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/Actively Recruiting
Led by John Paul II Hospital, Krakow · Updated on 2025-08-12
60
Participants Needed
3
Research Sites
N/A
Total Duration
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 algorithms 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 HPIs 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 HPIs performance in this specific surgical context without affecting patient care. Total participation is limited to the intraoperative period.
CONDITIONS
Hypotension Prediction Index (HPI) in Lung Resections
M
Mirosław Ziętkiewicz, MD, PhD
S
Szymon Białka, MD, PhD
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John Paul II Hospital, Krakow
Lead Sponsor
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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
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
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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Lead Sponsor