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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02914444
Other study ID # VitalDB
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date June 1, 2016
Est. completion date June 1, 2025

Study information

Verified date November 2023
Source Seoul National University Hospital
Contact Chul-Woo Jung
Phone 82-10-8984-4611
Email jungcwoo@gmail.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 200000
Est. completion date June 1, 2025
Est. primary completion date June 1, 2025
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Patients undergoing surgery Exclusion Criteria: - N/A

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Korea, Republic of Seoul National University Hospital Seoul

Sponsors (1)

Lead Sponsor Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Patient weight Patient weight (kg) is gathered from the electronic medical recording system (EMR). baseline
Secondary Patient gender Patient gender (M/F) is gathered from the electronic medical recording system (EMR). baseline
Secondary Patient age Patient age (years) is gathered from the electronic medical recording system (EMR). baseline
Secondary Diagnosis Patient's diagnosis is gathered from the electronic medical recording system (EMR). baseline
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