Registry Construction of Intraoperative Vital Signs and Clinical Information in Surgical Patients

Registry Construction of Intraoperative Vital Signs and Clinical Information for Retrospective Cohort Study in Surgical Patients

Monitoring data during anesthesia of surgical patient in the operation room will be collected and stored into the registry automatically. Patients' information and preoperative assessment from medical records will be included. Furthermore, intraoperative events will integrated and entered in the registry.

The purpose of the registry is to establish an automatic and accessible database of surgical patients for further retrospective studies.

Study Overview

• Status: Recruiting
• Conditions: Anesthesia; Monitoring, Intraoperative

Detailed Description

Capture and storage of vital signs data are performed with our own developed data gathering program, Vital Recorder. The Vital Recorder program is a Windows® software and acquires time-synced patient monitoring data from the serial ports of multiple anesthesia devices like patient monitor, anesthesia machine, bispectral index monitor, cardiac output monitor, infusion pumps, etc. The retrieved data are stored on the local or network data storage.

Variables captured by the Vital Recorder program are as follows: heart rate, blood pressure, saturation, temperature, respiratory parameters, bispectral index, infusion history of target-controlled infusion pump, cardiac output, cerebral oxygen concentration, etc.

Time interval of the data is 1-2 sec for numeric variables. Resolution of waves (analog data such as ECG, plethysmogram, and pressure waves) is usually 500 Hz. Captured data of a patient is stored as a *.vital file.

A laptop is connected to 4-6 anesthesia devices at the same time via serial connections. Patients enrolled (all of the surgical patients who undergo surgery at our hospital) receive routine anesthesia and surgery. Due to the program's automatic function, the program identifies the start and end of a case then automatically records the vital signs of every patient 24/365, once the program starts.

Patient information is additionally gathered from the electronic medical recording system (EMR). Data from the EMR are as follows: sex, age, weight, height, diagnosis, operation, anesthesia and surgery times, premedical history, perioperative lab data and medication.

List of vital files and patient information is integrated in an encrypted spreadsheet file.

• Study Type: Observational
• Enrollment (Estimated): 200000

Contacts and Locations

• Study Contact: Name: Chul-Woo Jung; Phone Number: 82-10-8984-4611; Email: jungcwoo@gmail.com

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Recruiting
    • Seoul National University Hospital
    • Contact: Chul-Woo Jung, MD. PhD; Phone Number: 82-2-2072-2467; Email: jungcwoo@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing surgery in Seoul National University Hospital.

Description

Inclusion Criteria:

• Patients undergoing surgery

Exclusion Criteria:

• N/A

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Integrated patient monitoring data (*.vital fime) from multiple anesthesia devices during surgery	Variables captured by the Vital Recorder program are as follows: heart rate, blood pressure, saturation, temperature, respiratory parameters, bispectral index, infusion history of target-controlled infusion pump, cardiac output, cerebral oxygen concentration, etc. Time interval of the data is 1-2 sec for numeric variables. Resolution of waves (analog data such as ECG, plethysmography, and pressure waves) is usually 500 Hz. All the values of abovementioned variables are stored as a single file per patient case, with the extension of *.vital that is created by the Vital Recorder program. Due to the program's automatic function, the program identifies the start and end of a case then automatically records the vital signs of every patient 24/365, once the program starts.	during surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient weight	Patient weight (kg) is gathered from the electronic medical recording system (EMR).	baseline
Patient gender	Patient gender (M/F) is gathered from the electronic medical recording system (EMR).	baseline
Patient age	Patient age (years) is gathered from the electronic medical recording system (EMR).	baseline
Diagnosis	Patient's diagnosis is gathered from the electronic medical recording system (EMR).	baseline

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Investigators: Principal Investigator: Chul-Woo Jung, Seoul National University Hospital

Publications and helpful links

General Publications

• Choe S, Park E, Shin W, Koo B, Shin D, Jung C, Lee H, Kim J. Short-Term Event Prediction in the Operating Room (STEP-OP) of Five-Minute Intraoperative Hypotension Using Hybrid Deep Learning: Retrospective Observational Study and Model Development. JMIR Med Inform. 2021 Sep 30;9(9):e31311. doi: 10.2196/31311.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2016
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): June 1, 2025

Study Registration Dates

• First Submitted: August 30, 2016
• First Submitted That Met QC Criteria: September 23, 2016
• First Posted (Estimated): September 26, 2016

Study Record Updates

• Last Update Posted (Actual): December 1, 2023
• Last Update Submitted That Met QC Criteria: November 29, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: VitalDB

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED