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Intraoperative HypotensionNCT06202638

Hypotension Prediction Index (HPI) in Lung Resections

An observational study of Intraoperative Hypotension, run by John Paul II Hospital, Krakow at 3 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Perioperative hypotension is a risk factor for perioperative complications. Advances in machine learning and artificial intelligence have produced an algorithm that predicts the occurrence of hypotension episodes by analyzing an arterial pressure waveform. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Intraoperative Hypotension
What is being tested?
HemoSphere monitor with Acumen Hypotension Prediction Index Software
Type of treatment
Medical device
How many people
77 participants
Where
3 sitesin 2 countries
Study dates
11 Nov 2023to 31 Dec 2025
How long will I take part?
1 Day
Phase
Observational
Are there results?
None posted in the registry

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
  • No healthy volunteers
  • Adult, Older adult

Study population: 60 consecutive adult patients qualified for open-chest lung resection procedures under general anesthesia and one-lung ventilation will be monitored during the operation using standard invasive hemodynamic monitoring with arterial pressure transducer and concomitantly with HemoSphere monitor with the HPI software attached to the Acumen IQ transducer (Edwards LifeSciences, Irvine, CA, USA).

Who may be able to join

  • American Society of Anesthesiologists (ASA) physical status II to IV;
  • Planned invasive blood pressure monitoring during general anesthesia expected to last more than 2 hours and planned overnight hospitalization.
  • Procedures: video-assist thoracoscopic (VATS)-lobectomy, open-thoracotomy lobectomy, pneumonectomy.
  • Adults over 18 years old.

Who cannot join

  • Urgent/emergency procedures.
  • Patients with known clinically important intracardiac shunts.
  • Moderate to severe valvular disease.
  • Preoperative symptomatic arrhythmias including AF.
  • Congestive heart failure with LV ejection fraction less than 35%.
  • Refusal of participation

Trial locations and contacts

3 sites in 2 countries.

3 sites in 2 countries

Poland2 sites
  • St. John Paul II Hospital in Krakow

    Krakow, Małopolska, 31-202

  • Department of Anesthesiology and Intensive Therapy; Department of Pain Research and Treatment, Faculty of Medical Sciences Zabrze

    Zabrze, Silesian Voivodeship, 40-055

Other trials in Poland

Greece1 site
  • Faculty of Medicine, NKUA Attikon University Hospital

    Athens, 12462

Other trials in Greece

About this study

Official title: An Observational, Prospective, Non-randomized Multi-centre Cohort Feasibility Study of the Hypotension Prediction Index (HPI) in Patients Undergoing Lung Resections With the Use of One-lung Ventilation.

Perioperative hypotension is a risk factor for perioperative complications. Advances in machine learning and artificial intelligence have produced an algorithm that predicts the occurrence of hypotension episodes by analyzing an arterial pressure waveform. This technology has not been validated in thoracic surgical patients undergoing lung resections with the use of one-lung ventilation (OLV). We planned an observational, prospective multi-centre cohort validation study of the Hypotension Prediction Index (HPI) in patients undergoing lung resection procedures with the use of one-lung ventilation and a lung-protective strategy.

Read the detailed description

The Hypotension Prediction Index (HPI) is a hemodynamic score designed specifically for prediction of the intraoperative hypotension (IOH) episodes. It is based on an algorithm programmed into Edwards Lifesciences HemoSphere monitor clinical platform (Irvine, CA, USA). The HPI is based on a continuous analysis of an arterial pressure waveform. It is processed in addition to the FloTrac algorithm via proprietary Acumen IQ Sensor and uses an artificial intelligence technology. After internal validation, the algorithm was prospectively, externally and clinically validated in general surgical, perioperative patients, cardiovascular surgical patients, and mechanically ventilated COVID-19 ICU patients.

As opposed to conventional monitoring systems, which display physiological parameters in real life, an HPI algorithm detects the earliest changes, multivariate variability and interactions in the physiologic inter-related data on preload, afterload, and contractility to deliver an index predicting an upcoming hypotensive event. Variables used by the patent-protected algorithm to calculate HPI are as follows: heart rate variability (changes in heart rate/changes in MAP); arterial pressure waveform complexity (approximate waveform entropy, sample waveform entropy, frequency domain measure of higher order harmonics); preload parameters (pulse pressure variation PPV, stroke volume variation SVV); contractility parameters (slope of the ascending part of the pressure waveform above time, dP/dt); and afterload parameters (SVR, dynamic arterial elastance Eadyn), but their relative contribution to final index is not revealed.

