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).

NCT07037225 | Active Not Recruiting

• 1 other identifier: 36032
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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).

Conditions

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

Keywords

Cardiac Power Index; Fluid Challenge; One-Lung Ventilation; Lateral Decubitus Position; Stroke Volume Index; Prone Position; Mean Arterial Pressure; Hemodynamic Monitoring

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• Change in Stroke Volume Index (SVI) in Response to Fluid Challenge

  up to 100 weeks

• Change in Mean Arterial Pressure (MAP) in Response to Fluid Challenge

  up to 100 weeks

• Change in Cardiac Power Index (CPI) in Response to Fluid Challenge

  up to 100 weeks

Study Arms (2)

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.

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

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.

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

Interventions

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.

Left Lateral Decubitus Position Group; Right Lateral Decubitus Position Group

Hemodynamic monitoring DEVICE

Invasive hemodynamic monitoring will be performed using the HemoSphere device (Edwards Lifesciences).

Left Lateral Decubitus Position Group; Right Lateral Decubitus Position Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Maria Fountoulaki: lead

Study Sites (1)

Attikon Hospital

Athens, Chaidari, 12462, Greece

Location

Related Publications (9)

• 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.

  PMID: 38813019 BACKGROUND

• 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.

  PMID: 11117920 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.

  PMID: 30349271 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.

  PMID: 33687175 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.

  PMID: 36294844 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.

  PMID: 39117065 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.

  PMID: 38929229 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.

  PMID: 37636561 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.

  PMID: 11792354 BACKGROUND

Related Links

• Physiology of the Lateral Decubitus Position, Open Chest, and One-Lung Ventilation
• Evidence-based thoracic epidural nerve block: A systematic review

MeSH Terms

Interventions

Hemodynamic Monitoring

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Monitoring, Physiologic

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Medical Doctor, Anesthesiology Resident

Study Record Dates

• First Submitted: May 21, 2025
• First Posted: June 25, 2025
• Study Start: May 6, 2025
• Primary Completion: May 6, 2026
• Study Completion (Estimated): May 6, 2027
• Last Updated: June 25, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share

Locations

GR (1)