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Effect of Changes in Endotracheal Tube Cuff Pressure on Postoperative Pharyngolaryngeal Complications in Robotic Surgery

NCT07242144 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 50

Last updated 2025-11-28

No results posted yet for this study

Summary

The goal of this observational study is to evaluate how changes in endotracheal tube (ETT) cuff pressure during robot-assisted radical prostatectomy (RARP) affect postoperative throat-related symptoms. The main question the study aims to answer is: Do pneumoperitoneum and the steep Trendelenburg position used in robotic prostate surgery increase ETT cuff pressure and lead to a higher incidence of postoperative pharyngolaryngeal complications such as sore throat, hoarseness, or dysphagia? This study includes 50 male patients undergoing elective radical prostatectomy under general anesthesia, with 25 patients in the open surgery group and 25 in the robotic-assisted group. The ETT cuff pressure is initially adjusted to the lowest level that prevents air leakage (20-35 cmH#O) and is continuously monitored throughout surgery. Measurements are recorded at specific intraoperative time points related to pneumoperitoneum and positioning. After surgery, patients are evaluated at 2 and 24 hours postoperatively for throat-related symptoms such as sore throat, hoarseness, dysphagia, and cough. The results are expected to clarify whether intraoperative factors unique to robotic surgery contribute to increased cuff pressure and postoperative discomfort, emphasizing the importance of continuous cuff pressure monitoring and timely adjustment for patient safety.

Conditions

  • Robot-Assisted Radical Prostatectomy
  • Prostatic Neoplasms

Interventions

OTHER

Continuous Monitoring of Endotracheal Tube Cuff Pressure

Continuous intraoperative measurement of endotracheal tube cuff pressure using a manometer at predefined intraoperative time points (after intubation, after pneumoperitoneum, after Trendelenburg positioning, and every 15 minutes thereafter).

Sponsors & Collaborators

  • Ege University

    lead OTHER

Eligibility

Min Age
40 Years
Max Age
80 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-08-01
Primary Completion
2024-07-01
Completion
2025-01-01

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07242144 on ClinicalTrials.gov