Impact of Intraoperative Tidal Volume on Surgical Parameters During Flexible Ureteroscopy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Correlation Between Intraoperative Respiratory Parameters and Surgical Outcomes
研究概览
简要总结
The goal of this prospective clinical trial is to evaluate how intraoperative tidal volume settings affect surgical parameters and outcomes in adult patients undergoing flexible ureteroscopy (fURS) for kidney stones. The participant population includes patients over 18 years of age with unilateral, single renal stones located in the upper/middle calyx or renal pelvis.
This study aims to answer are:
Does intraoperative tidal volume influence operative time and surgical efficiency during fURS?
Does tidal volume affect laser energy use, lasing efficiency, stone-free rates, and complication rates (infection or bleeding)?
The investigators will compare two groups based on tidal volume recorded during anaesthesia:
Group 1: Low tidal volume (< 500 mL)
Group 2: Standard tidal volume (≥ 500 mL)
to determine whether tidal volume differences impact surgical performance and postoperative outcomes.
Participants will:
Undergo fURS performed under general anaesthesia with standard ASA monitoring, including ETCO₂ and TOF monitoring.
Have their respiratory parameters (tidal volume, peak airway pressure, PEEP, respiratory rate, ETCO₂) and surgical data (operative time, laser settings, fluoroscopy use, stone-free status) recorded during and after surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age ≥18 years
- •Unilateral, single kidney stones located in the upper or middle calyx or in the renal pelvis
排除标准
- •Chronic obstructive pulmonary disease (COPD)
- •History of abdominal, retroperitoneal, or thoracic surgery
- •Kidney anomalies
- •Stones located in the lower calyx
结局指标
主要结局
Correlation Between Intraoperative Respiratory Parameters and Surgical Outcomes
时间窗: 2 months
Respiratory parameter measured: Tidal Volume (mL/kg) Measurement tool: Anaesthesia ventilator/monitoring system Unit: milliliters per kilogram (mL/kg) Surgical outcomes assessed: Stone-free rate (%), assessed by postoperative non-contrast CT scan Operative time (minutes), recorded from surgical logs Complications, graded using the Clavien-Dindo classification The objective is to determine the statistical correlation between tidal volume and each of these surgical outcomes.
次要结局
- Correlation Between Intraoperative Respiratory Parameters and Seconder Outcomes(2 months)
研究者
Tarik Emre Sener
Assistant Professor
Marmara University