[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100630035":3},{"organization":4,"outcomesModule":7,"designInfo":41,"detailedDescription":48,"studyPopulation":40,"armGroups":49,"interventions":68,"overallOfficials":40,"centralContacts":87,"locations":93,"responsibleParty":111,"collaborators":40,"id":115,"slug":40,"hasResults":116,"nctId":117,"briefTitle":118,"officialTitle":119,"acronym":40,"eligibilityCriteria":120,"healthyVolunteers":116,"sex":121,"minAge":122,"maxAge":40,"enrollmentInfo":123,"targetDuration":40,"studyType":126,"phases":127,"briefSummary":129,"conditions":130,"keywords":132,"overallStatus":96,"whyStopped":40,"lastUpdateSubmitDate":137,"lastUpdatePostDateStruct":138,"startDateStruct":141,"completionDateStruct":143,"leadSponsor":145,"locationsCount":146},{"fullName":5,"class":6},"Trabzon Kanuni Education and Research Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":17,"otherOutcomes":40},[9,13],{"measure":10,"description":11,"timeFrame":12},"Prediction of difficult tracheal intubation","Airway ultrasonographic parameters and conventional airway assessment scores will be evaluated to determine their ability to predict difficult tracheal intubation in obese patients undergoing elective surgery under general anesthesia. Difficult tracheal intubation will be defined using the Intubation Difficulty Scale (IDS).","Periprocedural (during tracheal intubation)",{"measure":14,"description":15,"timeFrame":16},"Tracheal intubation success according to laryngoscope type","Tracheal intubation success will be compared among patients randomized to Macintosh laryngoscope, Tuoren videolaryngoscope, and Besdata videolaryngoscope during tracheal intubation in obese patients undergoing elective surgery under general anesthesia.","During the tracheal intubation procedure",[18,21,24,28,32,36],{"measure":19,"description":20,"timeFrame":12},"Glottic visualization time","Glottic visualization time will be defined as the time from passage of the laryngoscope blade past the lips until the first visualization of the vocal cords during laryngoscopy. Glottic visualization time will be compared among the Macintosh laryngoscope, Tuoren videolaryngoscope, and Besdata videolaryngoscope groups.",{"measure":22,"description":23,"timeFrame":12},"Endotracheal intubation time","Endotracheal intubation time will be defined as the time from passage of the laryngoscope blade past the lips until confirmation of successful tracheal intubation by capnography. Intubation time will be compared among the Macintosh laryngoscope, Tuoren videolaryngoscope, and Besdata videolaryngoscope groups.",{"measure":25,"description":26,"timeFrame":27},"Hemodynamic response to tracheal intubation","Hemodynamic parameters will be recorded before anesthesia induction, 1 minute after induction, at 1, 3, 5, and 10 minutes after tracheal intubation, and immediately before extubation to evaluate the effects of different laryngoscopy techniques.","Periprocedural",{"measure":29,"description":30,"timeFrame":31},"Postoperative airway ultrasonographic measurements","Airway ultrasonography will be repeated 30 minutes after extubation in the recovery unit and compared with preoperative ultrasonographic measurements.","30 minutes after extubation",{"measure":33,"description":34,"timeFrame":35},"Airway-related postoperative complications","Airway-related complications including sore throat, hoarseness, laryngospasm, bronchospasm, hypoxemia, esophageal intubation, and oral trauma will be recorded.","From intubation to 30 minutes postoperatively",{"measure":37,"description":38,"timeFrame":39},"Anesthesiologist satisfaction score","Anesthesiologist satisfaction with the laryngoscope will be evaluated using a 6-item questionnaire based on a 5-point Likert scale (1 = very poor, 5 = excellent). The questionnaire will assess the ease of laryngoscope insertion, quality of glottic visualization, ease of endotracheal tube placement, device handling, need for additional maneuvers, and overall operator satisfaction.","Immediately after tracheal intubation",null,{"allocation":42,"interventionModel":43,"interventionModelDescription":44,"primaryPurpose":45,"observationalModel":40,"timePerspective":40,"maskingInfo":46},"RANDOMIZED","PARALLEL","Participants will be randomized into three parallel groups to undergo tracheal intubation using either a Macintosh laryngoscope, Tuoren videolaryngoscope, or Besdata videolaryngoscope. Each participant will receive only one assigned intervention.","DIAGNOSTIC",{"masking":47,"maskingDescription":40,"whoMasked":40},"NONE","Unanticipated morbidity related to difficult airway management remains a major concern for anesthesiologists. One of the primary reasons is the high interobserver variability and limited predictive power of currently used bedside airway assessment tests. The use of more objective and reproducible measurement techniques may improve intubation success rates and allow better preparation in cases of anticipated difficult airway.