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

November 21, 2025 updated by: Nursen Karaca, Ege University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
    • Bornova
      • Izmir, Bornova, Turkey (Türkiye), 35100
        • Ege University Medical Faculty Department of Anesthesiology and Reanimation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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)
Patients undergoing open radical prostatectomy under general anesthesia without Trendelenburg position or pneumoperitoneum.
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Postoperative Pharyngolaryngeal Complications
Time Frame: Within 24 hours postoperatively
Presence of cough assessed at 2 and 24 hours after extubation.
Within 24 hours postoperatively
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
Intraoperative period (from induction to end of surgery)]

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ege University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2023

Primary Completion (Actual)

July 1, 2024

Study Completion (Actual)

January 1, 2025

Study Registration Dates

First Submitted

November 17, 2025

First Submitted That Met QC Criteria

November 17, 2025

First Posted (Estimated)

November 21, 2025

Study Record Updates

Last Update Posted (Actual)

November 28, 2025

Last Update Submitted That Met QC Criteria

November 21, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EUTF 23-7/3

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data (IPD) will not be shared because this is a single center observational study with a small patient population and institutional confidentiality restrictions.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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