[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100657848":3},{"organization":4,"outcomesModule":7,"designInfo":30,"detailedDescription":33,"studyPopulation":34,"armGroups":35,"interventions":29,"overallOfficials":42,"centralContacts":46,"locations":51,"responsibleParty":62,"collaborators":29,"id":66,"slug":67,"hasResults":68,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":29,"eligibilityCriteria":72,"healthyVolunteers":68,"sex":73,"minAge":74,"maxAge":29,"enrollmentInfo":75,"targetDuration":29,"studyType":78,"phases":29,"briefSummary":79,"conditions":80,"keywords":83,"overallStatus":86,"whyStopped":29,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":96},{"fullName":5,"class":6},"Kayseri City Hospital","OTHER_GOV",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":29},[9],{"measure":10,"description":11,"timeFrame":12},"Proportion of Patients With Initial Endotracheal Tube Cuff Pressure Within 20-30 cmH2O","Percentage of patients whose initial endotracheal tube cuff pressure, measured with a cuff manometer after intubation and initial cuff inflation and before any corrective adjustment, is between 20 and 30 cmH2O inclusive. The proportion will be compared between the pre-training and post-training cohorts. Measurements are performed by researchers independent of the clinical team, who learn the cuff inflation technique only after recording cuff pressure. This binary outcome is the basis of the sample-size calculation.","Immediately after endotracheal intubation and initial cuff inflation, before corrective pressure adjustment, during the index surgical procedure.",[14,17,21,25],{"measure":15,"description":16,"timeFrame":12},"Initial Endotracheal Tube Cuff Pressure","Initial cuff pressure measured with a cuff manometer in cmH2O before corrective adjustment, analyzed as a continuous variable and compared between the pre-training and post-training cohorts. The researcher learns the cuff inflation technique only after recording the measurement.",{"measure":18,"description":19,"timeFrame":20},"Proportion of Patients With Endotracheal Tube Cuff Leakage","Percentage of patients with cuff leakage, recorded as present or absent based on information from the treating anesthesia team during initial cuff inflation and assessment. The proportion will be compared between the pre-training and post-training cohorts.","During initial cuff inflation and assessment after endotracheal intubation in the index surgical procedure.",{"measure":22,"description":23,"timeFrame":24},"Proportion of Patients Requiring Additional Air for Cuff Inflation","Percentage of patients requiring additional air after initial cuff inflation, recorded as yes or no based on information from the treating anesthesia team. The proportion will be compared between the pre-training and post-training cohorts.","Periprocedural",{"measure":26,"description":27,"timeFrame":28},"Proportion of Patients With Postoperative Sore Throat","Percentage of patients reporting sore throat when questioned after extubation during postoperative recovery, once awake and able to answer questions. Sore throat is recorded as present or absent and compared between the pre-training and post-training cohorts.","At the first postoperative assessment after extubation when the patient is awake and able to answer questions, during recovery from the index surgical procedure.",null,{"allocation":29,"interventionModel":29,"interventionModelDescription":29,"primaryPurpose":29,"observationalModel":31,"timePerspective":32,"maskingInfo":29},"COHORT","PROSPECTIVE","This is a prospective, single-center observational before-and-after study in the operating rooms of Kayseri City Hospital. Consecutive eligible adult patients undergoing general anesthesia with endotracheal intubation will be observed in two temporal cohorts: a two-week pre-training cohort and a two-week post-training cohort. Only the first surgical procedure for each patient will be included.\n\nBetween the observation periods, anesthesia physicians and anesthesia technicians will receive standardized theoretical and practical education on cuff pressure management and the loss-of-resistance syringe technique. The education covers the target pressure range, the consequences of excessive or insufficient pressure, the syringe's low-friction plunger mechanism, and practical application. With this technique, the cuff is inflated through the pilot balloon valve using a loss-of-resistance syringe. Force on the plunger is then released, allowing it to move backward passively as air returns from the cuff. The syringe is disconnected when spontaneous plunger movement stops.\n\nThe clinical team independently decides whether and how to use a cuff inflation technique in routine clinical care. The research protocol does not assign patients to a technique. Researchers independent of the clinical team measure cuff pressure with a manometer after initial cuff inflation and before any corrective adjustment. The researcher measuring cuff pressure is unaware of the inflation technique until after the pressure has been measured and recorded. The initial value, rather than the value after safety correction, is used for the primary outcome. Pressures outside 20-30 cmH2O are corrected promptly for patient safety.\n\nCuff leakage and the need for additional air are recorded. Postoperative sore throat is assessed after extubation during postoperative recovery, once the patient is awake and able to answer questions. Demographic characteristics, surgical procedure, intubation attempts, tube characteristics and procedure durations are also recorded.