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

NCT07610824 | Recruiting

• 1 other identifier: AEŞH-EK-2026-018
• Study Type: observational
• Target: 76
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Prostatic Neoplams; Mechanical Ventilation; Postoperative Pulmonary Complications (PPCs); Driving Pressure; Lung Ultrasonography Score

Keywords

driving pressure; lung ultrasonography score; postoperative pulmonary comlications

Outcome Measures

Primary Outcomes (1)

• Change in Lung Ultrasound Score (LUS) From Preoperative Baseline to 24 Hours Postoperatively

  The primary outcome is the difference in lung aeration between preoperative baseline (LUS 0, at T0: pre-induction, awake, supine) and 24 hours postoperatively (LUS 2). Lung aeration is evaluated via a 12-region ultrasound protocol; each quadrant is scored 0-3, yielding a total of 0-36 (higher scores indicate worse aeration). This change (LUS 0 to LUS 2) will be correlated with the mean intraoperative driving pressure (ΔP = Pplat - PEEP). Mean ΔP is calculated as the average of measurements obtained at predefined intraoperative milestones: T\_basal (immediately post-intubation), T1 (1st hour, immediately post-establishment of pneumoperitoneum and deep Trendelenburg), T2, T3, T4, T5 (hourly intervals during pneumoperitoneum/Trendelenburg maintenance), and T\_neutral (within 10 minutes post-desufflation, return to supine).

  Baseline LUS0 (T0: pre-induction) and 24 hours postoperatively (LUS 2).

Secondary Outcomes (5)

• Change in Lung Ultrasound Score (LUS) From Preoperative Baseline(LUS0) to 30 Minutes Postoperatively(LUS1)

  Baseline (T0: pre-induction) and 30 minutes postoperatively (LUS 1).

• Correlation Between Total Anesthesia Duration and Postoperative Changes in Lung Ultrasound Scores (LUS)

  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)

  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

  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

  From the end of surgery (extubation) up to 24 hours postoperatively.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult male patients scheduled for elective robot-assisted laparoscopic radical prostatectomy at Etlik City Hospital.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ankara Etlik City Hospital: lead

Study Sites (1)

Etlik City Hospital

Ankara, Ankara, 06170, Turkey (Türkiye)

RECRUITING

Related Publications (3)

• 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 RESULT

• 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 RESULT

• 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 RESULT

Central Study Contacts

Fehmi Güralp Güray, MD

CONTACT

+905058618969; guralpguray1995@gmail.com

Savas Altınsoy, MD, Prof.

CONTACT

+905332257104; savasaltinsoy@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 5, 2026
• First Posted: May 28, 2026
• Study Start: May 30, 2026
• Primary Completion (Estimated): August 20, 2026
• Study Completion (Estimated): September 15, 2026
• Last Updated: June 11, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)