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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Right Lateral Decubitus Position Group | Active Comparator | 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. |
|
| Left Lateral Decubitus Position Group | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluid challenge during one-lung ventilation (OLV) in the lateral decubitus position | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | up to 100 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | up to 100 weeks |
| Change in Mean Arterial Pressure (MAP) in Response to Fluid Challenge |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Attikon Hospital | Athens | Chaidari | 12462 | Greece |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38813019 | Background | Abdullah T, Gokduman HC, Eniste IA, Atasever AG, Ali A, Gumus Ozcan F. Novel parameters for predicting fluid responsiveness during the mini fluid challenge and ability of the cardiac power index: an observational cohort study. Turk J Med Sci. 2023 Aug 26;53(5):1224-1233. doi: 10.55730/1300-0144.5688. eCollection 2023. | |
| 11117920 |
| Label | URL |
|---|---|
| Physiology of the Lateral Decubitus Position, Open Chest, and One-Lung Ventilation | View source |
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All collected IPD
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 1, 2025 |
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|
| Hemodynamic monitoring | Device | Invasive hemodynamic monitoring will be performed using the HemoSphere device (Edwards Lifesciences). |
|
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 | 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 |
| Fujita M, Miyamoto S, Sekiguchi H, Eiho S, Sasayama S. Effects of posture on sympathetic nervous modulation in patients with chronic heart failure. Lancet. 2000 Nov 25;356(9244):1822-3. doi: 10.1016/S0140-6736(00)03240-2. |
| 30349271 | Background | Jiang JS, Kor CT, Kuo DD, Lin CH, Chang CC, Chen GY, Kuo CD. Residual heart rate variability measures can better differentiate patients with acute myocardial infarction from patients with patent coronary artery. Ther Clin Risk Manag. 2018 Oct 8;14:1923-1931. doi: 10.2147/TCRM.S178734. eCollection 2018. |
| 33687175 | Background | Kimura A, Suehiro K, Juri T, Fujimoto Y, Yoshida H, Tanaka K, Mori T, Nishikawa K. Hemodynamic Changes via the Lung Recruitment Maneuver Can Predict Fluid Responsiveness in Stroke Volume and Arterial Pressure During One-Lung Ventilation. Anesth Analg. 2021 Jul 1;133(1):44-52. doi: 10.1213/ANE.0000000000005375. |
| 36294844 | Background | Nisi F, Giustiniano E, Meco M, Pugliese L, Calabro L, Spano S, Ripani U, Cecconi M. The Cardiac Power Index during Abdominal Open Aortic Surgery: Intraoperative Insights into the Cardiac Performance-A Retrospective Observational Analysis. J Pers Med. 2022 Oct 12;12(10):1705. doi: 10.3390/jpm12101705. |
| 39117065 | Background | Min JY, Jeon JP, Chung MY, Kim CJ. Use of the cardiac power index to predict fluid responsiveness in the prone position: a proof-of-concept study. Braz J Anesthesiol. 2024 Nov-Dec;74(6):844545. doi: 10.1016/j.bjane.2024.844545. Epub 2024 Aug 6. |
| 38929229 | Background | Liu T, He P, Hu J, Wang Y, Shen Y, Peng Z, Sun Y. The Hemodynamic Changes Induced by Lung Recruitment Maneuver to Predict Fluid Responsiveness in Children during One Lung Ventilation-A Prospective Observational Study. Children (Basel). 2024 May 27;11(6):649. doi: 10.3390/children11060649. |
| 37636561 | Background | Zhang Y, Ding Y, Zhang J, Huang T, Gao J. Tidal volume challenge-induced hemodynamic changes can predict fluid responsiveness during one-lung ventilation: an observational study. Front Med (Lausanne). 2023 Aug 9;10:1169912. doi: 10.3389/fmed.2023.1169912. eCollection 2023. |
| 11792354 | Background | Miyamoto S, Tambara K, Tamaki Si, Nagaya N, Hasegawa K, Nohara R, Miwa K, Fujita M. Effects of right lateral decubitus position on plasma norepinephrine and plasma atrial natriuretic peptide levels in patients with chronic congestive heart failure. Am J Cardiol. 2002 Jan 15;89(2):240-2. doi: 10.1016/s0002-9149(01)02212-3. No abstract available. |
| Evidence-based thoracic epidural nerve block: A systematic review | View source |
| Jun 11, 2025 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 1, 2025 | Jun 11, 2025 | ICF_001.pdf |
| ID | Term |
|---|---|
| D000074743 | Hemodynamic Monitoring |
| ID | Term |
|---|---|
| D003935 | Diagnostic Techniques, Cardiovascular |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D008991 | Monitoring, Physiologic |
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