Thoracic Surgical ProceduresNCT07037225

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).

A study testing Fluid challenge during one-lung ventilation (OLV) in the lateral decubitus position and Hemodynamic monitoring in people with Thoracic Surgical Procedures and One-lung Ventilation (OLV), run by Maria Fountoulaki at 1 site in Greece.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Thoracic Surgical Procedures, One-lung Ventilation (OLV), Hemodynamic Changes
What is being tested?: Fluid challenge during one-lung ventilation (OLV) in the lateral decubitus position and Hemodynamic monitoring
Type of treatment: Injection or infusion, Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 60 participants
Where: 1 siteGreece
Study dates: 6 May 2025to 6 May 2027
Phase: Interventional
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Who cannot join

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 locations and contacts

1 site in 1 country.

Greece1 site

Attikon Hospital
Athens, Chaidari, 12462

Other trials in Greece

About this study

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

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).

Read the 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:

Baseline in the supine position under 2LV
Lateral position under OLV
Before and after a recruitment maneuver
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.

Conditions: Thoracic Surgical Procedures, One-lung Ventilation (OLV), Hemodynamic Changes
Being tested: Fluid challenge during one-lung ventilation (OLV) in the lateral decubitus position, Hemodynamic monitoring
Keywords: Cardiac Power Index, Fluid Challenge, One-Lung Ventilation, Lateral Decubitus Position, Stroke Volume Index, Prone Position, Mean Arterial Pressure, Hemodynamic Monitoring

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Fluid challenge during one-lung ventilation (OLV) in the lateral decubitus positionOther
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.
Hemodynamic monitoringDevice
Invasive hemodynamic monitoring will be performed using the HemoSphere device (Edwards Lifesciences).

Study groups in NCT07037225
Study group	Role	What they receive
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. Receives: 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. Receives: Other: Fluid challenge during one-lung ventilation (OLV) in the lateral decubitus position; Device: Hemodynamic monitoring

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: up to 100 weeks

Secondary outcomes (3)

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
Measured: up to 100 weeks
Change in Mean Arterial Pressure (MAP) in Response to Fluid Challenge
MAP will be measured in response to fluid challenge during one-lung ventilation.
Unit of Measure: mmHg
Measured: 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
Measured: up to 100 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

6 May 20256 May 2027

First posted25 Jun 2025
Study start6 May 2025
Primary completion6 May 2026 (estimated)
Study completion6 May 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (9)Papers the sponsor has linked to this study.
Other trials for Thoracic Surgical ProceduresStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 60 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07037225
Sponsor's protocol ID: 36032
Status last verified: Jun 2025
First submitted: 21 May 2025
Last updated: 25 Jun 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: All collected IPD

Publications

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.
PubMed 38813019
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.
PubMed 11117920
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.
PubMed 30349271
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.
PubMed 33687175
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.
PubMed 36294844
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.
PubMed 39117065
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.
PubMed 38929229
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.
PubMed 37636561
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.
PubMed 11792354

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 25 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Hemodynamic Changes in Left and Right Lateral Position During One Lung Ventilation
ClinicalTrials.gov ID: NCT07037225
Acronym / sponsor ID: 36032
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
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 60 participants (estimated)
Lead sponsor: Maria FountoulakiUniversity, hospital or other
Study start: 6 May 2025 (actual)
Primary completion: 6 May 2026 (estimated)
Study completion: 6 May 2027 (estimated)
First posted: 25 Jun 2025 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Hemodynamic data will be collected at various predefined timepoints:

Baseline in the supine position under 2LV
Lateral position under OLV
Before and after a recruitment maneuver
Before and after a standardized fluid challenge

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Right Lateral Decubitus Position Group	Active comparator	Other: Fluid challenge during one-lung ventilation (OLV) in the lateral decubitus position, Device: Hemodynamic monitoringCardiac 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	Other: Fluid challenge during one-lung ventilation (OLV) in the lateral decubitus position, Device: Hemodynamic monitoringCardiac 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (6 listed)

Known arrhythmia
Severe valvular disease
Severe right or left ventricular dysfunction
Morbid obesity (BMI ≥ 40 kg/m²)
Inability to perform spirometry and/or echocardiography

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Fluid challenge during one-lung ventilation (OLV) in the lateral decubitus positionDuring 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.	Other	Left Lateral Decubitus Position Group, Right Lateral Decubitus Position Group
Hemodynamic monitoringInvasive hemodynamic monitoring will be performed using the HemoSphere device (Edwards Lifesciences).	Device	Left Lateral Decubitus Position Group, Right Lateral Decubitus Position Group

Primary outcome

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

3 secondary outcomes

Change in Stroke Volume Index (SVI) in Response to Fluid Challenge
Time frame: up to 100 weeks
Change in Mean Arterial Pressure (MAP) in Response to Fluid Challenge
Time frame: up to 100 weeks
Change in Cardiac Power Index (CPI) in Response to Fluid Challenge
Time frame: up to 100 weeks

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2025.
Background: PubMed 38813019Abdullah 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.
Background: PubMed 11117920Fujita 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.
Background: PubMed 30349271Jiang 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.
Background: PubMed 33687175Kimura 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.
Background: PubMed 36294844Nisi 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.
Background: PubMed 39117065Min 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.
Background: PubMed 38929229Liu 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.
Background: PubMed 37636561Zhang 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.
Background: PubMed 11792354Miyamoto 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.
Physiology of the Lateral Decubitus Position, Open Chest, and One-Lung VentilationLink provided by the sponsor.
Evidence-based thoracic epidural nerve block: A systematic reviewLink provided by the sponsor.
Individual participant dataSharing planned: Yes. All collected IPD

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 25 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Cardiac Power Index (CPI) Across Body Positions (time frame: up to 100 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07037225, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2025.