Surgical Position and Hemodynamics in PCNL

NCT ID: NCT07109232

Last Updated: 2025-08-07

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 40 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-05-15
• Study Completion Date: 2023-05-15

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.

Conditions

Hemodynamic Changes; Surgical Positioning; Percutaneous Nephrolithotomy (PCNL)

Study Design

• Observational Model Type: CASE_CROSSOVER
• Study Time Perspective: PROSPECTIVE

Study Groups

Hemodynamic Response to Position Changes

Hemodynamic variables-including mean arterial pressure (MAP), heart rate (HR), cardiac index (CI), stroke volume index (SVI), pulse pressure variation (PPV), stroke volume variation (SVV), dP/dtmax, arterial elastance (Ea), cardiac cycle efficiency (CCE), and cardiac power index (CPI)-were continuously monitored. Hemodynamic measurements were obtained at six predefined time points using the Pressure Recording Analytical Method (PRAM).

The first three measurements were recorded during the pre-anesthetic period in the supine, lithotomy, and prone positions, respectively, prior to the induction of anesthesia. The latter three measurements were obtained during the anesthetized period: five minutes after induction while the patient was in the baseline supine position, five minutes after transitioning to the lithotomy position (prior to ureteral catheter placement), and five minutes after repositioning to the prone position, before surgical incision.

Position the patient

Intervention Type: OTHER

In addition, prior to the operation and throughout the PCNL procedure, hemodynamic measurements were obtained while patients were positioned in the supine, lithotomy, and prone positions, as necessitated by the surgical protocol.

Interventions

Position the patient

In addition, prior to the operation and throughout the PCNL procedure, hemodynamic measurements were obtained while patients were positioned in the supine, lithotomy, and prone positions, as necessitated by the surgical protocol.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

Participants must be between 18 and 65 years of age. Participants must have a body mass index (BMI) of less than 30 kg/m². Participants must be classified as American Society of Anesthesiologists (ASA) physical status I or II.

Participants must be scheduled to undergo elective percutaneous nephrolithotomy (PCNL) surgery.

Exclusion Criteria

Participants with a known history of cardiac disease, including arrhythmia, valvular heart disease, prior cardiac surgery, presence of a pacemaker, or an implanted cardiac defibrillator, will be excluded.

Participants with renal failure will be excluded. Participants who received colloid fluid administration prior to surgery will be excluded.

Participants using vasoactive or inotropic drugs will be excluded.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ataturk University

OTHER

Sponsor Role: lead

Responsible Party

Erkan Cem ÇELİK

Associate Professor MD.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Atatürk University Faculty of Medicine

Erzurum, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

Lee S, Kim DY, Han J, Kim K, You AH, Kang HY, Park SW, Kim MK, Kim JE, Choi JH. Hemodynamic changes in the prone position according to fluid loading after anaesthesia induction in patients undergoing lumbar spine surgery: a randomized, assessor-blind, prospective study. Ann Med. 2024 Dec;56(1):2356645. doi: 10.1080/07853890.2024.2356645. Epub 2024 May 24.

Reference Type: BACKGROUND

PMID: 38794845 (View on PubMed)

Romagnoli S, Franchi F, Ricci Z, Scolletta S, Payen D. The Pressure Recording Analytical Method (PRAM): Technical Concepts and Literature Review. J Cardiothorac Vasc Anesth. 2017 Aug;31(4):1460-1470. doi: 10.1053/j.jvca.2016.09.004. Epub 2016 Sep 14. No abstract available.

Reference Type: BACKGROUND

PMID: 28012725 (View on PubMed)

Other Identifiers

Ataunihemo

Identifier Type: -

Identifier Source: org_study_id