Clinical trial NCT02914444: Registry Construction of Intraoperative Vital Signs and Clinical Information in Surgical Patients
Official title: Registry Construction of Intraoperative Vital Signs and Clinical Information for Retrospective Cohort Study in Surgical Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Anesthesia
Monitoring, Intraoperative
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2016-09-26
Enrollment: 200000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing surgery in Seoul National University Hospital.

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* Patients undergoing surgery

Exclusion Criteria:

* N/A

Primary outcomes:
measure: Integrated patient monitoring data (*.vital fime) from multiple anesthesia devices during surgery
timeFrame: during surgery
Secondary outcomes:
measure: Patient weight
timeFrame: baseline
measure: Patient gender
timeFrame: baseline
measure: Patient age
timeFrame: baseline
measure: Diagnosis
timeFrame: baseline
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Chul-Woo Jung
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.