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

Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02914444
• Other study ID #: VitalDB
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

• Anesthesia
• Monitoring, Intraoperative

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