NCT07242144Completed
Effect of Changes in Endotracheal Tube Cuff Pressure on Postoperative Pharyngolaryngeal Complications in Robotic Surgery
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
Source: ClinicalTrials.gov · Last updated 28 Nov 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 50 (actual)
- First submitted
- 17 Nov 2025
- Start date
- 1 Aug 2023
- Primary completion date
- 1 Jul 2024
- Lead sponsor
- Ege University
- Diseases
- Prostate cancer
- NCT number
- NCT07242144
What you commit to
- Study type: Observational
- Participants enrolled: 50
- From 1 Aug 2023 to the primary completion date, 1 Jul 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- • 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
Who the study is looking for
- 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
Age in the registry: 40 years to 80 years · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Ege University Medical Faculty Department of Anesthesiology and Reanimation Coordinator of this site? Confirm its status | Izmir | Turkey (Türkiye) | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.