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).

Maria Fountoulaki

Status: Active, not recruiting

Conditions: One-lung Ventilation (OLV); Thoracic Surgical Procedures; Hemodynamic Changes

Treatments: Device: Hemodynamic monitoring; Other: Fluid challenge during one-lung ventilation (OLV) in the lateral decubitus position

Study type: Interventional

Funder types: Other

Identifiers

NCT07037225

36032

Details and patient eligibility

About

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).

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Right Lateral Decubitus Position Group

Active Comparator group

Description:

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.

Treatment:

Other: Fluid challenge during one-lung ventilation (OLV) in the lateral decubitus position

Device: Hemodynamic monitoring

Left Lateral Decubitus Position Group

Active Comparator group

Description:

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.

Treatment:

Other: Fluid challenge during one-lung ventilation (OLV) in the lateral decubitus position

Device: Hemodynamic monitoring