Final index values of HPI range from 1 to 100, with increasing numbers representing a greater likelihood of an impending hypotensive event. These events are defined as mean arterial pressure (MAP) <65 mmHg occurring for over one minute. HPI values predict the occurrence of hypotension five to fifteen minutes before the event, with sensitivity and specificity in both time-frames of greater than 80%. In most studies, a value of 85 HPI predicts a hypotensive episode, and this value is arbitrarily preprogrammed into the HemoSphere monitor to alert the clinician and allow proactive responses to minimize or even entirely prevent intraoperative hypotension.

Parameters used and incorporated into the HemoSphere monitor can guide a clinician in the optimal management of IOH. These "secondary screen" variables include the left ventricular contractility parameter (dP/dt), dynamic preload parameter (SVV) and afterload parameter dynamic arterial elastance Eadyn.

Maximal left ventricular (LV) pressure rise (LV dP/dt max) is a classical marker of LV performance and systolic function. It is conventionally defined as the change in pressure in the left ventricular cavity over the isovolumetric contraction period and it originally requires LV catheterization. In clinical practice a surrogate peripheral arterial pressure waveform is used to estimate dP/dt value and to predict the need for inotropic support.

SVV is a dynamic preload parameter and represents the difference in the left ventricular stroke volume secondary to changes in intrathoracic pressure induced by mechanical ventilation.

The dynamic arterial elastance Eadyn represents the proportion of pulse-pressure variation (PPV) to SVV. It can be used to assess vascular tone, which can predict arterial pressure response after volume loading and/or potential response to vasopressor administration.

Both PPV and SVV are considered superior to static indices to predict fluid responsiveness. They are both based on heart-lung interactions and reflect hemodynamic cyclic changes induced by mechanical ventilation in the closed-chest condition. Their values are significantly correlated with the magnitude of VT. The current low-tidal volume intraoperative ventilatory strategy protects the lungs, but at the same time lowers the reliability of dynamic indices, particularly in open-chest conditions. Due to limited changes in intrathoracic pressure during the respiratory cycle in open lung conditions, there is a risk of receiving false negative parameter values. PPV and SVV seem to be inaccurate in predicting fluid responsiveness in an open-chest setting during cardiothoracic surgery.

The HPI was validated in general surgery and ICU cases, but not in thoracic surgery one-sided open chest procedures. These procedures include not only significantly abnormal physiologic conditions (open pleura and one-lung protective ventilation) but also a high incidence of sudden manual surgical interventions. All these factors can significantly influence and compromise the HPI performance.

The aim of this study is to validate the HPI technology in open-chest lung resection procedures with the use of one-lung ventilation. The study group will comprise 60 consecutive adult patients qualified for lung resection procedures under general anesthesia with open-chest and one-lung ventilation.

The patients will be monitored during the operation using standard invasive hemodynamic monitoring with arterial pressure transducer and concomitantly with HemoSphere monitor with the HPI software attached to the Acumen IQ transducer (Edwards LifeSciences, Irvine, CA, USA). The clinicians will be blinded to the output of the HemoSphere monitor. Hemodynamic waveforms and HPI prediction data including hypotensive events (IOH) will be recorded from the time of arterial cannula insertion until leaving the operation room. Recorded data will be divided into seven cohorts, represented by separate time frames:

  1. Pre-induction baseline, supine, spontaneous breathing (if available and arterial cannula inserted pre-induction)
  2. Supine, closed-chest anaesthetized, intubated, two-lung ventilation
  3. Lateral decubitus, closed chest, two-lung ventilation
  4. Lateral decubitus, closed chest, one-lung ventilation (OLV)
  5. Lateral decubitus, open chest, one-lung ventilation (OLV)
  6. Lateral decubitus, closed chest, two-lung ventilation post-resection
  7. Supine, closed-chest, two-lung ventilation

We will estimate the sensitivity (recall) and positive predictive value (precision) of the HPI algorithm and describe the number of false alarms as well as missed events without explicitly referring to specificity or negative predictive value.

