[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100619209":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":46,"centralContacts":51,"locations":61,"responsibleParty":82,"collaborators":55,"id":85,"slug":86,"hasResults":87,"nctId":88,"briefTitle":89,"officialTitle":90,"acronym":55,"eligibilityCriteria":91,"healthyVolunteers":87,"sex":92,"minAge":93,"maxAge":94,"enrollmentInfo":95,"targetDuration":55,"studyType":98,"phases":99,"briefSummary":101,"conditions":102,"keywords":108,"overallStatus":113,"whyStopped":55,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":115,"startDateStruct":118,"completionDateStruct":120,"leadSponsor":122,"locationsCount":123},{"fullName":5,"class":6},"Izmir Katip Celebi University","OTHER",[8,14,20],{"label":9,"type":10,"description":11,"interventionNames":12},"Continuous Pressure Indicator Group","EXPERIMENTAL","Patients in this group will have their endotracheal tube cuff pressure continuously monitored and maintained within the range of 20-30 cmH₂O using a continuous pressure indicator device throughout the surgery.",[13],"Device: Continuous Cuff Pressure Indicator",{"label":15,"type":16,"description":17,"interventionNames":18},"Manometer Group","ACTIVE_COMPARATOR","Patients in this group will have their endotracheal tube cuff pressure measured and adjusted once using a manual manometer immediately after intubation to a target range of 20-30 cmH₂O.",[19],"Device: Manual Cuff Pressure Manometer",{"label":21,"type":16,"description":22,"interventionNames":23},"Control Group (Minimal Occlusive Volume)","Patients in this group will have their endotracheal tube cuff inflated using the minimal occlusive volume technique (inflating until the air leak stops) without the use of a pressure gauge.",[24],"Procedure: Minimal Occlusive Volume Technique",[26,33,39],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"DEVICE","Continuous Cuff Pressure Indicator","A device utilized to continuously monitor the endotracheal tube cuff pressure intraoperatively. It allows for real-time observation and maintenance of the pressure within the target range of 20-30 cmH₂O throughout the surgery.",[9],[32],"Continuous Cuff Pressure Controller",{"type":27,"name":34,"description":35,"armGroupLabels":36,"otherNames":37},"Manual Cuff Pressure Manometer","A standard analog manometer used for a single-time measurement of the endotracheal tube cuff pressure immediately after intubation. The pressure is adjusted to the standard range of 20-30 cmH₂O and not monitored continuously thereafter.",[15],[38],"Handheld Cuff Manometer",{"type":40,"name":41,"description":42,"armGroupLabels":43,"otherNames":44},"PROCEDURE","Minimal Occlusive Volume Technique","A standard clinical technique where the endotracheal tube cuff is inflated with the minimum volume of air required to prevent audible air leakage during positive pressure ventilation. No objective pressure gauge is used for adjustment.",[21],[45],"Leak Test Method",[47],{"name":48,"affiliation":49,"role":50},"Murat Aksun, M.D.","Izmir Katip Celebi University Atatürk Training and Research Hospital","PRINCIPAL_INVESTIGATOR",[52,57],{"name":48,"role":53,"phone":54,"phoneExt":55,"email":56},"CONTACT","+90 552 363 16 14",null,"murataksun@yahoo.com",{"name":58,"role":53,"phone":59,"phoneExt":55,"email":60},"Ahmet Salih Tüzen, M.D.","+90 535 391 55 77","astuzen@icloud.com",[62],{"facility":49,"status":55,"city":63,"state":64,"zip":65,"country":66,"countryCode":55,"cosmosGeoPoint":67,"geoPoint":72,"contacts":73},"Izmir","Karabaglar","35360","Turkey (Türkiye)",{"type":68,"coordinates":69},"Point",[70,71],27.13838,38.41273,{"lat":71,"lon":70},[74,78,79],{"name":75,"role":53,"phone":76,"phoneExt":55,"email":77},"Pınar Durak, M.D.","+90 535 399 59 52","pinaardurak@icloud.com",{"name":58,"role":53,"phone":59,"phoneExt":55,"email":60},{"name":80,"role":81,"phone":55,"phoneExt":55,"email":55},"Senem