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Mechanical Power During Different Ventilation Modes in Laparoscopic Surgery

2026年7月7日 更新者：Arif Timuroğlu, MD、Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital

Comparison of Mechanical Power in Pressure-Regulated Volume Control and Volume-Controlled Ventilation Modes During Laparoscopic Cholecystectomy

This study investigates how different breathing machine (ventilator) settings affect the energy delivered to the lungs during surgery. Mechanical power is a measure of this energy, and high levels can sometimes lead to lung irritation. In clinical practice, a mode called Pressure-Regulated Volume Control (PRVC) is often used because it lowers the "peak" pressure in the airways, which is generally thought to be safer. However, doctors have noticed that even though the peak pressure goes down in PRVC mode, the total mechanical power displayed on the monitor might actually increase compared to the standard Volume-Controlled Ventilation (VCV) mode. In this study, patients undergoing gallbladder surgery will be monitored using both ventilation modes in a random order. The researchers will compare the machine-calculated mechanical power for both modes to see if the perceived benefit of lower peak pressure in PRVC actually results in lower overall energy transfer to the lungs.

研究概览

地位

招聘中

条件

干预/治疗

研究类型

介入性

注册 (估计的)

80

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

  • 土耳其（türkiye）
    • Ankara
      • Yenimahalle、Ankara、土耳其（türkiye）、06370
        • 招聘中
        • Dr. Abdurrahman Yurtaslan Ankara Oncology Hospital
        • 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

是的

描述

Inclusion Criteria:

  • Patients undergoing elective laparoscopic cholecystectomy surgery.
  • Patients between 18 and 75 years of age.
  • American Society of Anesthesiologists (ASA) physical status I, II or III.
  • Body Mass Index (BMI) between 18.5 and 35 kg/m².
  • Voluntary written informed consent for participation.

Exclusion Criteria:

  • History of significant chronic obstructive pulmonary disease (COPD) or asthma.
  • Previous lung resection or major thoracic surgery.
  • Heavy smokers (more than 20 cigarettes per day).
  • Presence of spontaneous breathing effort during mechanical ventilation.
  • Conversion from laparoscopic surgery to open surgery during the procedure.
  • Emergency surgery cases.
  • Known pregnancy.

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：交叉作业
  • 屏蔽：单身的

武器和干预

参与者组/臂
干预/治疗
实验性的：group A; VCV First, Then PRVC
Following the stabilization of pneumoperitoneum, participants will be ventilated using the Volume-Controlled Ventilation (VCV) mode for 10 minutes. At the end of this period, respiratory data and mechanical power values will be recorded. Immediately after, the ventilator will be switched to the Pressure-Regulated Volume Control (PRVC) mode with equivalent settings. After another 10-minute stabilization period in PRVC mode, a second set of measurements will be recorded.
设备：Volume-Controlled Ventilation (VCV)
Participants will be ventilated with the traditional Volume-Controlled Ventilation (VCV) mode. Tidal volume, respiratory rate, PEEP, and I:E ratio will be set according to the study protocol and kept constant during the measurement period.
设备：Pressure-Regulated Volume Control (PRVC)
Participants will be ventilated with the Pressure-Regulated Volume Control (PRVC) mode. This is a hybrid mode that uses a decelerating flow to deliver the target tidal volume at the lowest possible pressure. Settings will be identical to the VCV mode for each patient.
实验性的：group B; PRVC First, Then VCV
Following the stabilization of pneumoperitoneum, participants will be ventilated using the Pressure-Regulated Volume Control (PRVC) mode for 10 minutes. At the end of this period, respiratory data and mechanical power values will be recorded. Immediately after, the ventilator will be switched to the Volume-Controlled Ventilation (VCV) mode with equivalent settings. After another 10-minute stabilization period in VCV mode, a second set of measurements will be recorded.
设备：Volume-Controlled Ventilation (VCV)
Participants will be ventilated with the traditional Volume-Controlled Ventilation (VCV) mode. Tidal volume, respiratory rate, PEEP, and I:E ratio will be set according to the study protocol and kept constant during the measurement period.
设备：Pressure-Regulated Volume Control (PRVC)
Participants will be ventilated with the Pressure-Regulated Volume Control (PRVC) mode. This is a hybrid mode that uses a decelerating flow to deliver the target tidal volume at the lowest possible pressure. Settings will be identical to the VCV mode for each patient.

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
Device-Displayed Mechanical Power
大体时间：At the end of a 10-minute stabilization period in each ventilation mode (VCV and PRVC).
The mechanical power value (expressed in Joules per minute - J/min) is automatically calculated and displayed on the monitor of the Mindray A9 anesthesia machine. This value represents the total energy delivered by the ventilator to the patient's respiratory system per minute. The study aims to compare how this machine-calculated value differs between the Volume-Controlled Ventilation (VCV) and Pressure-Regulated Volume Control (PRVC) modes under identical clinical conditions.
At the end of a 10-minute stabilization period in each ventilation mode (VCV and PRVC).

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。

赞助

Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital

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7月1日

初级完成 (估计的)

2026年8月10日

研究完成 (估计的)

2026年8月12日

研究注册日期

首次提交

2026年6月22日

首先提交符合 QC 标准的

2026年6月22日

首次发布 (实际的)

2026年6月26日

研究记录更新

最后更新发布 (实际的)

2026年7月8日

上次提交的符合 QC 标准的更新

2026年7月7日

最后验证

2026年7月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • 2026-06/133

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

IPD 计划说明

The de-identified individual participant data (including study protocol and statistical analysis plan) will be made available upon reasonable request to the corresponding author, following the publication of the study results.

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

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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