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临床试验/NCT07705646
NCT07705646尚未招募不适用

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

Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2026年7月15日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
80
试验地点
1
主要终点
Kidney Motion During Retrograde Intrarenal Surgery

研究概览

简要总结

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.

详细描述

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.

研究设计

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

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

Kidney Motion During Retrograde Intrarenal Surgery

时间窗: During surgery

Kidney motion during surgery will be evaluated and compared among the four ventilation strategies.

次要结局

  • Length of Hospital Stay(Periprocedural)
  • Stone-free Rate(Postoperative Day 30)
  • Operative Time(During surgery)
  • Fluoroscopy Time(During surgery)
  • Laser Activation Time(During surgery)
  • Perioperative Complications(Periprocedural)

研究者

发起方
Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
申办方类型
Other
责任方
Principal Investigator
主要研究者

Tuna Erturk

Principal Investigator

Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey

研究点 (1)

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