跳至主要内容
临床试验/NCT06944301
NCT06944301尚未招募不适用

Comparison of Myocardial Injury After Noncardiac Surgery (MINS) Incidence in Supine vs. Prone Positioning During Percutaneous Nephrolithotomy (PNL)

Medipol University0 个研究点目标入组 400 人开始时间: 2025年6月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
400
主要终点
Incidence of Myocardial Injury after Noncardiac Surgery (MINS)

研究概览

简要总结

This prospective cohort study aims to compare the incidence of Myocardial Injury after Noncardiac Surgery (MINS) in patients undergoing percutaneous nephrolithotomy (PNL) for kidney stones in supine versus prone positioning. MINS is defined as an elevated postoperative troponin level (≥0.03 ng/mL) within 48 hours after surgery. Approximately 400 patients will be enrolled, with 200 patients in each positioning group (supine and prone). The primary outcome is the incidence of MINS, assessed through troponin measurements and electrocardiogram (ECG) findings. Secondary outcomes include intraoperative complications, duration of surgery, and postoperative recovery metrics. The study seeks to determine whether surgical positioning impacts MINS risk, potentially guiding safer surgical practices.

详细描述

Myocardial Injury after Noncardiac Surgery (MINS) is a significant perioperative complication associated with increased morbidity and mortality. This study investigates whether surgical positioning (supine vs. prone) during percutaneous nephrolithotomy (PNL) influences the incidence of MINS. Patients aged 18 years and older undergoing PNL for kidney stones will be enrolled in a prospective cohort study at [Institution Name]. Exclusion criteria include pre-existing cardiovascular disease, elevated baseline troponin levels, or major intraoperative complications. Approximately 400 patients will be divided into two groups based on surgical positioning: 200 in the supine group and 200 in the prone group. Troponin levels will be measured preoperatively and at 24 and 48 hours postoperatively, with MINS defined as a troponin T level ≥0.03 ng/mL. Electrocardiograms (ECGs) will be performed to detect ischemic changes. Secondary outcomes include intraoperative hypotension, surgical duration, and postoperative hospital stay. Data will be analyzed using chi-square tests and logistic regression to adjust for confounders such as age, comorbidities, and surgical duration. The study aims to provide evidence on the impact of positioning on MINS, potentially informing safer surgical protocols for PNL.

研究设计

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

入排标准

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

入选标准

  • Age ≥40 years.
  • Patients undergoing percutaneous nephrolithotomy (PNL) for kidney stones.
  • Willing and able to provide informed consent.

排除标准

  • Known coronary artery disease, heart failure, or other significant cardiovascular conditions.
  • Elevated preoperative troponin levels (≥0.03 ng/mL).
  • Major intraoperative complications (e.g., severe bleeding requiring transfusion).
  • Inability to comply with study procedures.

结局指标

主要结局

Incidence of Myocardial Injury after Noncardiac Surgery (MINS)

时间窗: Up to 48 hours post-surgery

Proportion of patients with postoperative troponin T levels ≥0.03 ng/mL within 48 hours after PNL, confirmed by ECG findings if ischemic changes are present.

次要结局

  • Surgical Duration(During surgery.)
  • Postoperative Hospital Stay(From surgery to discharge.)

研究者

发起方
Medipol University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ali Ihsan Memmi

medical doctor

Medipol University

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