An interventional study of Fluid challenge during one-lung ventilation (OLV) in the lateral decubitus position and Hemodynamic monitoring in Thoracic Surgical Procedures, One-lung Ventilation (OLV) and Hemodynamic Changes, sponsored by Maria Fountoulaki. Active, not recruiting at 1 site in Greece. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-06-25.
Sponsored by Maria Fountoulaki · Not applicable, Interventional, and Treatment
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).
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:
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.
This is the only study on the registry with Maria Fountoulaki as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Cardiac Power Index (CPI) baseline will be measured before induction of general anesthesia, then in the supine position during two-lung ventilation (2LV), and in the right lateral decubitus position during one-lung ventilation (OLV). Measurements will be compared across different positions within the same patient. Hemodynamic monitoring will be performed using the HemoSphere device. During OLV, a lung recruitment maneuver will be performed, followed by a fluid challenge using 250 mL of normal saline (0.9% NaCl). Hemodynamic parameters (CPI, Cardiac Index, Stroke Volume Index, and Mean Arterial Pressure) 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 monitored.
Other: Fluid challenge during one-lung ventilation (OLV) in the lateral decubitus position · Device: Hemodynamic monitoring
Cardiac Power Index (CPI) baseline will be measured before induction of general anesthesia, then in the supine position during two-lung ventilation (2LV), and in the left lateral decubitus position during one-lung ventilation (OLV). Measurements will be compared across different positions within the same patient. Hemodynamic monitoring will be performed using the HemoSphere device. During OLV, a lung recruitment maneuver will be performed, followed by a fluid challenge using 250 mL of normal saline (0.9% NaCl). Hemodynamic parameters (CPI, Cardiac Index, Stroke Volume Index, and Mean Arterial Pressure) 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 monitored.
Other: Fluid challenge during one-lung ventilation (OLV) in the lateral decubitus position · Device: Hemodynamic monitoring
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.
Invasive hemodynamic monitoring will be performed using the HemoSphere device (Edwards Lifesciences).
Change in Cardiac Power Index (CPI) Across Body Positions
Cardiac Power Index (CPI) will be measured in left, right and su pine positions to evaluate hemodynamic changes. CPI is calculated as (MAP × CO)/451 and indexed to body surface area. Unit of Measure: Watts/m²
Time frame: up to 100 weeks
Change in Stroke Volume Index (SVI) in Response to Fluid Challenge
SVI will be assessed after a fluid challenge during one-lung ventilation to evaluate responsiveness to fluid administration. Unit of Measure: mL/m²
Time frame: up to 100 weeks
Change in Mean Arterial Pressure (MAP) in Response to Fluid Challenge
MAP will be measured in response to fluid challenge during one-lung ventilation. Unit of Measure: mmHg
Time frame: up to 100 weeks
Change in Cardiac Power Index (CPI) in Response to Fluid Challenge
CPI will be monitored alongside SVI and MAP following fluid administration during one-lung ventilation to detect analogous hemodynamic changes. Unit of Measure: Watts/m²
Time frame: up to 100 weeks
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — All collected IPD
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