Ignite Creation Date:
2025-12-24 @ 9:48 PM
Ignite Modification Date:
2025-12-30 @ 2:00 AM
Study NCT ID:
NCT07109232
Status:
COMPLETED
Last Update Posted:
2025-08-07
First Post:
2025-07-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Surgical Position and Hemodynamics in PCNL
Sponsor:
Ataturk University
Organization:
Study Overview
Official Title:
Hemodynamic Effects of Surgical Positioning in Patients Undergoing Percutaneous Nephrolithotomy: A Prospective Study
Status:
COMPLETED
Status Verified Date:
2025-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This prospective study aims to evaluate the hemodynamic effects of different surgical positions-supine, lithotomy, and prone-in patients undergoing percutaneous nephrolithotomy (PCNL). Hemodynamic parameters are assessed using the Pressure Recording Analytical Method (PRAM) both while patients are awake and under general anesthesia. The study investigates how positioning-independently and in combination with anesthesia-influences cardiovascular function, including mean arterial pressure (MAP), heart rate (HR), cardiac index (CI), stroke volume index (SVI), pulse pressure variation (PPV), stroke volume variation (SVV), cardiac contractility parameters (dP/dtmax), arterial elastance (Ea), cardiac power index (CPI), and cardiac cycle efficiency (CCE). The findings are expected to contribute to optimizing perioperative management and enhancing patient safety during PCNL procedures.
Detailed Description:
This prospective clinical trial investigates the hemodynamic effects of different surgical positions-supine, lithotomy, and prone-in patients undergoing percutaneous nephrolithotomy (PCNL). The study evaluates hemodynamic variables both in the awake state and under general anesthesia to distinguish the individual and combined impacts of anesthesia and patient positioning on cardiovascular function.
Hemodynamic measurements are performed using the Pressure Recording Analytical Method (PRAM), a minimally invasive technique that allows continuous assessment of parameters such as mean arterial pressure (MAP), heart rate (HR), cardiac index (CI), pulse pressure variation (PPV), stroke volume variation (SVV), stroke volume index (SVI), cardiac contractility parameters (dP/dtmax), arterial elastance (Ea), cardiac power index (CPI), and cardiac cycle efficiency (CCE). Each patient is sequentially positioned in the three surgical positions while awake, and the same measurements are repeated after the induction of general anesthesia in the corresponding positions.
The primary aim is to determine how surgical positioning under general anesthesia alters key cardiovascular parameters. Secondary objectives include comparing hemodynamic changes across positions in both conscious and anesthetized states, identifying potential risks associated with specific positions, and guiding intraoperative patient management to improve safety and outcomes in PCNL procedures.
The study is conducted at a single center and includes adult patients with ASA physical status I-II scheduled for elective PCNL surgery. The findings are expected to provide valuable data for anesthesiologists and surgeons to optimize perioperative cardiovascular stability, particularly during position changes in urological surgeries.
Hemodynamic measurements are performed using the Pressure Recording Analytical Method (PRAM), a minimally invasive technique that allows continuous assessment of parameters such as mean arterial pressure (MAP), heart rate (HR), cardiac index (CI), pulse pressure variation (PPV), stroke volume variation (SVV), stroke volume index (SVI), cardiac contractility parameters (dP/dtmax), arterial elastance (Ea), cardiac power index (CPI), and cardiac cycle efficiency (CCE). Each patient is sequentially positioned in the three surgical positions while awake, and the same measurements are repeated after the induction of general anesthesia in the corresponding positions.
The primary aim is to determine how surgical positioning under general anesthesia alters key cardiovascular parameters. Secondary objectives include comparing hemodynamic changes across positions in both conscious and anesthetized states, identifying potential risks associated with specific positions, and guiding intraoperative patient management to improve safety and outcomes in PCNL procedures.
The study is conducted at a single center and includes adult patients with ASA physical status I-II scheduled for elective PCNL surgery. The findings are expected to provide valuable data for anesthesiologists and surgeons to optimize perioperative cardiovascular stability, particularly during position changes in urological surgeries.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: