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Recruiting NCT07610824

Intraoperative Driving Pressure and Postoperative Lung Ultrasound Score in Robot-Assisted Radical Prostatectomy

— Observational Mechanical Ventilation Postoperative Pulmonary Complications (PPCs) Prostatic Neoplams Driving Pressure

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Mechanical Ventilation, Postoperative Pulmonary Complications (PPCs), Prostatic Neoplams, Driving Pressure. Basic parameters: 18 years — 80 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Evaluation of the Relationship Between Intraoperative Driving Pressure and Postoperative Lung Ultrasound Score in Patients Undergoing Robot-Assisted Laparoscopic Radical Prostatectomy

Overview

The primary objective of this study is to evaluate the relationship between intraoperative driving pressure and postoperative lung ultrasound scores in patients undergoing robot-assisted laparoscopic radical prostatectomy. During this specific surgery, factors such as pneumoperitoneum and patient positioning can significantly affect respiratory mechanics. Postoperative lung condition will be objectively assessed using the lung ultrasound score (LUS). The findings may provide valuable insights for optimizing intraoperative mechanical ventilation strategies.

Detailed description

The primary objective of this study is to evaluate the relationship between intraoperative driving pressure and postoperative lung ultrasound scores in patients undergoing robot-assisted laparoscopic radical prostatectomy. During this specific surgery, factors such as pneumoperitoneum and patient positioning can significantly affect respiratory mechanics. By monitoring mechanical ventilation parameters, specifically driving pressure, this study aims to investigate its potential correlation with postoperative lung aeration changes. Postoperative lung condition will be objectively assessed using the lung ultrasound score (LUS). The findings may provide valuable insights for optimizing intraoperative mechanical ventilation strategies.

Primary outcome measures

  • Change in Lung Ultrasound Score (LUS) From Preoperative Baseline to 24 Hours Postoperatively [Time frame: Baseline LUS0 (T0: pre-induction) and 24 hours postoperatively (LUS 2).]
Secondary outcome measures (5)
  • Change in Lung Ultrasound Score (LUS) From Preoperative Baseline(LUS0) to 30 Minutes Postoperatively(LUS1) [Time frame: Baseline (T0: pre-induction) and 30 minutes postoperatively (LUS 1).]
  • Correlation Between Total Anesthesia Duration and Postoperative Changes in Lung Ultrasound Scores (LUS) [Time frame: From the start of anesthesia induction until extubation (for total duration, assessed up to 6 hours) and at specific assessment points: Baseline (T0), 30 minutes postoperatively (LUS 1), and 24 hours postoperatively (LUS 2).]
  • Correlation of Intraoperative Mechanical Power With Changes in Lung Ultrasound Scores (LUS) [Time frame: Intraoperatively from anesthesia induction to the end of surgery (for mechanical power data collection, assessed up to 6 hours) and at Baseline (T0), 30 minutes (LUS 1), and 24 hours postoperatively (LUS 2) for ultrasound scores.]
  • Correlation Between Intraoperative Driving Pressure and Arterial Blood Gas Parameters [Time frame: Intraoperatively, at specific predefined milestones: T_basal, T1 (1st hour, immediately post-pneumoperitoneum/Trendelenburg), T2, T3, T4, T5, and T_neutral (assessed up to 6 hours).]
  • Incidence of Postoperative Pulmonary Complications (PPCs) and Correlation With Intraoperative Driving Pressure [Time frame: From the end of surgery (extubation) up to 24 hours postoperatively.]

Eligibility criteria

Inclusion criteria

  • Male patients aged between 18 and 80 years.

Scheduled for elective robot-assisted laparoscopic radical prostatectomy.

American Society of Anesthesiologists (ASA) physical status I, II, or III.

Willingness to provide written informed consent.

Exclusion criteria

  • Patient refusal to participate.

Severe obstructive or restrictive pulmonary disease (e.g., severe COPD, uncontrolled asthma).

Body Mass Index (BMI) > 35 kg/m\^2.

Pre-existing severe lung pathology or active pulmonary infection.

Hemodynamic instability or severe cardiovascular disease (e.g., severe heart failure, recent myocardial infarction).

Requirement for postoperative mechanical ventilation.

Emergency surgery.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Turkey (Türkiye) · 1 center
  • Etlik City Hospital — Ankara

Publications

  • Yoon HK, Kim BR, Yoon S, Jeong YH, Ku JH, Kim WH. The Effect of Ventilation with Individualized Positive End-Expiratory Pressure on Postoperative Atelectasis in Patients Undergoing Robot-Assisted Radical Prostatectomy: A Randomized Controlled Trial. J Clin Med. 2021 Feb 19;10(4):850. doi: 10.3390/jcm10040850. PMID 33669526
  • Li Y, Xu W, Cui Y, Sun Y, Wang C, Wen Z, An K. Effects of driving pressure-guided ventilation by individualized positive end-expiratory pressure on oxygenation undergoing robot-assisted laparoscopic radical prostatectomy: a randomized controlled clinical trial. J Anesth. 2023 Dec;37(6):896-904. doi: 10.1007/s00540-023-03251-y. Epub 2023 Sep 14. PMID 37707572
  • Zhang Y, Zhu J, Xi C, Wang G. Effect of driving pressure-guided individualized positive end-expiratory pressure (PEEP) ventilation strategy on postoperative atelectasis in patients undergoing laparoscopic surgery as assessed by ultrasonography: study protocol for a prospective randomized controlled trial. Trials. 2025 Mar 26;26(1):106. doi: 10.1186/s13063-025-08819-5. PMID 40140868

Identifiers

NCT: NCT07610824 · AEŞH-EK-2026-018

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