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Comparison of Different Ventilation Modes for Reducing Kidney Motion During Retrograde Intrarenal Surgery (RIRS-VENT)

2026年7月10日 更新者：Tuna Erturk、Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey

Comparison of Different Ventilation Modes for Reducing Kidney Motion During Retrograde Intrarenal Surgery: A Prospective Randomized Controlled Trial

This randomized clinical trial will compare four ventilation strategies during retrograde intrarenal surgery performed under general anesthesia. The study aims to determine whether reducing respiratory-related kidney movement improves surgical success and decreases perioperative complications. Eighty adult patients will be randomly assigned to standard ventilation, hypoventilation, intermittent apnea ventilation, or one-lung ventilation. Surgical outcomes and perioperative complications will be compared between groups.

研究概览

地位

尚未招聘

条件

干预/治疗

详细说明

Retrograde intrarenal surgery is commonly performed under general anesthesia, but respiratory movement may interfere with kidney stability during the procedure. This prospective, randomized, single-center trial will compare standard ventilation, hypoventilation, intermittent apnea ventilation, and one-lung ventilation in adult patients undergoing retrograde intrarenal surgery. The primary objective is to determine whether different ventilation strategies improve surgical success by reducing kidney movement. Secondary outcomes include operative time, stone access time, fluoroscopy time, laser use time, complications, length of hospital stay, and postoperative stone-free rate.

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

研究联系人备份

学习地点

  • 土耳其（türkiye）
    • Istanbul
      • Istanbul、Istanbul、土耳其（türkiye）、34668
        • Sultan Abdulhamid Han Training and Research Hospital
        • 接触：
        • 接触：
        • 首席研究员：
          • Tuna Ertürk, MD
        • 副研究员：
          • Hakan Emirkadı, MD

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 18-75 years. ASA physical status I-III. Scheduled for elective RIRS/RIRC under general anesthesia. No obstructive or restrictive pulmonary disease. No history of pneumothorax. No pulmonary mass or other significant respiratory disease. Normal coagulation parameters and not receiving antithrombotic therapy. No active urinary tract infection. Written informed consent.

Exclusion Criteria:

Age <18 or >75 years. ASA IV. Obstructive or restrictive pulmonary disease. History of pneumothorax. Pulmonary mass or significant respiratory disease. Receiving antithrombotic therapy or abnormal coagulation. Active urinary tract infection or urinary tract anatomical abnormality. Refusal or inability to provide informed consent.

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：随机化
  • 介入模型：并行分配
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
有源比较器：Standard Ventilation
Patients will receive standard volume-controlled mechanical ventilation during retrograde intrarenal surgery under general anesthesia.
程序：Standard Ventilation
Volume-controlled mechanical ventilation using standard ventilator settings during general anesthesia.
实验性的：Hypoventilation
Patients will receive hypoventilation with reduced tidal volume and respiratory rate during retrograde intrarenal surgery under general anesthesia.
程序：Hypoventilation
Volume-controlled mechanical ventilation using reduced tidal volume and respiratory rate during general anesthesia.
实验性的：Intermittent Apnea Ventilation
Patients will receive intermittent apnea periods during selected surgical steps, in coordination with the surgeon.
程序：Intermittent Apnea Ventilation
Intermittent apnea periods applied during selected stages of retrograde intrarenal surgery to reduce kidney motion.
实验性的：One-Lung Ventilation
Patients will receive one-lung ventilation during selected surgical steps, in coordination with the surgeon.
程序：One-Lung Ventilation
One-lung ventilation applied during selected stages of retrograde intrarenal surgery to reduce kidney motion.

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
Kidney Motion During Retrograde Intrarenal Surgery
大体时间：During surgery
Kidney motion during surgery will be evaluated and compared among the four ventilation strategies.
During surgery

次要结果测量

结果测量
措施说明
大体时间
Stone-free Rate
大体时间：Postoperative Day 30
Percentage of patients who are stone-free after retrograde intrarenal surgery.
Postoperative Day 30
Operative Time
大体时间：During surgery
Total duration of surgery measured from the beginning to the end of the surgical procedure.
During surgery
Fluoroscopy Time
大体时间：During surgery
Total fluoroscopy exposure time recorded during the procedure.
During surgery
Laser Activation Time
大体时间：During surgery
Total duration of laser use during stone fragmentation.
During surgery
Perioperative Complications
大体时间：Periprocedural
Occurrence of intraoperative and postoperative complications.
Periprocedural
Length of Hospital Stay
大体时间：Periprocedural
Number of days of hospitalization.
Periprocedural

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

Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey

调查人员

  • 首席研究员：Tuna Ertürk, MD、University of Health Sciences Sultan 2. Abdulhamid Han 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 (估计的)

2026年7月15日

初级完成 (估计的)

2026年11月15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7月5日

首先提交符合 QC 标准的

2026年7月10日

首次发布 (实际的)

2026年7月15日

研究记录更新

最后更新发布 (实际的)

2026年7月15日

上次提交的符合 QC 标准的更新

2026年7月10日

最后验证

2026年7月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • 21-64

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

Individual participant data will not be made publicly available to protect participant confidentiality.

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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