[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658380":3},{"organization":4,"outcomesModule":7,"designInfo":39,"detailedDescription":42,"studyPopulation":43,"armGroups":44,"interventions":50,"overallOfficials":38,"centralContacts":56,"locations":62,"responsibleParty":79,"collaborators":38,"id":83,"slug":84,"hasResults":85,"nctId":86,"briefTitle":87,"officialTitle":88,"acronym":38,"eligibilityCriteria":89,"healthyVolunteers":85,"sex":90,"minAge":91,"maxAge":92,"enrollmentInfo":93,"targetDuration":38,"studyType":96,"phases":38,"briefSummary":97,"conditions":98,"keywords":102,"overallStatus":112,"whyStopped":38,"lastUpdateSubmitDate":113,"lastUpdatePostDateStruct":114,"startDateStruct":117,"completionDateStruct":119,"leadSponsor":121,"locationsCount":122},{"fullName":5,"class":6},"Fatih Sultan Mehmet Training and Research Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":38},[9],{"measure":10,"description":11,"timeFrame":12},"Maximum Increase in Endotracheal Tube Cuff Pressure (ΔPmax)","After the participant is placed in the beach-chair position, endotracheal tube cuff pressure will be adjusted to a standardized baseline of 25 cmH2O. Cuff pressure will then be measured immediately before readjustment at 15, 30, 45, and 60 minutes after the start of irrigation, every 30 minutes thereafter, and at the end of surgery. ΔPmax, expressed in cmH2O, will be calculated as the highest cuff pressure recorded during surgery minus the standardized baseline pressure of 25 cmH2O. Higher values indicate a greater increase in cuff pressure. The association between ΔPmax and total irrigation fluid volume, recorded in liters, will be evaluated.","From 5 minutes after beach-chair positioning until completion of surgery, approximately 1 to 3 hours",[14,17,20,24,27,31,35],{"measure":15,"description":16,"timeFrame":12},"Maximum Endotracheal Tube Cuff Pressure","The highest endotracheal tube cuff pressure recorded in each participant at any prespecified intraoperative measurement time point before the pressure is readjusted to 25 cmH2O. The outcome will be reported in cmH2O. Higher values indicate greater maximum cuff pressure.",{"measure":18,"description":19,"timeFrame":12},"Occurrence of Endotracheal Tube Cuff Pressure Above 30 cmH2O","The occurrence of at least one endotracheal tube cuff pressure measurement greater than 30 cmH2O before pressure readjustment at any prespecified intraoperative time point. The outcome will be reported as the number and percentage of participants with at least one measurement above 30 cmH2O.",{"measure":21,"description":22,"timeFrame":23},"Change in Anterior Neck Soft Tissue Thickness","Anterior neck soft tissue thickness will be measured by ultrasonography at the level of the cricoid cartilage, from the skin to the anterior tracheal air-mucosa interface. Three measurements will be obtained before anesthesia and after surgery before extubation, and the average will be calculated for each assessment. Change will be calculated as the postoperative average minus the preoperative average and reported in millimeters. Positive values indicate increased tissue thickness. Its association with total irrigation fluid volume will also be evaluated.","From the preoperative assessment before anesthesia induction to the postoperative assessment before extubation, approximately 1 to 3 hours",{"measure":25,"description":26,"timeFrame":23},"Change in Neck Circumference","Neck circumference will be measured with a non-stretchable measuring tape at the marked cricoid cartilage level before anesthesia and after surgery before extubation. Change will be calculated as the postoperative measurement minus the preoperative measurement and reported in centimeters. Positive values indicate an increase in neck circumference.",{"measure":28,"description":29,"timeFrame":30},"Association Between Surgical Duration and Maximum Cuff Pressure Increase","Surgical duration will be recorded in minutes, and the maximum increase in endotracheal tube cuff pressure will be calculated as the highest intraoperative cuff pressure minus the standardized baseline of 25 cmH2O. The association between surgical duration and maximum cuff pressure increase will be evaluated using a Pearson or Spearman correlation coefficient, depending on data distribution.","During surgery, approximately 1 to 3 hours",{"measure":32,"description":33,"timeFrame":34},"Postoperative Sore Throat Intensity","Sore throat intensity will be assessed using an 11-point numerical rating scale ranging from 0 to 10, where 0 indicates no sore throat and 10 indicates the worst possible sore throat. Assessments will be performed at admission to the post-anesthesia care unit and at the postoperative sixth hour. The association between sore throat scores and maximum cuff pressure increase will also be evaluated.","At post-anesthesia care