NCT07427173

The Impact of Endotracheal Cuff Pressure Assessment Using a Cuff Pressure Manometer Compared With the Traditional Palpation Method on Postoperative Outcomes

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 104 (estimated)
• Sponsor: University of Gaziantep · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

The aim of this prospective observational study is to evaluate the effect of endotracheal cuff pressure management on postoperative complications in patients undergoing surgery under general anesthesia. Specifically, patients whose endotracheal cuff pressure is maintained at an optimal level using a manometer will be compared with those whose cuff pressure is assessed using the conventional palpation method. The primary question the study aims to answer is whether maintaining endotracheal cuff pressure at an optimal level with a manometer reduces the incidence of postoperative airway-related complications compared with the classical palpation technique.

Detailed description

Endotracheal intubation is routinely performed in patients undergoing surgery under general anesthesia. Maintaining appropriate endotracheal tube cuff pressure is critical to ensure adequate ventilation, prevent aspiration, and minimize tracheal mucosal injury. Excessive cuff pressure may compromise tracheal mucosal perfusion and increase the risk of postoperative airway-related complications such as sore throat, hoarseness, cough, dysphagia, and laryngospasm. Conversely, insufficient cuff pressure may lead to air leakage and aspiration risk. In routine clinical practice, cuff pressure is frequently assessed using conventional subjective methods such as manual palpation of the pilot balloon. However, this technique does not provide an accurate measurement and may result in pressures outside the recommended safe range (20-30 cmH₂O). Direct measurement using a manometer allows objective monitoring and adjustment of cuff pressure within the optimal range, potentially reducing airway mucosal damage and postoperative laryngeal complications. This prospective observational study aims to compare two approaches to cuff pressure management in adult patients undergoing elective surgery under general anesthesia with endotracheal intubation: Patients whose cuff pressure is measured and maintained within the optimal range using a manometer Patients whose cuff pressure is assessed using conventional methods such as palpation The primary outcome is the incidence of postoperative airway-related complications within the first 24 hours after extubation. These include sore throat, hoarseness, cough, dysphagia, and laryngospasm. Secondary outcomes include the severity of postoperative sore throat assessed using a Visual Analog Scale (VAS), the incidence of individual airway symptoms, measured cuff pressure values, duration of intubation, length of stay in the post-anesthesia care unit (PACU), and overall postoperative recovery quality assessed using the Quality of Recovery-15 (QoR-15) questionnaire. Eligible patients will be prospectively followed during the intraoperative period and evaluated postoperatively at predefined time points (e.g., 1, 6, and 24 hours after extubation). Demographic data, perioperative variables, and airway-related outcomes will be recorded and analyzed to determine whether objective cuff pressure monitoring with a manometer is associated with improved postoperative airway outcomes compared with conventional subjective assessment methods. This study is expected to provide clinically relevant evidence regarding optimal endotracheal cuff pressure management and its impact on postoperative airway morbidity.

Conditions

• Postoperative Airway Complications

Timeline

• Start date: 2026-02-18
• Primary completion: 2026-08-01
• Completion: 2026-09-01
• First posted: 2026-02-23
• Last updated: 2026-02-24