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Cerebral Hemodynamic Effects of Individualized PEEP During Robotic Prostatectomy

2026年8月23日 更新者:Ezgi Budak Ozyalcın、Istanbul University

Comparison of the Effects of Individualized PEEP Titration Versus Standard PEEP on Transcranial Doppler-Measured Cerebral Hemodynamic Parameters and Postoperative Neurocognitive Functions in Patients Undergoing Robotic Prostatectomy in the Trendelenburg Position

This randomized clinical trial will compare two approaches to setting positive end-expiratory pressure (PEEP) during robot-assisted radical prostatectomy performed in the Trendelenburg position. The study aims to determine whether individualized PEEP, selected according to the lowest driving pressure, affects cerebral blood flow and brain oxygenation differently from standard PEEP.

Approximately 45 adult patients undergoing robot-assisted radical prostatectomy will be randomly assigned to receive either individualized PEEP or standard PEEP during general anesthesia. Cerebral blood flow will be assessed noninvasively using transcranial Doppler ultrasound, and brain oxygenation will be monitored using near-infrared spectroscopy. Participants will also undergo brief assessments of attention, cognitive function, delirium, and sedation before and after surgery, with follow-up continuing for up to 48 hours after the operation.

Both ventilation approaches are routinely used in clinical practice, and no experimental drug, device, or additional invasive procedure will be used as part of the study.

研究概览

详细说明

This single-center, prospective, randomized, parallel-group clinical trial will evaluate the effects of individualized positive end-expiratory pressure (PEEP) titration compared with standard fixed PEEP on cerebral hemodynamics during robot-assisted laparoscopic radical prostatectomy performed in steep Trendelenburg position with pneumoperitoneum.

Approximately 45 adult patients aged 18-80 years with American Society of Anesthesiologists (ASA) physical status I-III who are scheduled for robot-assisted laparoscopic radical prostatectomy will be randomized in a 1:1 ratio to either an individualized PEEP group or a standard PEEP group. All patients will receive standardized general anesthesia and volume-controlled ventilation. Ventilation will initially be set with a tidal volume of 8 mL/kg predicted body weight, an inspiratory-to-expiratory ratio of 1:2, and an inspired oxygen fraction of 0.40, with end-tidal carbon dioxide maintained at 35-40 mmHg.

In the standard PEEP group, PEEP will be maintained at 6 cmH2O following a recruitment maneuver. In the individualized PEEP group, a decremental PEEP titration will be performed after recruitment. PEEP will be decreased from 15 to 5 cmH2O in 1-cmH2O steps, and respiratory mechanics will be assessed after 12 respiratory cycles at each level. The PEEP level associated with the lowest driving pressure will be selected as the individualized PEEP and maintained during the relevant intraoperative period.

Cerebral hemodynamics will be assessed using transcranial Doppler ultrasonography of the middle cerebral artery. Pulsatility index and resistance index will be recorded, and noninvasive estimated intracranial pressure will be calculated from the pulsatility index using the formula nICPPI = 10.93 × PI - 1.28. Transcranial Doppler measurements will be performed after anesthesia induction, 60 minutes after initiation of steep Trendelenburg position and pneumoperitoneum, and 10 minutes after termination of Trendelenburg position and pneumoperitoneum before emergence from anesthesia.

The primary outcome will be the between-group difference in the change in noninvasive estimated intracranial pressure from the post-induction measurement to the measurement obtained 60 minutes after initiation of Trendelenburg position and pneumoperitoneum (ΔnICPPI, T4-T2). Secondary assessments will include cerebral oxygenation measured using near-infrared spectroscopy, additional transcranial Doppler parameters, intraoperative hemodynamic and respiratory variables, and postoperative neurocognitive outcomes.

Postoperative attention and cognitive status will be assessed using the Months of the Year Backwards Test, delirium using the Nursing Delirium Screening Scale, and sedation/agitation using the Richmond Agitation-Sedation Scale. These assessments will be performed at predefined postoperative time points for up to 48 hours. Additional postoperative cognitive and delirium assessments will include the Mini-Mental State Examination and 3D-Confusion Assessment Method. The transcranial Doppler operator and postoperative outcome assessors will be blinded to group allocation, while the anesthesiologist performing the PEEP intervention cannot be blinded.

研究类型

介入性

注册 (估计的)

45

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

学习地点

      • Istanbul、土耳其(türkiye)、34077
        • Istanbul University-Cerrahpaşa, Cerrahpaşa Faculty of Medicine
        • 接触:
        • 副研究员:
          • Onur Kökçü
        • 首席研究员:
          • Ezgi Budak Özyalçın

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:

  • Age 18 to 80 years American Society of Anesthesiologists (ASA) physical status I-III Scheduled for robot-assisted laparoscopic radical prostatectomy Provision of written informed consent

Exclusion Criteria:

  • Body mass index (BMI) >35 kg/m² History of surgery requiring at least 1 hour of mechanical ventilation within the previous 2 weeks Severe pulmonary disease New York Heart Association (NYHA) class III-IV heart failure Progressive neuromuscular disease Known cerebrovascular malformation Head or neck anatomical conditions preventing adequate transcranial Doppler ultrasonography Refusal to participate in the study Intraoperative conversion to open surgery

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:基础科学
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:三倍

