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

May 20, 2026 updated by: Fehmi Güralp Güray, Ankara Etlik City Hospital

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

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.

Study Overview

Status

Not yet recruiting

Conditions

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.

Study Type

Observational

Enrollment (Estimated)

76

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
This outcome assesses early postoperative lung aeration changes between baseline (LUS 0, at T0: pre-induction, awake, supine) and 30 minutes postoperatively in the post-anesthesia care unit (LUS 1). Aeration is evaluated via a 12-region ultrasound protocol (each quadrant scored 0-3; total 0-36). This acute change (LUS 0 to LUS 1) will be correlated with mean intraoperative driving pressure (ΔP = Pplat - PEEP). Mean ΔP is the average of measurements at specific milestones: T_basal (immediately post-intubation), T1 (1st hour, post-establishment of pneumoperitoneum and deep Trendelenburg), T2, T3, T4, T5 (hourly maintenance), and T_neutral (within 10 minutes post-desufflation, return to supine).
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).
This outcome investigates the correlation between total anesthesia/mechanical ventilation duration (measured in minutes from T0: pre-induction to extubation) and changes in lung aeration. The clinical impact of operative time on atelectasis will be evaluated by correlating this duration with early (LUS 0 at T0 to LUS 1 at postop 30 min) and persistent (LUS 0 to LUS 2 at postop 24 hours) LUS changes. The intraoperative timeline includes predefined milestones: T_basal (post-intubation), T1 (1st hour, post-pneumoperitoneum and deep Trendelenburg), T2, T3, T4, T5 (hourly maintenance), and T_neutral (post-desufflation, return to supine).
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.
This outcome evaluates cumulative energy delivered to the respiratory system (Mechanical Power, MP) during volume-controlled ventilation. Average (MP_mean) and maximum (MP_max) MP will be retrospectively calculated via the simplified Gattinoni formula using ventilator data at milestones: T_basal (immediately post-intubation), T1 (1st hour, post-pneumoperitoneum and deep Trendelenburg), T2, T3, T4, T5 (hourly maintenance), and T_neutral (post-desufflation). These intraoperative energy metrics will be correlated with early (LUS 0 to LUS 1 at 30 min) and persistent (LUS 0 to LUS 2 at 24 hours) postoperative changes in lung aeration.
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).
This outcome assesses immediate physiological impacts of driving pressure (ΔP) changes induced by pneumoperitoneum and deep Trendelenburg. Arterial blood gas (ABG) parameters, specifically pH, PaO2/FiO2 ratio (Horowitz index), PaCO2, and lactate, will be correlated with the ΔP (Pplat - PEEP) measured at exact corresponding milestones: T_basal (immediately post-intubation), T1 (1st hour, immediately post-establishment of pneumoperitoneum and deep Trendelenburg), T2, T3, T4, T5 (hourly maintenance), and T_neutral (within 10 minutes post-desufflation, return to supine).
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.
This outcome tracks postoperative pulmonary complications (PPCs) to evaluate the clinical impact of intraoperative ventilation. PPCs are defined as transient or persistent desaturation (SpO2 < 92%), clinical need for supplemental oxygen, or tachypnea in the PACU. This incidence is correlated with the mean intraoperative driving pressure (ΔP) calculated as the average across milestones: T_basal (post-intubation), T1 (1st hour, post-pneumoperitoneum and deep Trendelenburg), T2, T3, T4, T5 (hourly maintenance), and T_neutral (post-desufflation, return to supine). Clinical follow-up extends up to 24 hours.
From the end of surgery (extubation) up to 24 hours postoperatively.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ankara Etlik City Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 30, 2026

Primary Completion (Estimated)

August 20, 2026

Study Completion (Estimated)

September 15, 2026

Study Registration Dates

First Submitted

May 5, 2026

First Submitted That Met QC Criteria

May 20, 2026

First Posted (Actual)

May 28, 2026

Study Record Updates

Last Update Posted (Actual)

May 28, 2026

Last Update Submitted That Met QC Criteria

May 20, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • AEŞH-EK-2026-018

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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