NCT07037225

Study of Cardiac Power Index During Supine, Lateral, and Between Left and Right Positions During Two- and One-Lung Ventilation (OLV): Comparison of Hemodynamic Changes After Lung Recruitment Maneuver and Fluid Challenge Among Responders and Non-Responders (SVI, MAP, CPI Changes).

Hemodynamic Changes in Left and Right Lateral Position During One Lung Ventilation

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Maria Fountoulaki · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The aim of this trial is to study the changes of the Cardiac Power Index (CPI) during supine and lateral decubitus position in two and one lung ventilation respectively. Moreover, CPI variations will be compared among patients in left versus patients in right lateral decubitus position. A secondary goal is to compare the changes in hemodynamic parameters after a lung recruitment maneuver during one lung ventilation and a fluid challenge test among patients that respond (responders) or do not respond to fluids (non-responders) according to changes of Stroke Volume Index (SVI) and Mean Arterial Pressure (MAP).

Detailed description

This study investigates changes in Cardiac Power Index (CPI) in the same patients across different body positions (supine and lateral) during both two-lung ventilation (2LV) and one-lung ventilation (OLV). The primary aim is to assess how these positional and ventilation changes influence CPI values, a dynamic hemodynamic marker of cardiac function. A secondary objective is to evaluate the hemodynamic response to a recruitment maneuver and a fluid challenge, using stroke volume (SV) and mean arterial pressure (MAP) as indicators. All measurements are performed with the chest closed, prior to surgical incision. Patients will be placed under general anesthesia with thoracic epidural support, and continuous hemodynamic monitoring will be established via a radial artery catheter connected to a HemoSphere monitor (Edwards Lifesciences). Key parameters monitored include CPI, cardiac index (CI), heart rate (HR), stroke volume index (SVI), and MAP. Hemodynamic data will be collected at various predefined timepoints: 1. Baseline in the supine position under 2LV 2. Lateral position under OLV 3. Before and after a recruitment maneuver 4. Before and after a standardized fluid challenge The recruitment maneuver consists of continuous positive airway pressure at 30 cmH₂O for 30 seconds. The fluid challenge involves administering 250 mL of isotonic saline over 10 minutes. Hemodynamic responses will be used to classify patients as fluid responders or non-responders based on ≥10% changes in SV and/or MAP. Data analysis will focus on comparing CPI trends across positions and ventilation modes, as well as evaluating the utility of CPI in predicting fluid responsiveness. Hemodynamic parameters will be collected digitally and analyzed for intraoperative trends.

Conditions

• Thoracic Surgical Procedures
• One-lung Ventilation (OLV)
• Hemodynamic Changes

Interventions

Type	Name	Description
OTHER	Fluid challenge during one-lung ventilation (OLV) in the lateral decubitus position	During OLV, a lung recruitment maneuver will be performed, followed by measurements of CPI, CI, SVI, and MAP. A fluid challenge using 250 mL of normal saline (0.9% NaCl) will be administered. Hemodynamic parameters will be recorded at 2 and 5 minutes post-infusion. Patients will be classified as responders (SVI and MAP increase ≥10%) or non-responders. Changes in CPI will also be recorded accordingly.
DEVICE	Hemodynamic monitoring	Invasive hemodynamic monitoring will be performed using the HemoSphere device (Edwards Lifesciences).

Timeline

• Start date: 2025-05-06
• Primary completion: 2026-05-06
• Completion: 2027-05-06
• First posted: 2025-06-25
• Last updated: 2025-06-25

Locations

1 site across 1 country: Greece