Can High Ventilation Mode Achieve Higher Success Rates in Retrograde Intrarenal Surgery? Single-Blind Randomized, Prospective, Single-Center Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 140
- 试验地点
- 2
- 主要终点
- perioperatively data of RIRS procedure according to different ventilatation modes
研究概览
简要总结
RIRS (Retrograde Intrarenal Surgery) has been accepted as a first-line treatment option for urinary stones smaller than 2 cm and is generally performed under general anesthesia to manipulate respirator-related renal mobility. Many surgeons prefer general anesthesia during RIRS to minimize respiration-related renal mobility. Standard mechanical ventilation settings were still inadequate to limit renal mobility and the surgeons tried to find the most effective ventilation mode to minimize renal mobility.
详细描述
A standard general anesthesia protocol is given to all patients by the same anesthesiologist. A Drager Primus (Germany) mechanic ventilator (MV) is preferred for general anesthesia. The MV will determine the tidal volume and respiration frequency according to the patient's age and weight with end-tidal CO2 levels of 30-35 mmHg. Standard ventilation mode is 8-10 mL/kg tidal volume and 10-15 respirations/min. During HV mode, the tidal volume will decrease to 6-8 mL/kg and the frequency will increase to 15-18 respirations/min. No changes are made in the inspiratory expiratory ratio (1:2), FiO2, and positive end-expiratory pressure (PEEP) parameters. The ventilation mode of the mechanic ventilator (SV or HV) is determined via randomization software before the surgery. According to randomization, the anesthesiologist is informed about the ventilation mode but the surgeons are absolutely blind. A high ventilation mode is formed by increasing the respiration frequency and decreasing the study's tidal volume. The aim of the study was to evaluate the effect of this mode on the efficacy and safety of RIRS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Investigator)
盲法说明
According to randomization, the anesthesiologist is informed about the ventilation mode but the surgeons are absolutely blind. The surgeons will perform the RIRS without knowing the type of ventilation mode.
入排标准
- 年龄范围
- 18 Years 至 86 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who underwent RIRS with kidney stones older than18 y.o
排除标准
- •Patients younger than 18 years old Patients with a known respiratory disease Patients with a renal anomaly Proximal ureteral stones, or stones with multiple locations The patients who underwent previous ipsilateral percutaneous nephrolithotomy and/or open renal surgery were excluded from the study.
结局指标
主要结局
perioperatively data of RIRS procedure according to different ventilatation modes
时间窗: During the surgical procedure
perioperatively data including e.g. operation time
Complicatation of perioperatively during RIRS
时间窗: During the surgical procedure
The presence of perioperative bleeding, perioperative bleeding, ureteral perforation, bladder perforation, ureteral avulsion
次要结局
- Post operative success rates(At the postoperative first month of surgery)
- Post operative complication(From postoperative first day to postoperative 1. month)
研究者
Cagri DOGAN
Assistant.Prof
Namik Kemal University