unit admission and 6 hours after surgery",{"measure":36,"description":37,"timeFrame":34},"Postoperative Hoarseness Severity","Hoarseness will be assessed and categorized as absent, mild, moderate, or severe at admission to the post-anesthesia care unit and at the postoperative sixth hour. The number and percentage of participants in each category will be reported. The association between hoarseness severity and maximum cuff pressure increase will also be evaluated.",null,{"allocation":38,"interventionModel":38,"interventionModelDescription":38,"primaryPurpose":38,"observationalModel":40,"timePerspective":41,"maskingInfo":38},"COHORT","PROSPECTIVE","Shoulder arthroscopy requires pressurized irrigation to expand the glenohumeral joint and subacromial space and maintain adequate surgical visualization. A portion of the irrigation fluid may pass into the periarticular tissues and extend along anatomical planes toward the shoulder girdle, supraclavicular region, chest wall, and neck. This fluid movement may cause cervical soft tissue edema and potentially affect endotracheal tube cuff pressure. However, prospective data combining standardized serial cuff pressure measurements with ultrasonographic assessment of anterior neck soft tissue thickness are limited.\n\nThis single-center, prospective observational cohort study will include approximately 60 adults undergoing elective shoulder arthroscopy in the beach-chair position under general anesthesia with orotracheal intubation. Participation in the study will not alter the surgical indication, anesthesia management, irrigation pump settings, or other clinical treatment. All clinical decisions will remain at the discretion of the responsible anesthesia and surgical teams.\n\nAfter tracheal intubation, endotracheal tube cuff pressure will be measured with a calibrated manometer and adjusted to 25 cmH2O. Following placement in the beach-chair position, cuff pressure will be measured again after five minutes and readjusted to 25 cmH2O, which will serve as the standardized baseline. During surgery, cuff pressure will be recorded at 15, 30, 45, and 60 minutes after the start of irrigation and every 30 minutes thereafter while surgery continues. A final measurement will be obtained at the end of surgery while the participant remains in the beach-chair position. After each measurement, cuff pressure will be readjusted to 25 cmH2O to avoid prolonged exposure to elevated pressure. An additional measurement will be obtained five minutes after the participant is returned to the supine position.\n\nThe total volume of irrigation fluid, irrigation pump pressure, surgical duration, anesthesia duration, surgical procedure, intravenous crystalloid volume, estimated blood loss, and relevant airway and anesthesia variables will be recorded. The maximum increase in cuff pressure will be calculated as the highest measured intraoperative cuff pressure minus the standardized baseline pressure of 25 cmH2O.\n\nAnterior neck soft tissue thickness will be measured before anesthesia and again before extubation with a high-frequency linear ultrasound probe. Measurements will be obtained at the level of the cricoid cartilage, from the skin to the anterior tracheal air-mucosa interface. Three measurements will be taken at each assessment, and their average will be used. Neck circumference will be measured at the same anatomical level before and after surgery.\n\nPostoperative sore throat will be assessed using a 0-to-10 numerical rating scale, and hoarseness will be graded as absent, mild, moderate, or severe. Dysphagia, stridor, delayed extubation, and other airway-related events will also be recorded in the post-anesthesia care unit and at the postoperative sixth hour.","The study population will consist of adult patients scheduled for elective shoulder arthroscopy in the beach-chair position under general anesthesia with orotracheal intubation at Fatih Sultan Mehmet Training and Research Hospital. Consecutive patients will be screened preoperatively, and eligible patients who provide written informed consent will be enrolled. Participants of all biological sexes with American Society of Anesthesiologists physical status I-III will be included. The study is observational and will not alter routine surgical or anesthesia management.",[45],{"label":46,"type":38,"description":47,"interventionNames":48},"Shoulder Arthroscopy Cohort","Adults aged 18 to 75 years with ASA physical status I-III who are undergoing elective shoulder arthroscopy in the beach-chair position under general anesthesia with orotracheal intubation. No intervention will be assigned by the study, and routine anesthesia, surgical management, and irrigation pump settings will not be changed. Total irrigation fluid volume, serial endotracheal tube cuff pressures, preoperative and postoperative