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NCT07242144
Effect of Changes in Endotracheal Tube Cuff Pressure on Postoperative Pharyngolaryngeal Complications in Robotic Surgery
trial testing Continuous Monitoring of Endotracheal Tube Cuff Pressure in Robot-Assisted Radical Prostatectomy in 50 participants. Completed in 1 January 2025.
1 July 2024
Quick facts
| Lead sponsor | Ege University |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 50 |
| Start date | 1 August 2023 |
| Primary completion | 1 July 2024 |
| Estimated completion | 1 January 2025 |
| Sites | 1 location across Turkey (Türkiye) |
Drugs / interventions tested
- Continuous Monitoring of Endotracheal Tube Cuff Pressure
Conditions studied
- Robot-Assisted Radical Prostatectomy — all drugs for Robot-Assisted Radical Prostatectomy →
- Prostatic Neoplasms — all drugs for Prostatic Neoplasms →
Sponsor
Ege University
Who can join
Adults 40 to 80, male only, with Robot-Assisted Radical Prostatectomy or Prostatic Neoplasms. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07242144 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Ege University
- Last refreshed: 28 November 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07242144.
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