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

NCT07242144 | Completed

• 1 other identifier: EUTF 23-7/3
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Endotracheal tube cuff pressure; postoperative pharyngolaryngeal complications; Robot-Assisted Radical Prostatectomy; pneumoperitoneum; steep Trendelenburg position

Outcome Measures

Primary Outcomes (2)

• Incidence of Postoperative Pharyngolaryngeal Complications

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

  Within 24 hours postoperatively

• Change in Endotracheal Tube Cuff Pressure During Surgery

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

  Intraoperative period (from induction to end of surgery)]

Study Arms (2)

Robot-Assisted Radical Prostatectomy (RALP)

Patients undergoing robot-assisted laparoscopic radical prostatectomy under general anesthesia with a steep Trendelenburg position and pneumoperitoneum

Other: Continuous Monitoring of Endotracheal Tube Cuff Pressure

Open Radical Prostatectomy (ORP)

Patients undergoing open radical prostatectomy under general anesthesia without Trendelenburg position or pneumoperitoneum.

Other: Continuous Monitoring of Endotracheal Tube Cuff Pressure

Interventions

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).

Open Radical Prostatectomy (ORP); Robot-Assisted Radical Prostatectomy (RALP)

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population consists of male patients aged 40 to 80 years who underwent elective robot-assisted laparoscopic radical prostatectomy (RALP) or open radical prostatectomy under general anesthesia at Ege University Faculty of Medicine Hospital. All participants were classified as American Society of Anesthesiologists (ASA) physical status I-II and provided written informed consent prior to inclusion

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ege University: lead

Study Sites (1)

Ege University Medical Faculty Department of Anesthesiology and Reanimation

Izmir, Bornova, 35100, Turkey (Türkiye)

Location

Related Publications (4)

• Zhu G, Wang X, Cao X, Yang C, Wang B, Ang Y, Duan M. The effect of different endotracheal tube cuff pressure monitoring systems on postoperative sore throat in patients undergoing tracheal intubation: a randomized clinical trial. BMC Anesthesiol. 2024 Mar 25;24(1):115. doi: 10.1186/s12871-024-02499-5.

  PMID: 38528475 BACKGROUND

• Liu J, Zhang X, Gong W, Li S, Wang F, Fu S, Zhang M, Hang Y. Correlations between controlled endotracheal tube cuff pressure and postprocedural complications: a multicenter study. Anesth Analg. 2010 Nov;111(5):1133-7. doi: 10.1213/ANE.0b013e3181f2ecc7. Epub 2010 Aug 24.

  PMID: 20736432 BACKGROUND

• Phong SV, Koh LK. Anaesthesia for robotic-assisted radical prostatectomy: considerations for laparoscopy in the Trendelenburg position. Anaesth Intensive Care. 2007 Apr;35(2):281-5. doi: 10.1177/0310057X0703500221.

  PMID: 17444322 BACKGROUND

• Tsunoda N, Asai T, Okuda Y. Tracheal tube cuff pressure during anesthesia for robotic-assisted laparoscopic prostatectomy and the efficacy of an automatic cuff pressure controller (SmartCuff): observational studies of 1-sample paired data. J Anesth. 2023 Apr;37(2):234-241. doi: 10.1007/s00540-022-03151-7. Epub 2022 Dec 16.

  PMID: 36525125 BACKGROUND

MeSH Terms

Conditions

Prostatic Neoplasms; Pneumoperitoneum

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Peritoneal Diseases; Digestive System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: November 21, 2025
• Study Start: August 1, 2023
• Primary Completion: July 1, 2024
• Study Completion: January 1, 2025
• Last Updated: November 28, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)