anterior neck soft tissue thickness and neck circumference, and postoperative airway symptoms will be recorded.",[49],"Procedure: Elective Shoulder Arthroscopy",[51],{"type":52,"name":53,"description":54,"armGroupLabels":55,"otherNames":38},"PROCEDURE","Elective Shoulder Arthroscopy","Participants will undergo elective shoulder arthroscopy in the beach-chair position under general anesthesia with orotracheal intubation as part of routine clinical care. The study will not assign or modify the surgical indication, arthroscopic procedure, patient positioning, irrigation fluid, irrigation pump settings, or anesthesia management. Researchers will observe and record the total irrigation fluid volume and will perform serial endotracheal tube cuff pressure measurements and preoperative and postoperative assessments of anterior neck soft tissue thickness and neck circumference.",[46],[57],{"name":58,"role":59,"phone":60,"phoneExt":38,"email":61},"Doğa Meriç Yükselen, MD","CONTACT","+905362963155","d.m.boybeyi@gmail.com",[63],{"facility":64,"status":38,"city":65,"state":38,"zip":66,"country":67,"countryCode":38,"cosmosGeoPoint":68,"geoPoint":73,"contacts":74},"University of Health Sciences Fatih Sultan Mehmet Training and Research Hospital Scientific Research","Istanbul","34000","Turkey (Türkiye)",{"type":69,"coordinates":70},"Point",[71,72],28.94966,41.01384,{"lat":72,"lon":71},[75],{"name":76,"role":59,"phone":77,"phoneExt":38,"email":78},"Cansu Ofluoglu, MD","+905358640564","cansuakin.iu@gmail.com",{"type":80,"investigatorFullName":81,"investigatorTitle":82,"investigatorAffiliation":5,"oldNameTitle":38,"oldOrganization":38},"PRINCIPAL_INVESTIGATOR","Doğa Meriç Yükselen","Anesthesiology and Reanimation Specialist","100658380","irrigation-fluid-volume-tube-cuff-pressure-and-neck-swelling-during-shoulder-arthroscopy-100658380",false,"NCT07852702","Irrigation Fluid Volume, Tube Cuff Pressure, and Neck Swelling During Shoulder Arthroscopy","Relationship Between Irrigation Fluid Volume, Endotracheal Tube Cuff Pressure, and Anterior Neck Soft Tissue Thickness in Shoulder Arthroscopy: A Prospective Observational Study","Inclusion Criteria:\n\n* Age 18 to 75 years\n* American Society of Anesthesiologists physical status I-III\n* Scheduled for elective shoulder arthroscopy in the beach-chair position under general anesthesia with orotracheal intubation\n* Able to read and understand Turkish and provide written informed consent\n\nExclusion Criteria:\n\n* Emergency surgery\n* Pregnancy\n* Preoperative hoarseness, sore throat, or dysphagia\n* Upper respiratory tract infection within the previous 2 weeks\n* Tracheostomy, known laryngeal or tracheal disease, or previous major neck surgery or radiotherapy\n* Anticipated difficult airway, defined as Mallampati class III-IV or difficult airway predicted by the attending anesthesiologist\n* More than two tracheal intubation attempts or traumatic intubation\n* Surgery performed in the lateral decubitus position\n* Intraoperative use of nitrous oxide\n* Inability to obtain reliable ultrasonographic measurements","ALL","18 Years","75 Years",{"count":94,"type":95},60,"ESTIMATED","OBSERVATIONAL","During shoulder arthroscopy, fluid is pumped into the shoulder to help the surgeon see inside the joint. Some of this fluid can move into the tissues around the shoulder and neck and cause swelling. During general anesthesia, a breathing tube is placed in the windpipe. This tube has a small inflatable balloon, called a cuff, whose pressure may increase when the surrounding tissues swell.\n\nThe purpose of this study is to determine whether larger amounts of irrigation fluid used during shoulder arthroscopy are associated with greater increases in breathing tube cuff pressure and neck soft tissue thickness.\n\nAbout 60 adults undergoing planned shoulder arthroscopy in the beach-chair position will take part. The study will not change the participants' anesthesia, surgery, or treatment. Researchers will record the amount of irrigation fluid used, measure cuff pressure at set times during surgery, and measure the neck before and after surgery using ultrasound and a measuring tape. Sore throat, hoarseness, and other airway symptoms will be assessed after surgery. Participants will be followed until six hours after surgery.",[99,100,101],"Shoulder Arthroscopy","Endotracheal Tube Cuff Pressure","Neck Soft Tissue Edema",[103,104,105,106,107,108,109,110,111],"irrigation fluid volume","fluid extravasation","endotracheal tube cuff pressure","anterior neck soft tissue thickness","neck ultrasonography","beach-chair position","cervical soft tissue edema","postoperative sore throat","hoarseness","NOT_YET_RECRUITING","2026-09-25",{"date":115,"type":116},"2026-10-01","ACTUAL",{"date":118,"type":95},"2026-10-15",{"date":120,"type":95},"2027-03-15",{"name":5,"class":6},1]