Study conduct and reporting will be performed under the STARD guidelines.

Being tested
HemoSphere monitor with Acumen Hypotension Prediction Index Software
Keywords
Hypotension, One Lung Ventilation, Intelligence, Artificial
Medical subject headings
Hypotension

What participants receive

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

  • HemoSphere monitor with Acumen Hypotension Prediction Index SoftwareDevice

    Two concomitant courses of intraoperative data will be recorded: 1. the arterial waveform and pressure on the standard hemodynamic patient monitor and 2. the data from the HemoSphere monitor with Acumen Hypotension Prediction Index Software

Study groups in NCT06202638
Study groupRoleWhat they receive
The arterial pressure and HPI course in 7 time-windows cohorts in one-lung ventilated patients60 consecutive adult patients qualified for open-chest lung resection procedures under general anesthesia with one-lung ventilation will be monitored during the operation using standard invasive hemodynamic monitoring with arterial pressure transducer and concomitantly with HemoSphere monitor with the HPI software attached to the Acumen IQ transducer (Edwards LifeSciences, Irvine, CA, USA). The clinicians will be blinded to the output of the HemoSphere monitor. Hemodynamic waveforms and HPI prediction data will be recorded from the time of arterial cannula insertion until leaving the operation room. HPI values and intraoperative hemodynamic course including intraoperative hypotensive events (IOH) will be recorded at all stages of the procedure.
Receives: Device: HemoSphere monitor with Acumen Hypotension Prediction Index Software

What is being measured

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

  1. Positive predictive value

    • Positive predictive value (precision) of the Hypotension Prediction Index (HPI) algorithm (95% CI) for prediction of IOH episodes at different time intervals (5, 10, 15 minutes) in lung resection surgery patients
    • Sensitivity (recall) of the Hypotension Prediction Index (HPI) algorithm (95% CI) for prediction of IOH episodes at different time intervals (5, 10, 15 minutes) in lung resection surgery patients.
    • Calibration curve (incidence of IOH vs. HPI; 95% CI)

    Measured: Intraoperative period

Secondary outcomes (1)
  1. Event rate

    • Event rate across the observed spectrum of HPI values - i.e. the number of false alarms as well as missed events without explicitly referring to specificity or negative predictive value.
    • Average values of dynamic preload parameters PPV, SVV and arterial elastance and their change during OLV.

    Measured: Intraoperative period

Timeline

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

  1. First posted11 Jan 2024
  2. Study start11 Nov 2023
  3. Primary completion31 Dec 2025
  4. Study completion31 Dec 2025

Resources

More details

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

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
77 participants (actual)
Target duration
1 Day
IDs, dates and publications
ClinicalTrials.gov ID
NCT06202638
Sponsor's protocol ID
NB.060.1.011.2022
Status last verified
Sep 2026
First submitted
1 Jan 2024
Last updated
16 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Hatib F, Jian Z, Buddi S, Lee C, Settels J, Sibert K, Rinehart J, Cannesson M. Machine-learning Algorithm to Predict Hypotension Based on High-fidelity Arterial Pressure Waveform Analysis. Anesthesiology. 2018 Oct;129(4):663-674. doi: 10.1097/ALN.0000000000002300.

    PubMed 29894315
  • de Keijzer IN, Vos JJ, Scheeren TWL. Hypotension Prediction Index: from proof-of-concept to proof-of-feasibility. J Clin Monit Comput. 2020 Dec;34(6):1135-1138. doi: 10.1007/s10877-020-00465-3. Epub 2020 Jan 23. No abstract available.

    PubMed 31974829
  • Rajkomar A, Dean J, Kohane I. Machine Learning in Medicine. N Engl J Med. 2019 Apr 4;380(14):1347-1358. doi: 10.1056/NEJMra1814259. No abstract available.

    PubMed 30943338
  • Davies SJ, Vistisen ST, Jian Z, Hatib F, Scheeren TWL. Ability of an Arterial Waveform Analysis-Derived Hypotension Prediction Index to Predict Future Hypotensive Events in Surgical Patients. Anesth Analg. 2020 Feb;130(2):352-359. doi: 10.1213/ANE.0000000000004121.

