Hemodynamic Changes, One-lung Ventilation (OLV), Thoracic Surgical Procedures
Conditions
Keywords
Cardiac Power Index, Fluid Challenge, One-Lung Ventilation, Lateral Decubitus Position, Stroke Volume Index, Prone Position, Mean Arterial Pressure, Hemodynamic Monitoring
Brief 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.
Interventions
OTHERFluid 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.
DEVICEHemodynamic monitoring
Invasive hemodynamic monitoring will be performed using the HemoSphere device (Edwards Lifesciences).
Sponsors
Maria Fountoulaki
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Age over 18 * Physical status ASA I-III (per the American Society of Anesthesiologists) * Fluent in Greek or English * Scheduled for thoracic surgery using a double-lumen endotracheal tube
Exclusion criteria
* Known arrhythmia * Severe valvular disease * Severe right or left ventricular dysfunction * Morbid obesity (BMI ≥ 40 kg/m²) * Inability to perform spirometry and/or echocardiography * Patient refusal to participate
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Cardiac Power Index (CPI) Across Body Positions | up to 100 weeks | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Stroke Volume Index (SVI) in Response to Fluid Challenge | up to 100 weeks | SVI will be assessed after a fluid challenge during one-lung ventilation to evaluate responsiveness to fluid administration. Unit of Measure: mL/m² |
| Change in Mean Arterial Pressure (MAP) in Response to Fluid Challenge | up to 100 weeks | MAP will be measured in response to fluid challenge during one-lung ventilation. Unit of Measure: mmHg |
| Change in Cardiac Power Index (CPI) in Response to Fluid Challenge | up to 100 weeks | 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 |
Countries
Greece
Outcome results
None listed