVENTIONAL",[175],"NA","This study aims to compare the new-generation GMA laryngeal mask airway (LMA) with the traditional inflatable LMA in patients undergoing elective surgery under general anesthesia. The primary objectives are to evaluate the safety, effectiveness, stability, ease of use, and patient comfort of the GMA LMA, providing practical guidance for clinical airway management. Additionally, this research will analyze the anatomical positioning and sealing mechanism of the LMA to identify factors influencing proper alignment and airway sealing. The findings may contribute to future improvements in LMA design, enhancing patient safety and procedural success.\n\nThis study is designed for healthcare providers, anesthesiologists, and researchers seeking evidence-based recommendations for LMA selection in clinical practice. Participation involves standard anesthesia procedures with close monitoring to ensure patient safety.",[178],"Supraglottic Airway Devices Position",[180,181],"supraglottic airway device","laryngeal mask","2026-02-02",{"date":184,"type":185},"2026-02-04","ACTUAL",{"date":187,"type":185},"2025-09-18",{"date":189,"type":172},"2027-07-31",{"name":5,"class":6},1]