Clinical trial · Observational
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostatic Neoplasms | Prostate Neoplasm | ALIAS | 0.90 |
| Robot-Assisted Radical Prostatectomy | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Continuous Monitoring of Endotracheal Tube Cuff Pressure | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Robot-Assisted Radical Prostatectomy (RALP)
- description
- Patients undergoing robot-assisted laparoscopic radical prostatectomy under general anesthesia with a steep Trendelenburg position and pneumoperitoneum
- interventionNames
- Other: Continuous Monitoring of Endotracheal Tube Cuff Pressure
- label
- Open Radical Prostatectomy (ORP)
- description
- Patients undergoing open radical prostatectomy under general anesthesia without Trendelenburg position or pneumoperitoneum.
- interventionNames
- Other: Continuous Monitoring of Endotracheal Tube Cuff Pressure
Primary outcomes (2)
- measure
- Incidence of Postoperative Pharyngolaryngeal Complications
- timeFrame
- Within 24 hours postoperatively
- description
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 40 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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
References
Publications (4)
- BACKGROUNDZhu 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
- BACKGROUNDLiu 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
- BACKGROUNDPhong 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
- BACKGROUNDTsunoda 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