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Effect of Individualized Positive End-expiratory Pressure (PEEP) in Patients Who Have an Intrinsic PEEP During One-lung Ventilation

2026年9月9日 更新者:Hyun Joo Ahn、Samsung Medical Center

Effects of Individualized Positive End-expiratory Pressure (PEEP) on Intrinsic PEEP and Stroke Volume During One-lung Ventilation: a Single-center, Randomized Crossover Study

This study investigates the effects of three extrinsic PEEP settings-5 cmH2O, 0 cmH2O, and an individualized PEEP (70% of the measured intrinsic PEEP)-on intrinsic PEEP and hemodynamic stability in patients with intrinsic PEEP undergoing lung resection surgery, using a randomized, crossover design.

研究概览

详细说明

Intrinsic positive end-expiratory pressure (iPEEP) frequently occurs during one-lung ventilation (OLV), which is essential for lung resection. This occurrence is driven by three primary factors. First, a significant portion of patients undergoing lung surgery have concomitant chronic obstructive pulmonary disease (COPD) and thus possess a baseline intrinsic PEEP. Second, high-frequency ventilation applied to prevent carbon dioxide accumulation during OLV shortens the expiratory time, thereby generating intrinsic PEEP. Third, the use of a narrow-bore double-lumen endobronchial tube for OLV increases airway resistance, accelerating the development of intrinsic PEEP. Intrinsic PEEP causes lung hyperinflation and elevates intrathoracic pressure, which can subsequently decrease venous return and lead to abrupt hypotension. However, research remains insufficient regarding the optimal level of extrinsic PEEP for patients who develop intrinsic PEEP during OLV. While an extrinsic PEEP of around 5 cmH2O is generally applied during OLV, some guidelines recommend completely removing extrinsic PEEP (0 cmH2O) during OLV in COPD patients. Nevertheless, this recommendation lacks robust scientific evidence. Furthermore, whether the strategy of setting extrinsic PEEP at approximately 70% of intrinsic PEEP-as suggested by studies in critically ill patients-is equally valid in the intraoperative OLV environment remains unverified. Theoretically, if extrinsic PEEP exceeds intrinsic PEEP, it may exacerbate lung hyperinflation by increasing expiratory resistance. Conversely, an extrinsic PEEP that is too low may cause airway collapse during expiration, paradoxically worsening gas trapping. Therefore, this study aims to evaluate the effects of three extrinsic PEEP settings-5 cmH2O, 0 cmH2O, and an individualized PEEP (70% of the measured intrinsic PEEP)-on intrinsic PEEP and hemodynamic stability using a randomized, crossover design.

研究类型

介入性

注册 (估计的)

48

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

研究联系人备份

学习地点

      • Seoul、韩国、06351
        • 招聘中
        • Samsung Medical Center
        • 接触:
          • Anesthesiologist, Professor, MD, PhD
          • 电话号码:+82-2-3410-0784
          • 邮箱:hyunjooahn@skku.edu
        • 接触:

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:

  • American Society of Anesthesiologists Physical Status I - III
  • The Eastern Cooperative Oncology Group Performance Status Grade 0 - 2
  • Lung resection surgery requiring one-lung ventilation for over 60 minutes
  • Indication of double-lumen endobronchial tube (female 35 Fr, male 37 Fr)
  • Patient who is diagnosed with intrinsic PEEP during one-lung ventilation

Exclusion Criteria:

  • Large bullae
  • Emergency surgery
  • Mechanical ventilation before surgery
  • Hemodynamic instability before surgery
  • Surgery requiring cardiopulmonary bypass
  • Pregnancy, breastfeeding patient
  • Patient's refusal to participate
  • No intrinsic PEEP during one-lung ventilation

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:治疗
  • 分配:不适用
  • 介入模型:单组作业
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:Experimental group
During one-lung ventilation, baseline intrinsic PEEP and stroke volume will be measured. All participants will receive three PEEP interventions: 0 cmH2O, 5 cmH2O, and 70% of the intrinsic PEEP value. The order of interventions is randomized. Each intervention will be maintained for 5 minutes, with a 5-minute washout period between interventions to minimize mutual interference. At the end of each intervention, two primary outcomes (intrinsic PEEP and stroke volume) will be measured.
PEEP 0 (zero) means off-PEEP on the anesthesia machine.
PEEP5 means setting the PEEP to 5 cmH2O on the anesthesia machine.
PEEPi (individualized PEEP) means setting the PEEP to 70% of intrinsic PEEP on the anesthesia machine.

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
Intrinsic positive end-expiratory airway pressure
大体时间:During a 30-minute period from the start of one-lung ventilation to the completion of the intervention
During one-lung ventilation, each patient will randomly receive three PEEP interventions: 0 cmH2O, 5 cmH2O, and the 70% value of intrinsic PEEP. After each 5-minute intervention, intrinsic PEEP will be measured by the anesthesia machine.
During a 30-minute period from the start of one-lung ventilation to the completion of the intervention
Stroke volume
大体时间:During a 30-minute period from the start of one-lung ventilation to the completion of the intervention
During one-lung ventilation, each patient will randomly receive three PEEP interventions: 0 cmH2O, 5 cmH2O, and the 70% value of intrinsic PEEP. After each 5-minute intervention, Stroke volume will be measured by an arterial pressure-based cardiac output monitor.
During a 30-minute period from the start of one-lung ventilation to the completion of the intervention

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。

调查人员

  • 首席研究员:Hyun Joo Ahn, MD, PhD、Samsung Medical Center

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 (实际的)

2026年8月1日

初级完成 (估计的)

2027年5月31日

研究完成 (估计的)

2027年5月31日

研究注册日期

首次提交

2026年5月21日

首先提交符合 QC 标准的

2026年6月4日

首次发布 (实际的)

2026年6月10日

研究记录更新

最后更新发布 (实际的)

2026年9月14日

上次提交的符合 QC 标准的更新

2026年9月9日

最后验证

2026年6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)?

未定

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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