Actively Recruiting

Age: 18Years +
All Genders
ID06202638

An Observational, Prospective Multi-centre Study of the Hypotension Prediction Index (HPI) in Patients Undergoing Lung Resections Using One-Lung Ventilation

Led by John Paul II Hospital, Krakow · Updated on 2025-08-12

60

Participants Needed

3

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the Hypotension Prediction Index (HPI), an artificial intelligence-based algorithm designed to predict intraoperative hypotension (low blood pressure during surgery) by analyzing arterial pressure waveforms. This observational study aims to validate the HPI technology specifically in adult patients undergoing lung resection surgeries with one-lung ventilation, as this setting has unique physiological challenges that may affect the algorithm's accuracy. The study is prospective and multi-center, focusing on patients having thoracic surgeries such as lobectomies or pneumonectomies. During the surgical procedure, 60 adult patients will be monitored using standard invasive arterial pressure devices alongside the HemoSphere monitor equipped with the HPI software. The clinicians will not see the HPI readings to avoid bias. Data will be collected continuously from arterial cannula insertion until the end of surgery, covering seven distinct time periods reflecting different surgical and ventilation conditions, including closed chest with two-lung ventilation and open chest with one-lung ventilation. Participants will undergo routine monitoring during the operation, with hemodynamic waveforms and HPI prediction data recorded for analysis. Researchers will evaluate the HPI's ability to predict hypotensive episodes, focusing on its positive predictive value and event rate throughout the surgery. The study will follow STARD guidelines for accuracy and reporting, aiming to understand the HPI's performance in this specific surgical context without affecting patient care. Total participation is limited to the intraoperative period.

CONDITIONS

Brief Title

Hypotension Prediction Index (HPI) in Lung Resections

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults over 18 years old
  • 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
  • Planned overnight hospitalization
  • Scheduled for lung resection procedures such as video-assisted thoracoscopic (VATS) lobectomy, open-thoracotomy lobectomy, or pneumonectomy
Not Eligible

You will not qualify if you...

  • Urgent or emergency procedures
  • Known clinically important intracardiac shunts
  • Moderate to severe valvular heart disease
  • Preoperative symptomatic arrhythmias including atrial fibrillation
  • Congestive heart failure with left ventricular ejection fraction less than 35%
  • Refusal to participate in the study

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Implementation

Duration - Duration of the surgery and intraoperative period

Participants undergo lung resection surgery under general anesthesia with one-lung ventilation. During the operation, they are monitored using standard invasive arterial pressure monitoring and the HemoSphere monitor with the Hypotension Prediction Index software. Data including hemodynamic waveforms and hypotensive events are recorded from arterial cannula insertion until leaving the operating room.

1 intraoperative monitoring session

Surveillance

Duration - Intraoperative period

Participants are observed during the intraoperative period through continuous recording of hemodynamic data to assess the Hypotension Prediction Index performance in lung resection surgeries with one-lung ventilation.

Continuous monitoring during surgery

Trial Site Locations

Total: 3 locations

1

Faculty of Medicine, NKUA Attikon University Hospital

Athens, Greece, 12462

Not Yet Recruiting

2

St. John Paul II Hospital in Krakow

Krakow, Małopolska, Poland, 31-202

Actively Recruiting

3

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

Zabrze, Silesian Voivodeship, Poland, 40-055

Actively Recruiting

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Research Team

M

Mirosław Ziętkiewicz, MD, PhD

S

Szymon Białka, MD, PhD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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Published Research Related To This Trial

Ability of an Arterial Waveform Analysis-Derived Hypotension Prediction Index to Predict Future Hypotensive Events in Surgical Patients.

Simon James Davies, Simon Tilma Vistisen, Zhongping Jian...

https://pubmed.ncbi.nlm.nih.gov/30896602

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.

Ward H van der Ven, Lotte E Terwindt, Nurseda Risvanoglu...

https://pubmed.ncbi.nlm.nih.gov/34775533

Relationship between intraoperative mean arterial pressure and clinical outcomes after noncardiac surgery: toward an empirical definition of hypotension.

Michael Walsh, Philip J Devereaux, Amit X Garg...

https://pubmed.ncbi.nlm.nih.gov/23835589