[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659616":3},{"organization":4,"outcomesModule":7,"designInfo":56,"detailedDescription":67,"studyPopulation":55,"armGroups":68,"interventions":85,"overallOfficials":97,"centralContacts":101,"locations":106,"responsibleParty":131,"collaborators":134,"id":138,"slug":139,"hasResults":140,"nctId":141,"briefTitle":142,"officialTitle":143,"acronym":144,"eligibilityCriteria":145,"healthyVolunteers":140,"sex":146,"minAge":147,"maxAge":148,"enrollmentInfo":149,"targetDuration":55,"studyType":152,"phases":153,"briefSummary":155,"conditions":156,"keywords":160,"overallStatus":166,"whyStopped":55,"lastUpdateSubmitDate":167,"lastUpdatePostDateStruct":168,"startDateStruct":171,"completionDateStruct":173,"leadSponsor":175,"locationsCount":176},{"fullName":5,"class":6},"Masarykova Nemocnice v Usti nad Labem, Krajska Zdravotni a.s.","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":55},[9],{"measure":10,"description":11,"timeFrame":12},"Maximum Percentage Change in Mean Arterial Pressure From Baseline","Haemodynamic stress response to laryngeal mask insertion: maximum percentage change in mean arterial pressure (MAP) from the pre-insertion baseline value (measured under standardized anaesthesia at State Entropy 40-60) across the post-insertion measurement points. A between-group difference of 10% of baseline MAP is considered clinically relevant.","Baseline (before laryngeal mask insertion), immediately after insertion, and 5 and 10 minutes after insertion",[14,18,21,24,27,31,34,37,40,43,47,51],{"measure":15,"description":16,"timeFrame":17},"Postoperative Sore Throat Intensity","Intensity of sore throat assessed by the patient on a visual analogue scale (VAS, 0-100 mm; 0 = no pain, 100 = worst imaginable pain).","At discharge from the post-anaesthesia care unit (PACU) and 24 hours after laryngeal mask removal",{"measure":19,"description":20,"timeFrame":17},"Incidence of Postoperative Sore Throat","Presence of sore throat reported by the patient (yes\u002Fno).",{"measure":22,"description":23,"timeFrame":12},"Change in Heart Rate From Baseline","Heart rate (beats\u002Fmin) as a marker of the haemodynamic stress response to laryngeal mask insertion; change from the pre-insertion baseline value.",{"measure":25,"description":26,"timeFrame":17},"Incidence of Hoarseness","Presence of hoarseness (yes\u002Fno).",{"measure":28,"description":29,"timeFrame":30},"Blood Staining on the Laryngeal Mask","Presence of visible blood on the laryngeal mask at removal (yes\u002Fno).","At laryngeal mask removal up to 10 minutes from the removal",{"measure":32,"description":33,"timeFrame":30},"Coughing at Laryngeal Mask Removal","Coughing assessed with a coughing score (0 = none, 1 = mild, 2 = moderate, 3 = severe).",{"measure":35,"description":36,"timeFrame":17},"Incidence of Postoperative Nausea and Vomiting (PONV)","Presence of postoperative nausea and\u002For vomiting (yes\u002Fno).",{"measure":38,"description":39,"timeFrame":12},"Change in Surgical Pleth Index (SPI) From Baseline","Surgical Pleth Index (0-100) as an index of the nociceptive response to laryngeal mask insertion; change from the pre-insertion baseline value.",{"measure":41,"description":42,"timeFrame":12},"Change in the Response Entropy - State Entropy Difference From Baseline","Difference between Response Entropy (RE) and State Entropy (SE) as an index of frontal EMG activation in response to laryngeal mask insertion; change from the pre-insertion baseline value.",{"measure":44,"description":45,"timeFrame":46},"Number of Insertion Attempts","Number of attempts needed for successful laryngeal mask insertion.","During laryngeal mask insertion",{"measure":48,"description":49,"timeFrame":50},"Need for Airway Manipulation","Need for any additional airway manoeuvre (e.g. jaw thrust, head\u002Fneck repositioning, device repositioning or change of size) to achieve adequate ventilation (yes\u002Fno).","From laryngeal mask insertion until 10 minutes after insertion",{"measure":52,"description":53,"timeFrame":54},"Oropharyngeal Leak Pressure","Oropharyngeal leak pressure (cmH2O) measured after laryngeal mask insertion with cuff pressure adjusted to 40-50 cmH2O.","After laryngeal mask insertion and cuff pressure adjustment",null,{"allocation":57,"interventionModel":58,"interventionModelDescription":59,"primaryPurpose":60,"observationalModel":55,"timePerspective":55,"maskingInfo":61},"RANDOMIZED","PARALLEL","Two-centre, three parallel groups with 1:1:1 computer-generated random allocation to one of three laryngeal masks (SaCoVLM, LMA Supreme, Ambu AuraGain).","SUPPORTIVE_CARE",{"masking":62,"maskingDescription":63,"whoMasked":64},"DOUBLE","Patients are anaesthetized during device insertion and are not informed of the allocated device. Outcome assessors in the post-anaesthesia care unit and at the 24-hour follow-up are unaware of group allocation. The anaesthesiologist inserting the device cannot be blinded because the devices are visibly different.",[65,66],"PARTICIPANT","OUTCOMES_ASSESSOR","Design: prospective, randomized, controlled, parallel-group (1:1:1), two-centre trial (Masaryk Hospital Usti nad Labem and Decin Hospital, Krajska zdravotni, a.s., Czech Republic). Allocation is based on a computer-generated randomization sequence.\n\nParticipants: 162 adult patients (ASA physical status I-II) scheduled for elective surgery under general anaesthesia with a laryngeal mask airway, randomized to SaCoVLM, LMA Supreme or Ambu AuraGain (54 patients per group).\n\nBlinding: patients (anaesthetized during device insertion) and outcome assessors in the post-anaesthesia care unit and at the 24-hour follow-up are blinded to group allocation. The anaesthesiologist inserting the device cannot be blinded because the devices are visibly different.\n\nInvestigators: all devices are inserted by board-certified anaesthesiologists with at least 5 years of practice and more than 4,000 documented general anaesthetics.\n\nAnaesthesia protocol: standardized induction with sufentanil 0.3 ug\u002Fkg ideal body weight and propofol up to 3 mg\u002Fkg titrated to a State Entropy of 40-60. Depth of anaesthesia is maintained at a State Entropy of 40-60. No neuromuscular blocking agents are administered before or during the haemodynamic measurement period; they may be used later during surgery if required. Device size is selected according to the manufacturer's recommendations. After insertion, cuff pressure is measured with a manometer and adjusted to 40-50 cmH2O, below the manufacturers' maximum recommended pressure of 60 cmH2O.\n\nMeasurements: mean arterial pressure, heart rate, Surgical Pleth Index (SPI), State Entropy (SE) and Response Entropy (RE) are recorded before laryngeal mask insertion (baseline, at SE 40-60), immediately after insertion, and 5 and 10 minutes after insertion. The number of insertion attempts, need for airway manipulation and oropharyngeal leak pressure are recorded. After device removal, sore throat (VAS), hoarseness, blood staining of the device, coughing and postoperative nausea and vomiting are assessed until discharge from the post-anaesthesia care unit and at 24 hours.\n\nSample size: a between-group difference of 10% of baseline mean arterial pressure (MAP; approximately 8.2 mmHg at a baseline of 82 mmHg) was considered clinically relevant. The standard deviation of MAP after laryngeal mask insertion was estimated at 12 mmHg, derived from the systolic and diastolic blood pressures reported 5 minutes after LMA Supreme insertion (Iran Red Crescent Med J, doi:10.5812\u002Fircmj.28615) and consistent with the MAP variability reported by Montazari et al. (Acta Med Iran 2004;42:437-440). With a two-sided alpha of 0.0167 (Bonferroni correction for three pairwise comparisons) and 80% power, 47 patients per group are required; allowing for a 10% drop-out rate, 54 patients per group (162 in total) will be enrolled.",[69,75,80],{"label":70,"type":71,"description":72,"interventionNames":73},"SaCoVLM","ACTIVE_COMPARATOR","Patients in whom the airway is secured with the SaCoVLM video laryngeal mask; cuff pressure adjusted to 40-50 cmH2O (n = 54).",[74],"Device: SaCoVLM video laryngeal mask",{"label":76,"type":71,"description":77,"interventionNames":78},"LMA Supreme","Patients in whom the airway is secured with the LMA Supreme; cuff pressure adjusted to 40-50 cmH2O (n = 54).",[79],"Device: LMA Supreme",{"label":81,"type":71,"description":82,"interventionNames":83},"Ambu AuraGain","Patients in whom the airway is secured with the Ambu AuraGain; cuff pressure adjusted to 40-50 cmH2O (n = 54).",[84],"Device: Ambu AuraGain",[86,91,94],{"type":87,"name":88,"description":89,"armGroupLabels":90,"otherNames":55},"DEVICE","SaCoVLM video laryngeal mask","Airway secured with the SaCoVLM video laryngeal mask (second-generation supraglottic airway device with integrated video channel), inserted after induction of general