\n\nUltrasonography (USG) is a rapid, non-invasive, portable imaging modality that provides both static and dynamic real-time visualization. Airway ultrasonography is increasingly used in operating rooms, intensive care units, and emergency departments for detailed assessment of airway anatomy. It provides valuable information regarding upper airway structures, soft tissues of the head and neck, and pretracheal anatomy.\n\nPreoperative airway assessment is the first and most critical step in preventing anesthesia-related airway complications. Recent evidence suggests that incorporating airway ultrasound into routine pre-anesthetic evaluation may improve the prediction of difficult airway compared to conventional clinical assessments alone.\n\nWith the global increase in obesity prevalence, anesthesiologists are encountering a growing number of obese patients in daily practice. Numerous studies have identified male sex, advanced age, increased neck circumference, higher body mass index (BMI), obstructive sleep apnea syndrome, higher Mallampati score, higher ASA score, and shorter thyromental distance as predictors of difficult intubation in obese patients. Despite these known predictors, the rate of unanticipated difficult intubation remains considerable.\n\nVideolaryngoscopes have demonstrated high success rates in both anticipated and unanticipated difficult airway scenarios. These devices improve glottic visualization and may increase first-pass intubation success while reducing airway-related complications. In obese patients, videolaryngoscopy may further enhance intubation safety and perioperative outcomes.\n\nThis randomized prospective study aims to compare the predictive value of conventional difficult airway markers (Mallampati score, thyromental distance, sternomental distance, and neck circumference) with airway ultrasonographic parameters (vocal cord mobility, glottic opening, hyomental distance, skin-to-epiglottis distance, and peri-epiglottic space-epiglottis-vocal cord ratio) in obese patients undergoing elective surgery under general anesthesia.\n\nAdditionally, the study will evaluate the effects of three different laryngoscopy methods (Macintosh direct laryngoscope, Tuoren videolaryngoscope, and Besdata videolaryngoscope) on intubation success, perioperative respiratory complications, and hemodynamic responses. Postoperative airway ultrasonography will be performed to assess potential airway-related complications.",[50,57,62],{"label":51,"type":52,"description":53,"interventionNames":54},"Besdata Videolaryngoscope","EXPERIMENTAL","Participants randomized to this arm will undergo tracheal intubation using the Besdata videolaryngoscope under standardized general anesthesia induction.",[55,56],"Procedure: Airway ultrasonography","Device: Besdata Videolaryngoscope Intubation",{"label":58,"type":52,"description":59,"interventionNames":60},"Tuoren Videolaryngoscope","Participants randomized to this arm will undergo tracheal intubation using the Tuoren videolaryngoscope under standardized general anesthesia induction.",[55,61],"Device: Tuoren Videolaryngoscope Intubation",{"label":63,"type":64,"description":65,"interventionNames":66},"Macintosh Laryngoscope","ACTIVE_COMPARATOR","Participants randomized to this arm will undergo tracheal intubation using a conventional Macintosh direct laryngoscope under standardized general anesthesia induction.",[55,67],"Device: Macintosh Laryngoscope Intubation",[69,74,79,83],{"type":70,"name":71,"description":72,"armGroupLabels":73,"otherNames":40},"PROCEDURE","Airway ultrasonography","Preoperative airway ultrasonography will be performed in the waiting area before surgery to evaluate upper airway structures including vocal cord mobility, glottic opening, hyomental distance, skin-to-epiglottis distance, and peri-epiglottic space-epiglottis-vocal cord ratio. Measurements will be obtained with a Mindray Consona N7 ultrasound device while the patient is in the supine position. Each measurement will be performed three times and the average value will be recorded. Postoperative airway ultrasonography will be repeated at 30 minutes in the recovery unit.",[51,63,58],{"type":75,"name":76,"description":77,"armGroupLabels":78,"otherNames":40},"DEVICE","Macintosh