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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age19+
SponsorSamsung Medical Center

About this trial

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?

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adults patients aged 19 or more

Elective surgery under general anesthesia

American Society of Anesthesiologists physical status I - III

Disqualifiers

Vasopressor/Inotrope usage before surgery

Patients who needs invasive arterial cannulation

Emergency surgery

Pregnant or lactating women

Trial population

The patients who undergoing general anesthesia with five non-invasive monitoring device (non-invasive blood pressure, electrocardiography, photoplethysmography, capnography, and Bispectral Index)

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • 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.

Treatment groups

200 Participants
are divided into 1 treatment group
Group A: Study group (single group)1 intervention

Trial outcomes

Primary outcomes

1

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

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.

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

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.