anaesthesia according to the manufacturer's instructions.",[70],{"type":87,"name":76,"description":92,"armGroupLabels":93,"otherNames":55},"Airway secured with the LMA Supreme (second-generation supraglottic airway device), inserted after induction of general anaesthesia according to the manufacturer's instructions.",[76],{"type":87,"name":81,"description":95,"armGroupLabels":96,"otherNames":55},"Airway secured with the Ambu AuraGain (second-generation supraglottic airway device), inserted after induction of general anaesthesia according to the manufacturer's instructions.",[81],[98],{"name":99,"affiliation":5,"role":100},"Michal Kalina, MD, Ph.D., MBA","PRINCIPAL_INVESTIGATOR",[102],{"name":99,"role":103,"phone":104,"phoneExt":55,"email":105},"CONTACT","+420773628756","michal.kalina@kzcr.eu",[107,121],{"facility":108,"status":55,"city":109,"state":110,"zip":111,"country":112,"countryCode":55,"cosmosGeoPoint":113,"geoPoint":118,"contacts":119},"Nemocnice Decin, Krajska Zdravotni a.s.","Děčín","Ústí nad Labem Region","405 99","Czechia",{"type":114,"coordinates":115},"Point",[116,117],14.21478,50.78215,{"lat":117,"lon":116},[120],{"name":99,"role":103,"phone":104,"phoneExt":55,"email":105},{"facility":5,"status":55,"city":122,"state":110,"zip":123,"country":112,"countryCode":55,"cosmosGeoPoint":124,"geoPoint":128,"contacts":129},"Ústí nad Labem","401 13",{"type":114,"coordinates":125},[126,127],14.03227,50.6607,{"lat":127,"lon":126},[130],{"name":99,"role":103,"phone":104,"phoneExt":55,"email":105},{"type":100,"investigatorFullName":132,"investigatorTitle":133,"investigatorAffiliation":5,"oldNameTitle":55,"oldOrganization":55},"Michal Kalina","Principal Investigator",[135],{"name":136,"class":137},"Jan Evangelista Purkyne University in Usti nad Labem, Faculty of Health Studies","UNKNOWN","100659616","effect-of-laryngeal-mask-cuff-shape-on-pharyngeal-stress-100659616",false,"NCT07868848","Effect of Laryngeal Mask Cuff Shape on Pharyngeal Stress","Does the Shape of the Laryngeal Mask Airway Cuff Influence Pharyngeal Stress and the Haemodynamic Stress Response? A Prospective Randomized Three-Arm Trial","CUFFSTRESS","Inclusion Criteria:\n\n* Age 18-80 years\n* ASA physical status I-II\n* Scheduled for elective surgery under general anaesthesia with a laryngeal mask airway indicated\n* No history or predictors of difficult airway\n* Signed informed consent\n\nExclusion Criteria:\n\n* Refusal to sign informed consent\n* ASA physical status III or higher\n* Emergency surgery\n* Laparoscopic surgery\n* Surgery in the prone position\n* Head and neck surgery\n* Increased risk of pulmonary aspiration (e.g. gastro-oesophageal reflux disease, body mass index \\> 35 kg\u002Fm2)\n* Pre-existing sore throat, hoarseness or upper respiratory tract infection within the preceding 2 weeks","ALL","18 Years","80 Years",{"count":150,"type":151},162,"ESTIMATED","INTERVENTIONAL",[154],"NA","Laryngeal masks are widely used supraglottic airway devices, but their cuffs differ considerably in shape and design. The cuff exerts pressure on the pharyngeal structures, which may provoke a physiological stress response and contribute to postoperative pharyngeal complaints. This prospective, randomized, two-centre trial compares three commercially available laryngeal masks with different cuff designs (SaCoVLM, LMA Supreme and Ambu AuraGain) in 162 adult patients undergoing elective surgery under general anaesthesia. Anaesthesia induction is standardized and guided by State Entropy, and cuff pressure is standardized to 40-50 cmH2O in all groups. The primary outcome is the change in mean arterial pressure after laryngeal mask insertion. Secondary outcomes include heart rate, nociception and depth-of-anaesthesia indices (Surgical Pleth Index, Response Entropy - State Entropy difference), insertion characteristics, oropharyngeal leak pressure and postoperative pharyngolaryngeal complaints up to 24 hours. The hypothesis is that cuff shape modifies the stress exerted on the pharynx and thereby influences the patient's stress response.",[157,158,159],"Anesthesia, General","Airway Management","Postoperative Sore Throat",[161,162,163,164,165,70,76,81],"laryngeal mask airway","supraglottic airway device","cuff design","haemodynamic response","pharyngeal morbidity","NOT_YET_RECRUITING","2026-10-07",{"date":169,"type":170},"2026-10-09","ACTUAL",{"date":172,"type":151},"2026-10-01",{"date":174,"type":151},"2028-01-31",{"name":5,"class":6},2]