Laryngoscope Intubation","Endotracheal intubation will be performed using a conventional Macintosh direct laryngoscope under standardized general anesthesia induction.",[63],{"type":75,"name":80,"description":81,"armGroupLabels":82,"otherNames":40},"Tuoren Videolaryngoscope Intubation","Endotracheal intubation will be performed using the Tuoren videolaryngoscope under standardized general anesthesia induction.",[58],{"type":75,"name":84,"description":85,"armGroupLabels":86,"otherNames":40},"Besdata Videolaryngoscope Intubation","Endotracheal intubation will be performed using the Besdata videolaryngoscope under standardized general anesthesia induction.",[51],[88],{"name":89,"role":90,"phone":91,"phoneExt":40,"email":92},"Ezgi Günaydın, MD","CONTACT","+905336834198","ezgunaydin@gmail.com",[94],{"facility":95,"status":96,"city":97,"state":40,"zip":98,"country":99,"countryCode":40,"cosmosGeoPoint":100,"geoPoint":105,"contacts":106},"Trabzon University Faculty of Medicine Kanuni Training and Research Hospital","RECRUITING","Trabzon","61040","Turkey (Türkiye)",{"type":101,"coordinates":102},"Point",[103,104],39.72694,41.005,{"lat":104,"lon":103},[107],{"name":108,"role":90,"phone":109,"phoneExt":40,"email":110},"Recep Erin, doctor","+905304699135","erinrecep@gmail.com",{"type":112,"investigatorFullName":113,"investigatorTitle":114,"investigatorAffiliation":5,"oldNameTitle":40,"oldOrganization":40},"PRINCIPAL_INVESTIGATOR","Ezgi Günaydın","research assistant","100630035",false,"NCT07482436","Comparison of Airway Ultrasonography and Laryngoscopy Methods in Obese Patients","The Effect of Preoperative and Postoperative Airway Ultrasonography and Different Laryngoscope Uses on Intubation Success and Postoperative Complications in Obese Patients","Inclusion Criteria:\n\n* Patients who have given their consent\n* Patients who underwent surgery under general anesthesia\n* Patients over eighteen years of age\n* Patients with an American Society of Anesthesiologists (ASA) physical status classification of I-II-III\n* Patients with a body mass index (BMI) of 30 kg\u002Fm2 or higher\n* Patients whose surgery lasts between 60 and 150 minutes\n* Patients who underwent surgery under elective conditions will be included.\n\nExclusion Criteria:\n\n* Patients who do not consent,\n* those undergoing head and neck surgery,\n* those to be operated on in the prone position,\n* uncooperative patients (patients with whom communication is not possible),\n* those with craniofacial anomalies,\n* patients operated on in emergency situations will be excluded from the study.","ALL","18 Years",{"count":124,"type":125},180,"ESTIMATED","INTERVENTIONAL",[128],"NA","The main objective of this study was to examine the relationship between classical markers used in assessing difficult airway management in obese patients (Mallampati score, thyromental distance, sternomental distance, neck circumference measurement) and ultrasonographic parameters (vocal cord mobility, glottic opening, hyomental distance, skin-epiglottic distance, and peri-epiglottic space-epiglottic-vocal cord ratio), to compare the effects of these parameters on predicting difficult intubation, and to investigate the effects of different laryngoscopy methods on intubation success and peroperative respiratory complications.\n\nThe secondary objective of the study is to investigate the effects of different laryngoscopy methods on hemodynamic responses to intubation. Participants' gender, age, height, weight, BMI, ASA physical status classification, smoking status, comorbidities, STOP-BANG and LEMON scores will be recorded. The glottic score percentage (POGO score), glottic visualization time, endotracheal intubation time, use of assistive maneuvers, and Intubation Difficulty Scale (IDS) parameters will be compared according to the laryngoscopy methods used.\n\nParticipants must meet the following criteria:\n\n* Consent given by the patient\n* Operated under general anesthesia\n* Over 18 years of age\n* American Society of Anesthesiologists (ASA) physical status classification I-II-III\n* Body mass index (BMI) of 30 kg\u002Fm2 or higher\n* Operation duration between 60-150 minutes\n* Patients undergoing elective surgery.",[131],"Correlation of Difficult Airway Markers With Ultrasonographic Measurements in Obese Patients",[133,134,135,136],"laryngoscopy","difficult airway","obese patients","airway ultrasonography","2026-03-14",{"date":139,"type":140},"2026-03-19","ACTUAL",{"date":142,"type":140},"2026-01-01",{"date":144,"type":125},"2026-07-01",{"name":5,"class":6},1]