\n\nThe primary analysis compares the proportion of patients with initial cuff pressure within 20-30 cmH2O between the pre-training and post-training cohorts, using the chi-square test or Fisher's exact test when appropriate. Cohorts are defined by observation period, not by the cuff inflation technique actually used. Continuous cuff pressure values will be compared using an independent-samples t test or the Mann-Whitney U test according to distribution. Secondary categorical outcomes will be compared using the chi-square test or Fisher's exact test. If appropriate, multivariable logistic regression will explore factors associated with postoperative sore throat. All tests will be two-sided with a significance level of 0.05.\n\nEstimated enrollment is 180 patients, with approximately equal numbers in each observation period. The protocol sample-size calculation is based on detecting a 25-percentage-point absolute difference in the primary proportion with 90% power and a two-sided alpha of 0.05. Final participant assessment is anticipated on November 30, 2026; analysis and reporting will take place afterward.","Consecutive adult surgical patients undergoing general anesthesia with endotracheal intubation at Kayseri City Hospital during the two-week observation period before anesthesia staff training and the two-week observation period after training. Participants must meet the inclusion and exclusion criteria. Only the first surgical procedure for each patient will be included.",[36,39],{"label":37,"type":29,"description":38,"interventionNames":29},"Pre-Training Cohort","Consecutive eligible adults undergoing general anesthesia with endotracheal intubation during the two-week period before staff training. Cuff inflation is selected and performed independently by the treating clinical team as part of routine care. An independent researcher records initial cuff pressure before corrective adjustment and learns the inflation technique only afterward. Cuff leakage, additional air requirement and postoperative sore throat are assessed.",{"label":40,"type":29,"description":41,"interventionNames":29},"Post-Training Cohort","Consecutive eligible adults undergoing general anesthesia with endotracheal intubation during the two-week period after staff training in the loss-of-resistance syringe technique. The treating clinical team independently chooses and performs the cuff inflation technique in routine care; no technique is assigned by researchers. An independent researcher records initial cuff pressure before corrective adjustment and learns the technique only afterward. Cuff leakage, additional air requirement and postoperative sore throat are assessed using the same procedures as in the pre-training cohort.",[43],{"name":44,"affiliation":5,"role":45},"Yusuf Yilmaz, MD","PRINCIPAL_INVESTIGATOR",[47],{"name":44,"role":48,"phone":49,"phoneExt":29,"email":50},"CONTACT","+90 555 538 30 94","doktoryusufyilmaz@gmail.com",[52],{"facility":5,"status":29,"city":53,"state":29,"zip":54,"country":55,"countryCode":29,"cosmosGeoPoint":56,"geoPoint":61,"contacts":29},"Kayseri","38080","Turkey (Türkiye)",{"type":57,"coordinates":58},"Point",[59,60],35.48528,38.73222,{"lat":60,"lon":59},{"type":63,"investigatorFullName":64,"investigatorTitle":65,"investigatorAffiliation":5,"oldNameTitle":29,"oldOrganization":29},"SPONSOR_INVESTIGATOR","Yusuf YILMAZ","Principal Investigator; Specialist in Anesthesiology and Reanimation","100657848","effect-of-loss-of-resistance-syringe-training-on-endotracheal-tube-cuff-pressure-100657848",false,"NCT07844486","Effect of Loss-of-Resistance Syringe Training on Endotracheal Tube Cuff Pressure","Effect of Training in the Loss-of-Resistance Syringe Technique on Optimizing Endotracheal Tube Cuff Pressure: A Prospective Before-and-After Study","Inclusion Criteria:\n\n* Age 18 years or older.\n* Undergoing general anesthesia with endotracheal intubation in the operating rooms of Kayseri City Hospital.\n* Able to communicate and undergo postoperative pain assessment.\n* Only the first surgical procedure for each patient is included.\n\nExclusion Criteria:\n\n* Neurological, psychiatric or cognitive impairment preventing communication.\n* Surgery that may independently affect postoperative sore throat, such as ear, nose and throat surgery or upper gastrointestinal surgery.\n* Three or more laryngoscopy attempts during intubation.\n* Nasotracheal intubation.\n* Use of a double-lumen endotracheal tube.\n* Intubation lasting longer than three hours.","ALL","18 Years",{"count":76,"type":77},180,"ESTIMATED","OBSERVATIONAL","This study will examine whether training the anesthesia team in a loss-of-resistance syringe technique is associated with improved breathing-tube cuff pressure in adults having surgery at Kayseri City Hospital. The cuff is an inflatable seal around the breathing tube. Pressure that is too high or too low may cause problems.\n\nApproximately 180 adults will be observed during a two-week period before staff training and a two-week period after training. The treating clinical team will independently choose how to inflate each cuff as part of routine care; researchers will not assign patients to a technique. A researcher independent of the treating team will measure cuff pressure and will learn which technique was used only after the measurement.\n\nThe main outcome is the percentage of patients whose first measured cuff pressure is within 20-30 cmH2O, compared between the periods before and after training. Pressures outside this range will be corrected for patient safety after the first measurement is recorded. Researchers will also record cuff leakage, the need for additional air, and sore throat after the breathing tube is removed, once the patient is awake and able to answer questions.",[81,82],"Endotracheal Tube Cuff Pressure","Postoperative Sore Throat",[84,85],"Loss-of-resistance syringe","Anesthesia education","NOT_YET_RECRUITING","2026-09-25",{"date":89,"type":90},"2026-09-28","ACTUAL",{"date":92,"type":77},"2026-10-01",{"date":94,"type":77},"2026-11-30",{"name":64,"class":6},1]