NCT07340333

Physiological Reference Values of Total Arterial Impedance Derived From PRAM Monitoring

Reference Values and Hemodynamic Associations of Total Arterial Impedance Derived From PRAM Monitoring During Hemodynamically Stable Intraoperative Periods

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 437 (actual)
• Sponsor: Ataturk University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Total arterial impedance (Ztot) is an advanced hemodynamic parameter that reflects the global arterial load opposing ventricular ejection by integrating both steady and pulsatile components of the arterial system. Although Ztot can be continuously derived from Pressure Recording Analytical Method (PRAM)-based monitoring, physiological reference values under stable clinical conditions are not well established. This observational study aims to define patient-level physiological reference values for Ztot using intraoperative hemodynamic data obtained from PRAM-based arterial waveform analysis during hemodynamically stable periods. In addition, the study evaluates the associations between Ztot and key hemodynamic variables reflecting arterial load and cardiovascular performance. High-resolution intraoperative data routinely recorded during standard clinical care are retrospectively analyzed. The findings of this study are intended to improve the interpretability of Ztot in advanced hemodynamic monitoring and to support future clinical and research applications.

Detailed description

Total arterial impedance (Ztot) is a comprehensive descriptor of arterial load that integrates resistive, compliant, and pulsatile components of the arterial system. Unlike conventional pressure-based parameters, Ztot provides a more physiologically meaningful representation of the opposition encountered by ventricular ejection. Although Ztot can be continuously estimated using Pressure Recording Analytical Method (PRAM)-based arterial waveform analysis, standardized physiological reference values applicable to routine clinical practice are lacking. This single-center, observational study is designed to establish patient-level reference values for PRAM-derived Ztot during hemodynamically stable intraoperative periods. The study retrospectively analyzes high-resolution intraoperative hemodynamic data obtained during routine clinical care. Adult surgical patients monitored with an invasive arterial catheter and PRAM-based hemodynamic monitoring are included in the analysis. Hemodynamic stability is defined according to predefined physiological criteria, including ranges of mean arterial pressure, cardiac index, heart rate, stroke volume variation, cardiac cycle efficiency, and arterial waveform quality indicators. Only measurements meeting all stability criteria are considered eligible for analysis. To account for repeated measurements within individuals, patient-level median values are used for all primary analyses. The physiological reference interval for Ztot is estimated using a non-parametric percentile-based approach. In addition, associations between Ztot and key hemodynamic variables related to arterial load and cardiovascular performance are explored using correlation analyses. This study does not involve any interventions, treatment assignments, or changes to standard clinical management. The primary objective is descriptive and physiological, aiming to provide a reference framework that may enhance the clinical interpretability of Ztot in advanced hemodynamic monitoring. The results are expected to support future prospective and outcome-oriented research evaluating the role of Ztot in perioperative and critical care settings.

Conditions

• Intraoperative Hemodynamics

Timeline

• Start date: 2026-01-30
• Primary completion: 2026-02-02
• Completion: 2026-02-02
• First posted: 2026-01-14
• Last updated: 2026-02-04

Locations

1 site across 1 country: Turkey (Türkiye)