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Completed

NCT Number: NCT07242144

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

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.

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Key information

Age range

40 year–80 year

Sex eligibility

Male

Study type

Observational

Primary location

Ege University Medical Faculty Department of Anesthesiology and Reanimation

Izmir, Bornova, 35100, Turkey (Türkiye)

About this study

Endotracheal tube (ETT) cuff pressure management is critical in maintaining airway safety during general anesthesia. Excessive cuff pressure may cause mucosal ischemia and postoperative complications such as sore throat, hoarseness, and dysphagia, while insufficient pressure can lead to air leakage and aspiration risk. During robot-assisted laparoscopic radical prostatectomy (RARP), patients are placed in a steep Trendelenburg position with pneumoperitoneum, which may significantly affect airway mechanics and ETT cuff pressure due to increased intrathoracic and airway pressures. This observational study aims to investigate how intraoperative factors unique to robotic surgery-particularly pneumoperitoneum and Trendelenburg positioning-affect ETT cuff pressure and postoperative pharyngolaryngeal outcomes. Fifty adult male patients scheduled for elective radical prostatectomy under general anesthesia are included. Twenty-five undergo open surgery, and twenty-five undergo robotic-assisted surgery. After intubation, the ETT cuff is inflated to the minimal occlusive volume (20-35 cmH#O) and monitored continuously throughout the procedure. Cuff pressure measurements are obtained at defined intraoperative time points, including after pneumoperitoneum, following positioning, and periodically during surgery. Postoperative evaluation includes structured interviews at 2 and 24 hours after extubation to document throat-related symptoms such as sore throat, hoarseness, dysphagia, and cough. The study seeks to provide practical evidence on whether robotic surgical positioning and pneumoperitoneum contribute to elevated cuff pressure and subsequent airway discomfort. These findings may highlight the need for continuous cuff pressure monitoring and adjustment during robot-assisted procedures to improve patient safety and postoperative comfort.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male patients aged 40 to 80 years
  • Classified as American Society of Anesthesiologists (ASA) physical status I-II
  • Scheduled for elective robot-assisted laparoscopic radical prostatectomy (RALP) or open radical prostatectomy under general anesthesia
  • Able to understand the study procedure and provide written informed consent

Exclusion criteria

  • • Emergency surgery
  • Upper or lower respiratory tract infection within 10 days before surgery
  • ASA physical status > III
  • Obstructed or kinked intraoperative endotracheal tube
  • Risk of aspiration (e.g., gastroesophageal reflux, full stomach)
  • Preoperative sore throat or existing pharyngolaryngeal symptoms
  • Body mass index (BMI) > 35 kg/m²

Treatment and study plan

Continuous Monitoring of Endotracheal Tube Cuff Pressure

Other

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).

Primary outcomes

  1. Incidence of Postoperative Pharyngolaryngeal Complications

    Time frame: Within 24 hours postoperatively

    Presence of cough assessed at 2 and 24 hours after extubation.

  2. Change in Endotracheal Tube Cuff Pressure During Surgery

    Time frame: Intraoperative period (from induction to end of surgery)]

    Endotracheal tube cuff pressure will be continuously monitored from intubation (T1) through various intraoperative stages, including pneumoperitoneum, Trendelenburg positioning, and desufflation

Sponsors and collaborators

Lead sponsor

Ege University

Other

Registry information

Official study title

A Prospective Observational Study on the Effect of Changes in Endotracheal Tube Cuff Pressure on Postoperative Pharyngolaryngeal Complications in Patients Undergoing Robot-Assisted Radical Prostatectomy

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Nov 21, 2025
Registry last updated
Nov 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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