    PubMed 30896602
  • Shin B, Maler SA, Reddy K, Fleming NW. Use of the Hypotension Prediction Index During Cardiac Surgery. J Cardiothorac Vasc Anesth. 2021 Jun;35(6):1769-1775. doi: 10.1053/j.jvca.2020.12.025. Epub 2020 Dec 21.

    PubMed 33446404
  • van der Ven WH, Terwindt LE, Risvanoglu N, Ie ELK, Wijnberge M, Veelo DP, Geerts BF, Vlaar APJ, van der Ster BJP. Performance of a machine-learning algorithm to predict hypotension in mechanically ventilated patients with COVID-19 admitted to the intensive care unit: a cohort study. J Clin Monit Comput. 2022 Oct;36(5):1397-1405. doi: 10.1007/s10877-021-00778-x. Epub 2021 Nov 13.

    PubMed 34775533
  • Vistisen ST, Johnson AEW, Scheeren TWL. Predicting vital sign deterioration with artificial intelligence or machine learning. J Clin Monit Comput. 2019 Dec;33(6):949-951. doi: 10.1007/s10877-019-00343-7. Epub 2019 Jun 28. No abstract available.

    PubMed 31254239
  • Walsh M, Devereaux PJ, Garg AX, Kurz A, Turan A, Rodseth RN, Cywinski J, Thabane L, Sessler DI. Relationship between intraoperative mean arterial pressure and clinical outcomes after noncardiac surgery: toward an empirical definition of hypotension. Anesthesiology. 2013 Sep;119(3):507-15. doi: 10.1097/ALN.0b013e3182a10e26.

    PubMed 23835589
  • Vos JJ, Scheeren TWL. Intraoperative hypotension and its prediction. Indian J Anaesth. 2019 Nov;63(11):877-885. doi: 10.4103/ija.IJA_624_19. Epub 2019 Nov 8.

    PubMed 31772395
  • Sharman JE, Qasem AM, Hanekom L, Gill DS, Lim R, Marwick TH. Radial pressure waveform dP/dt max is a poor indicator of left ventricular systolic function. Eur J Clin Invest. 2007 Apr;37(4):276-81. doi: 10.1111/j.1365-2362.2007.01784.x.

    PubMed 17373963
  • de Waal EE, Rex S, Kruitwagen CL, Kalkman CJ, Buhre WF. Dynamic preload indicators fail to predict fluid responsiveness in open-chest conditions. Crit Care Med. 2009 Feb;37(2):510-5. doi: 10.1097/CCM.0b013e3181958bf7.

    PubMed 19114886
  • Piccioni F, Bernasconi F, Tramontano GTA, Langer M. A systematic review of pulse pressure variation and stroke volume variation to predict fluid responsiveness during cardiac and thoracic surgery. J Clin Monit Comput. 2017 Aug;31(4):677-684. doi: 10.1007/s10877-016-9898-5. Epub 2016 Jun 15.

    PubMed 27306799
  • Fu Q, Duan M, Zhao F, Mi W. Evaluation of stroke volume variation and pulse pressure variation as predictors of fluid responsiveness in patients undergoing protective one-lung ventilation. Drug Discov Ther. 2015 Aug;9(4):296-302. doi: 10.5582/ddt.2015.01046.

    PubMed 26370528
  • Tugrul M, Camci E, Karadeniz H, Senturk M, Pembeci K, Akpir K. Comparison of volume controlled with pressure controlled ventilation during one-lung anaesthesia. Br J Anaesth. 1997 Sep;79(3):306-10. doi: 10.1093/bja/79.3.306.

    PubMed 9389846
  • Montes FR, Pardo DF, Charris H, Tellez LJ, Garzon JC, Osorio C. Comparison of two protective lung ventilatory regimes on oxygenation during one-lung ventilation: a randomized controlled trial. J Cardiothorac Surg. 2010 Nov 2;5:99. doi: 10.1186/1749-8090-5-99.

    PubMed 21044330

Questions about this trial

What is this clinical trial studying?

An observational study of Intraoperative Hypotension, run by John Paul II Hospital, Krakow at 3 sites in 2 countries.

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: finished, as of the sponsor's last update on 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Poland, 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Positive predictive value (time frame: Intraoperative period). 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 NCT06202638, which also lists 28 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 16 Sep 2026.

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