武器和干预

参与者组/臂
干预/治疗
实验性的:Individualized PEEP Group
Patients assigned to this group will undergo a recruitment maneuver followed by decremental PEEP titration from 15 to 5 cmH2O in 1-cmH2O steps. After 12 respiratory cycles at each PEEP level, the PEEP associated with the lowest driving pressure will be selected and maintained.
Following a recruitment maneuver, PEEP will be decreased from 15 to 5 cmH2O in 1-cmH2O steps. Respiratory mechanics will be assessed after 12 respiratory cycles at each step, and the PEEP level producing the lowest driving pressure will be selected as the individualized PEEP and maintained.
其他名称:
  • Driving Pressure-Guided PEEP
有源比较器:Standard PEEP Group
Patients assigned to this group will undergo a recruitment maneuver followed by standard fixed PEEP of 6 cmH2O during mechanical ventilation.
Following a recruitment maneuver, PEEP will be maintained at a fixed level of 6 cmH2O during mechanical ventilation.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Change in Noninvasive Estimated Intracranial Pressure
大体时间:After anesthesia induction and 60 minutes after initiation of steep Trendelenburg position and pneumoperitoneum
Noninvasive estimated intracranial pressure (nICPPI), expressed in mmHg, will be calculated from the middle cerebral artery pulsatility index (PI) measured by transcranial Doppler ultrasonography using the formula nICPPI = 10.93 × PI - 1.28. The outcome is the change in nICPPI from after anesthesia induction to 60 minutes after initiation of steep Trendelenburg position and pneumoperitoneum, calculated as the later value minus the post-induction value.
After anesthesia induction and 60 minutes after initiation of steep Trendelenburg position and pneumoperitoneum

次要结果测量

结果测量
措施说明
大体时间
Middle Cerebral Artery Pulsatility Index
大体时间:After anesthesia induction; 60 minutes after initiation of steep Trendelenburg position and pneumoperitoneum; and 10 minutes after termination of Trendelenburg position and pneumoperitoneum, before emergence from anesthesia
Middle cerebral artery pulsatility index (PI) will be measured using transcranial Doppler ultrasonography. PI is a dimensionless index derived from the cerebral arterial blood flow velocity waveform. PI values will be recorded at each predefined assessment time point.
After anesthesia induction; 60 minutes after initiation of steep Trendelenburg position and pneumoperitoneum; and 10 minutes after termination of Trendelenburg position and pneumoperitoneum, before emergence from anesthesia
Middle Cerebral Artery Resistance Index
大体时间:After anesthesia induction; 60 minutes after initiation of steep Trendelenburg position and pneumoperitoneum; and 10 minutes after termination of Trendelenburg position and pneumoperitoneum, before emergence from anesthesia
Middle cerebral artery resistance index (RI) will be measured using transcranial Doppler ultrasonography. RI is a dimensionless index derived from the cerebral arterial blood flow velocity waveform. RI values will be recorded at each predefined assessment time point.
After anesthesia induction; 60 minutes after initiation of steep Trendelenburg position and pneumoperitoneum; and 10 minutes after termination of Trendelenburg position and pneumoperitoneum, before emergence from anesthesia
Regional Cerebral Oxygen Saturation Measured by Near-Infrared Spectroscopy
大体时间:Before anesthesia induction; after anesthesia induction; 30 and 60 minutes after initiation of steep Trendelenburg position and pneumoperitoneum; immediately before termination of Trendelenburg position; and 10 minutes after termination, before emergence
Regional cerebral oxygen saturation (rSO2) will be measured using bilateral frontal near-infrared spectroscopy (NIRS) and expressed as a percentage (%). Left and right frontal rSO2 values will be recorded separately at each predefined intraoperative assessment time point.
Before anesthesia induction; after anesthesia induction; 30 and 60 minutes after initiation of steep Trendelenburg position and pneumoperitoneum; immediately before termination of Trendelenburg position; and 10 minutes after termination, before emergence
Months Backward Test Performance Score
大体时间:Preoperatively and at 12, 24, 36, and 48 hours after surgery
Attention and cognitive performance will be assessed using the Months Backward Test (MBT), in which participants are asked to recite the months of the year in reverse order. Performance will be rated using the detailed 0-to-10-point grading system described by Meagher et al. Higher scores indicate better test performance, based on the participant's ability to understand and engage with the task, sustain and shift attention, complete the reverse sequence, recognize or correct errors, complete the test without errors, and complete the task within the specified time.
Preoperatively and at 12, 24, 36, and 48 hours after surgery
Nursing Delirium Screening Scale Total Score
大体时间:In the post-anesthesia care unit or intensive care unit, and at 12, 24, 36, and 48 hours after surgery
Postoperative delirium symptoms will be assessed using the Nursing Delirium Screening Scale (NuDESC). The NuDESC total score ranges from 0 to 10 points, with higher scores indicating greater delirium symptom severity. The outcome will be reported as the NuDESC total score in points at each assessment.
In the post-anesthesia care unit or intensive care unit, and at 12, 24, 36, and 48 hours after surgery
Richmond Agitation-Sedation Scale Score
大体时间:In the post-anesthesia care unit or intensive care unit, and at 12, 24, 36, and 48 hours after surgery
Sedation and agitation will be assessed using the Richmond Agitation-Sedation Scale (RASS). The RASS score ranges from -5 (unarousable) to +4 (combative), with 0 indicating an alert and calm state. The outcome will be reported as the RASS score in points at each assessment.
In the post-anesthesia care unit or intensive care unit, and at 12, 24, 36, and 48 hours after surgery

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年8月19日

初级完成 (估计的)

2026年11月19日

研究完成 (估计的)

2026年11月30日

研究注册日期

首次提交

2026年8月18日

首先提交符合 QC 标准的

2026年8月23日

首次发布 (实际的)

2026年8月25日

研究记录更新

最后更新发布 (实际的)

2026年8月25日

上次提交的符合 QC 标准的更新

2026年8月23日

最后验证

2026年8月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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