NCT05762237

Brief Summary

The investigators aimed to investigate the deep learning model to predict intraoperative hypotension using non-invasive monitoring parameters.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5,175

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 13, 2023

Completed
24 days until next milestone

First Posted

Study publicly available on registry

March 9, 2023

Completed
23 days until next milestone

Study Start

First participant enrolled

April 1, 2023

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2024

Completed
Last Updated

March 30, 2025

Status Verified

May 1, 2024

Enrollment Period

1.1 years

First QC Date

February 13, 2023

Last Update Submit

March 25, 2025

Conditions

Keywords

intraoperative hypotensionnoninvasive monitordeep learning algorithm

Outcome Measures

Primary Outcomes (1)

  • Deep learning model's prediction ability on intraoperative hypotension event

    Area under the curve the receiver operating characteristic (AUROC) curve for the deep learning model to predict intraoperative hypotension.

    through study completion, an average of 3 hour

Study Arms (1)

Group

In the open source database (VitalDB, https://vitaldb.net), the patients who underwent general anesthesia with non-invasive monitoring including blood pressure, electrocardiography, pulse oximetry, bispectral index, capnography, and minimal alveolar concentration of inhalation agent.

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The study population included patients who underwent inhaled general anesthesia for non-cardiac surgery between June 2016 and August 2017 at Seoul National University Hospital, Seoul, South Korea.

You may qualify if:

  • The patients who are included in the open database, VtialDB.
  • The patients who underwent inhaled general anesthesia for non-cardiac surgery.
  • The patients who have non-invasive monitoring data including blood pressure, electrocardiography, pulse oximetry, bispectral index, and capnography.

You may not qualify if:

  • The patient with missing data.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung Medical Center

Seoul, Seoul, 06351, South Korea

Location

Related Publications (2)

  • Lee S, Lee HC, Chu YS, Song SW, Ahn GJ, Lee H, Yang S, Koh SB. Deep learning models for the prediction of intraoperative hypotension. Br J Anaesth. 2021 Apr;126(4):808-817. doi: 10.1016/j.bja.2020.12.035. Epub 2021 Feb 6.

    PMID: 33558051BACKGROUND
  • Lee HC, Jung CW. Vital Recorder-a free research tool for automatic recording of high-resolution time-synchronised physiological data from multiple anaesthesia devices. Sci Rep. 2018 Jan 24;8(1):1527. doi: 10.1038/s41598-018-20062-4.

    PMID: 29367620BACKGROUND

Study Officials

  • Hyun Joo Ahn, MD, PhD

    Samsung Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 13, 2023

First Posted

March 9, 2023

Study Start

April 1, 2023

Primary Completion

May 1, 2024

Study Completion

May 1, 2024

Last Updated

March 30, 2025

Record last verified: 2024-05

Locations