Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06897514

External Validation of Prediction Algorithm Using Non-invasive Monitoring Device for Intraoperative Hypotension

The goal of this prospective observational study is to externally validate the prediction algorithm using non-invasive monitoring device for intraoperative hypotension. The main question it aims to answer is: Does the prediction algorithm predict intraoperative hypotension effectively?

Recruiting

Interested in participating?

Request Info

Key information

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

The hypotension that occurs during surgery is associated with the poor prognosis of patients after surgery. Previous studies have reported that even a short period of time of hypotension increases the risk of postoperative complications such as kidney injury. If anesthesiologists can predict intraoperative hypotension in advance, they can prevent or minimize the damage.

Recently, there are many reports on medical artificial intelligence models that predict the intraoperative hypotension. Among them, the Hypotension Prediction Index (HPI) model has already been commercialized and used in clinical practice. However, HPI has limitations in that it is necessary to perform invasive techniques (arterial cannulation) or to use dedicated equipment at high cost. However, since many of the general anesthesia are performed without invasive monitoring devices, the use of HPI medical devices is subject to considerable restrictions.

The investigators have reported the prediction algorithm for intraoperative hypotension using five non-invasive monitoring devices commonly used in general anesthesia: 1) blood pressure (NBP, number), 2) electrocardiogram (ECG, waveform), 3) end-oxygen saturation waveform (PPG, waveform), 4) end-stage carbon dioxide waveform (ETCO2, waveform), and 5) an anesthesia depth (BIS, number) By conducting a retrospective external validation process using public clinical data from other institutions (tertiary hospital in Korea), the final model was able to have good predictability with an Area Under the Receiver-Operating Characteristic Curve (AUROC) value of 0.917.

However, investigators did not externally validate that algorithm through a prospective designed study. This study intends to externally validate the "hypertension prediction model during surgery using non-invasive monitoring device", which has already reported It is expected that the usefulness and limitations of the prediction model can be evaluated again, and the model can be advanced based on the results.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults patients aged 19 or more
  • Elective surgery under general anesthesia
  • American Society of Anesthesiologists physical status I - III

Exclusion criteria

  • Vasopressor/Inotrope usage before surgery
  • Patients who needs invasive arterial cannulation
  • Emergency surgery
  • Pregnant or lactating women

Treatment and study plan

Prediction algorithm for intraoperative hypotension

Diagnostic Test

All participants will receive five non-invasive monitoring during their surgery. Data from these monitoring device will be put into the prediction algorithm.

Primary outcomes

  1. Value of the Area Under the Receiver-Operating Characteristic curve analysis

    Time frame: 5 minutes before the occurrence of hypotension during general anesthesia

    The area under the receiver operating characteristic curve is a measurement of how well a prediction model can predict intraoperative hypotension. It is used to assess the performance of algorithm.

Study contacts

Contact information is provided by the study sponsor or research team.

Hyun Joo Ahn, MD PhD

CONTACT

[email protected]

821099330784

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Mar 27, 2025
Registry last updated
May 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.