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临床试验/NCT07289113
NCT07289113招募中不适用

Personalized PEEP Titration Guided by Electrical Impedance Tomography in Patients Undergoing Laparoscopic Surgery: A Randomized Controlled Trial - The PEaRL Study

ASST Fatebenefratelli Sacco1 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2026年1月12日最近更新:
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
52
试验地点
1
主要终点
Static respiratory system compliance

研究概览

简要总结

Background:

Laparoscopic surgery has gained widespread adoption due to its minimally invasive nature, offering advantages such as reduced postoperative pain, shorter hospitalization, and faster functional recovery compared with traditional open surgery. Nevertheless, postoperative respiratory complications remain a major source of morbidity. Factors such as general anesthesia, the Trendelenburg position, and CO₂ pneumoperitoneum can impair respiratory mechanics, reduce total lung capacity, and promote atelectasis, leading to compromised gas exchange.

Rationale:

Positive end-expiratory pressure (PEEP) is routinely applied to prevent alveolar collapse and improve oxygenation during mechanical ventilation. However, the use of standardized, non-individualized PEEP levels may be suboptimal, as inappropriate settings can cause alveolar overdistension or persistent collapse. Personalized PEEP titration, tailored to patient-specific lung mechanics, has recently emerged as a promising strategy to minimize ventilator-induced lung injury (VILI).

Methods and Tools:

Electrical Impedance Tomography (EIT) is a non-invasive, bedside monitoring technique that enables real-time assessment of regional lung ventilation. By evaluating ventilated and non-ventilated lung areas, EIT can guide PEEP optimization and support individualized ventilatory management. Recent studies suggest that EIT-guided PEEP titration improves respiratory parameters and reduces atelectasis in patients undergoing major surgery.

Objective:

The present study aims to evaluate the efficacy of EIT-guided PEEP personalization in patients undergoing laparoscopic and robotic surgery. Primary endpoints include improvements in regional ventilation, respiratory system compliance, and intraoperative gas exchange, as well as postoperative pulmonary function.

详细描述

Laparoscopic surgery has become an increasingly widespread surgical approach due to its minimally invasive nature, which allows for reduced postoperative pain, shorter hospital stays, and faster functional recovery compared to traditional open surgery. However, despite these advantages, laparoscopic procedures are not free from postoperative respiratory complications, which remain among the leading causes of postoperative morbidity. The combination of general anesthesia, the Trendelenburg position, and insufflation of CO₂ into the abdominal cavity can alter respiratory mechanics, reduce total lung capacity, and promote the development of atelectatic areas, resulting in impaired gas exchange (1-2).

Positive end-expiratory pressure (PEEP) is a widely used strategy to prevent alveolar collapse and improve oxygenation during mechanical ventilation. Nevertheless, the application of a standardized, non-individualized PEEP level may not be optimal for all patients, and an inappropriate PEEP setting may lead to alveolar overdistension or persistence of collapsed areas (3). Recently, personalized PEEP titration has gained attention as a method to tailor ventilation settings to individual patient characteristics, thereby minimizing the risk of ventilator-induced lung injury (VILI) (4).

Electrical Impedance Tomography (EIT) is a non-invasive, bedside imaging technique that enables real-time assessment of the regional distribution of pulmonary ventilation. EIT allows continuous monitoring of the effects of PEEP on both ventilated and non-ventilated lung regions and can guide the optimization of individualized PEEP levels to improve ventilation distribution and reduce the risk of respiratory complications (5-6). Recent studies have shown that the use of EIT-guided PEEP personalization in patients undergoing major surgery can improve respiratory parameters and reduce atelectasis formation (7-8). Specifically, EIT enables the performance of a PEEP trial, during which the device identifies areas of alveolar overdistension or collapse in response to PEEP changes, thereby guiding personalized ventilatory settings.

However, the application of this technique in the context of laparoscopic surgery remains limited. This study aims to evaluate the effectiveness of EIT-guided PEEP personalization in patients undergoing laparoscopic and robotic procedures, with the goal of improving regional ventilation, respiratory system compliance, and intraoperative gas exchange, as well as postoperative pulmonary function.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • scheduled for laparoscopic abdominal surgery
  • informed consent signed

排除标准

  • Acute respiratory failure
  • Hemodynamic instability
  • Pregnancy
  • Contraindications for EIT device

研究组 & 干预措施

Standard PEEP

No Intervention

PEEP value will be decided by clinician

EIT PEEP

Experimental

PEEP value will be set after a PEEP trial performed with EIT machine

干预措施: A PEEP trial performed with the PulmoVista® 500 (Dräger, Lübeck, Germany) is a procedure designed to identify the optimal level of positive end-expiratory pressure (Device)

结局指标

主要结局

Static respiratory system compliance

时间窗: - Baseline (after anesthesia induction) - T1 (After Trendelemburg position and induction of pneumoperitoneum) - T2 (After PEEP trial) - T3 (90 minutes after PEEP trial) - T4 (180 minutes after PEEP trial) - T5 (Before end of anesthesia)

Respiratory system compliance is equivalent to tidal volume divided by the diiference between plateau and PEEP pressure. Unit of measurement is cmH2O/mL

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Tommaso Fossali

Medical Doctor, head of the anesthesiologists

ASST Fatebenefratelli Sacco

研究点 (1)

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