Clinical trial NCT06944301: Comparison of Myocardial Injury After Noncardiac Surgery (MINS) Incidence in Supine vs. Prone Positioning During Percutaneous Nephrolithotomy (PNL)
Official title: Comparison of Myocardial Injury After Noncardiac Surgery (MINS) Incidence in Supine vs. Prone Positioning During Percutaneous Nephrolithotomy (PNL)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: MINS
Myocardial Injury After Noncardiac Surgery
Myocardial Injury After Noncardiac Surgery (MINS)
Renal Calculi
Renal Stones
Percutaneous Nephrolithotomy (PNL)
Nephrolithiasis
Keywords: MINS
PNL
percutaneous nephrolithotomy
Myocardial Injury after Noncardiac Surgery
prone
supine
Lead sponsor: Medipol University
Sponsor class: OTHER
Collaborators: name: Istanbul Medipol University Hospital
First posted: 2025-04-25
Enrollment: 400
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Incidence of Myocardial Injury after Noncardiac Surgery (MINS)
timeFrame: Up to 48 hours post-surgery
Secondary outcomes:
measure: Surgical Duration
timeFrame: During surgery.
measure: Postoperative Hospital Stay
timeFrame: From surgery to discharge.
Other outcomes:
Locations:
Study officials:
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