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Completed
NCT07842081
Scheduled Endotracheal Tube Cuff Pressure Management and Postoperative Sore Throat
Conditions: Postoperative Sore Throat, Endotracheal Intubation
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 126
Sponsor: Hitit University
Location: Hitit University Erol Olçok Training and Research Hospital Çorum
Summary
This randomized controlled trial evaluated whether scheduled measurement and adjustment of endotracheal tube cuff pressure using a handheld manometer could reduce postoperative sore throat in adults undergoing elective surgery under general anesthesia with tracheal intubation.
Participants were randomly assigned in a 1:1 ratio to either manometer-guided cuff-pressure management or conventional cuff inflation based on pilot-balloon palpation. In the manometer-guided group, cuff pressure was maintained within a target range of 25-30 cmH₂O. In the conventional group, cuff inflation was managed according to the attending anesthesiologist's usual clinical assessment.
Cuff pressure was assessed at predefined time points during anesthesia. Postoperative sore throat was evaluated at 1, 6, and 24 hours after extubation. Other postoperative airway symptoms, including hoarseness, difficulty swallowing, cough, and postoperative nausea or vomiting, were also assessed.
The main objective was to determine whether scheduled manometer-guided cuff-pressure management reduced the occurrence of postoperative sore throat within the first 24 hours after surgery compared with conventional pilot-balloon palpation.
Eligibility Criteria
Inclusion Criteria:
* Adults aged 18 years or older.
* American Society of Anesthesiologists (ASA) physical status I-III.
* Scheduled for elective surgery under general anesthesia with planned endotracheal intubation.
* Provided written informed consent.
Exclusion Criteria:
* Active upper respiratory tract infection on the day of surgery.
* Anticipated difficult airway.
* Anatomical laryngotracheal abnormality.
* Previous surgery or radiotherapy involving the laryngotracheal region.
* Anticipated need for postoperative tracheal intubation lasting more than 24 hours.
Source: ClinicalTrials.gov (NCT07842081). StuddyBuddy aggregates publicly available trial information.