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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07610824
Enrollment
76
Registered
2026-05-28
Start date
2026-05-30
Completion date
2026-09-15
Last updated
2026-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

driving pressure, lung ultrasonography score, postoperative pulmonary comlications

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.

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.

Interventions

None listed

Sponsors

Ankara Etlik City Hospital
Lead SponsorOTHER_GOV

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
MALE
Age
18 Years to 80 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Change in Lung Ultrasound Score (LUS) From Preoperative Baseline to 24 Hours PostoperativelyBaseline 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).

Secondary

MeasureTime frameDescription
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).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).
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).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).
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.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.
Correlation Between Intraoperative Driving Pressure and Arterial Blood Gas ParametersIntraoperatively, 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).
Incidence of Postoperative Pulmonary Complications (PPCs) and Correlation With Intraoperative Driving PressureFrom 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.

Countries

Turkey (Türkiye)

Contacts

CONTACTFehmi Güralp Güray, MD
guralpguray1995@gmail.com+905058618969
CONTACTSavas Altınsoy, MD, Prof.
savasaltinsoy@gmail.com+905332257104

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 12, 2026