Hypotension Prediction Index (HPI) in Lung Resections

NCT06202638 | Recruiting

• 1 other identifier: NB.060.1.011.2022
• Study Type: observational
• Target: 60
• Locations: 2 countries
• Sites: 3

Brief 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. 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.

Conditions

Intraoperative Hypotension

Keywords

Hypotension; One Lung Ventilation; Intelligence; Artificial

Outcome Measures

Primary Outcomes (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)

  Intraoperative period

Secondary Outcomes (1)

• Event rate

  Intraoperative period

Study Arms (1)

The arterial pressure and HPI course in 7 time-windows cohorts in one-lung ventilated patients

60 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.

Device: HemoSphere monitor with Acumen Hypotension Prediction Index Software

Interventions

HemoSphere monitor with Acumen Hypotension Prediction Index Software DEVICE

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

The arterial pressure and HPI course in 7 time-windows cohorts in one-lung ventilated patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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).

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• John Paul II Hospital, Krakow: lead

Study Sites (3)

Faculty of Medicine, NKUA Attikon University Hospital

Athens, 12462, Greece

NOT YET RECRUITING

St. John Paul II Hospital in Krakow

Krakow, Małopolska, 31-202, Poland

RECRUITING

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

Zabrze, Silesian Voivodeship, 40-055, Poland

RECRUITING

Related Publications (28)

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MeSH Terms

Conditions

Hypotension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Mirosław Ziętkiewicz, MD, PhD

  2nd Anesthesiology and Intensive Care Unit, John Paul II Hospital, Prądnicka St. 80, Kraków, Poland

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mirosław Ziętkiewicz, MD, PhD

CONTACT

+48 609 668 145; mjzietkiewicz@gmail.com

Szymon Białka, MD, PhD

CONTACT

+48 606 493 210; szymon.bialka@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator; Head of the Anesthesia and Intensive Care Unit

Study Record Dates

• First Submitted: January 1, 2024
• First Posted: January 11, 2024
• Study Start: November 11, 2023
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: August 12, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1); PL (2)