Girgin, M.D.","SUB_INVESTIGATOR",{"type":50,"investigatorFullName":83,"investigatorTitle":84,"investigatorAffiliation":5,"oldNameTitle":55,"oldOrganization":55},"Ahmet Salih Tüzen, MD","Medical Doctor","100619209","effect-of-cuff-pressure-assessment-methods-on-postoperative-complications-in-breast-surgery-100619209",false,"NCT07341646","Effect of Cuff Pressure Assessment Methods on Postoperative Complications in Breast Surgery","The Effect of Endotracheal Tube Cuff Pressure Assessment Methods on Postoperative Complications in Patients Undergoing Elective Breast Surgery: A Randomized Controlled Trial","Inclusion Criteria:\n\n* Female patients aged 18 to 65 years.\n* Patients classified as American Society of Anesthesiologists (ASA) physical status I, II, or III.\n* Patients scheduled for elective breast surgery requiring general anesthesia and endotracheal intubation.\n* Patients who provide voluntary written informed consent to participate.\n\nExclusion Criteria:\n\n* Patients with a history of Chronic Obstructive Pulmonary Disease (COPD) or an asthma attack within the last 6 months.\n* Presence of preoperative sore throat, hoarseness, or cough.\n* Patients with predicted difficult intubation or those who are difficult to intubate.\n* Patients with communication difficulties that prevent accurate assessment of symptoms.\n* Patients whose surgery duration exceeds 3 hours.\n* Patients older than 65 years.","FEMALE","18 Years","65 Years",{"count":96,"type":97},90,"ESTIMATED","INTERVENTIONAL",[100],"NA","Endotracheal intubation is a standard procedure used to secure the airway during general anesthesia. A key component of the breathing tube is the \"cuff,\" a balloon-like device that is inflated to seal the airway and prevent aspiration. However, if the pressure within this cuff is too high, it can restrict blood flow to the tracheal lining, leading to complications such as postoperative sore throat, hoarseness, and difficulty swallowing (dysphagia).\n\nCurrently, there are various methods to monitor and adjust this pressure. In many clinical practices, the pressure is adjusted subjectively or checked only once at the beginning of the surgery. These methods may allow pressure to exceed safe limits (typically 20-30 cmH₂O) or fluctuate during the procedure, potentially causing tissue irritation. This randomized controlled trial aims to compare three different methods of assessing and maintaining endotracheal tube cuff pressure to determine which is most effective at reducing postoperative complications. The study focuses on women undergoing elective breast surgery, a group chosen because the surgery typically lasts 1-3 hours and does not involve major changes in head and neck position, allowing for a clear assessment of the cuff pressure methods.\n\nParticipants will be randomly assigned to one of three groups:\n\n* Continuous Monitoring Group: Cuff pressure is monitored continuously using a pressure indicator and maintained within the 20-30 cmH₂O range throughout the surgery.\n* Manometer Group: Cuff pressure is measured and set to 20-30 cmH₂O using a manual manometer once, immediately after intubation.\n* Control Group (Minimal Occlusive Volume): The cuff is inflated with the minimum amount of air required to prevent an air leak, without using a pressure gauge.\n\nResearchers will assess patients for sore throat, cough, hoarseness, and swallowing difficulties at 0, 1, 12, and 24 hours after surgery to identify the safest and most comfortable method for airway management.",[103,104,105,106,107],"Airway Complications","Postoperative Sore Throat","Hoarseness","Dysphagia","Cough Severity",[109,110,111,104,103,112],"Continuous Cuff Pressure Monitoring","Manometer","Endotracheal Tube Cuff Pressure","Intubation Safety","NOT_YET_RECRUITING","2026-01-14",{"date":116,"type":117},"2026-01-15","ACTUAL",{"date":119,"type":97},"2026-03-01",{"date":121,"type":97},"2027-06-01",{"name":5,"class":6},1]