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).

June 21, 2025 updated by: Maria Fountoulaki

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

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).

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
    • Chaidari
      • Athens, Chaidari, Greece, 12462
        • Attikon Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Right Lateral Decubitus Position Group
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
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).
Active Comparator: Left Lateral Decubitus Position Group
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
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Cardiac Power Index (CPI) Across Body Positions
Time Frame: 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
up to 100 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Stroke Volume Index (SVI) in Response to Fluid Challenge
Time Frame: 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
up to 100 weeks
Change in Mean Arterial Pressure (MAP) in Response to Fluid Challenge
Time Frame: up to 100 weeks

MAP will be measured in response to fluid challenge during one-lung ventilation.

Unit of Measure: mmHg
up to 100 weeks
Change in Cardiac Power Index (CPI) in Response to Fluid Challenge
Time Frame: 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
up to 100 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maria Fountoulaki

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 6, 2025

Primary Completion (Estimated)

May 6, 2026

Study Completion (Estimated)

May 6, 2027

Study Registration Dates

First Submitted

May 21, 2025

First Submitted That Met QC Criteria

June 21, 2025

First Posted (Estimated)

June 25, 2025

Study Record Updates

Last Update Posted (Estimated)

June 25, 2025

Last Update Submitted That Met QC Criteria

June 21, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 36032

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All collected IPD

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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