AnesthesiaNCT02914444
Registry Construction of Intraoperative Vital Signs and Clinical Information in Surgical Patients
An observational study of Anesthesia and Monitoring, Intraoperative, run by Seoul National University Hospital at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Anesthesia, Monitoring, Intraoperative
- How many people
- 200,000 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Jun 2016to 1 Jun 2025
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients undergoing surgery in Seoul National University Hospital.
Who may be able to join
- Patients undergoing surgery
Who cannot join
- N/A
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Hospital
Seoul
Chul-Woo Jung, MD. PhD, 82-2-2072-2467, jungcwoo@gmail.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Anesthesia, Monitoring, Intraoperative
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: during surgery
Secondary outcomes (4)
Patient weight
Patient weight (kg) is gathered from the electronic medical recording system (EMR).
Measured: baseline
Patient gender
Patient gender (M/F) is gathered from the electronic medical recording system (EMR).
Measured: baseline
Patient age
Patient age (years) is gathered from the electronic medical recording system (EMR).
Measured: baseline
Diagnosis
Patient's diagnosis is gathered from the electronic medical recording system (EMR).
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2016 (estimated)
- Study start1 Jun 2016
- Primary completion1 Jun 2025 (estimated)
- Study completion1 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200,000 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chul-Woo Jung, Seoul National University Hospital
- Investigators
- Chul-Woo Jung, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02914444
- Sponsor's protocol ID
- VitalDB
- Status last verified
- Nov 2023
- First submitted
- 30 Aug 2016
- Last updated
- 1 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Yang HL, Celi LA, Lee H, Park SA, Lee S, Jung CW, Lee HC. The effect of selection bias on the performance of a deep learning-based intraoperative hypotension prediction model using real-world samples from a publicly available database. Br J Anaesth. 2025 Sep;135(3):571-581. doi: 10.1016/j.bja.2025.03.024. Epub 2025 May 22.
PubMed 40404499Chen M, Zhang D. Machine learning-based prediction of post-induction hypotension: identifying risk factors and enhancing anesthesia management. BMC Med Inform Decis Mak. 2025 Feb 22;25(1):96. doi: 10.1186/s12911-025-02930-y.
PubMed 39987101Choe 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.
PubMed 34591024
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Registry Construction of Intraoperative Vital Signs and Clinical Information for Retrospective Cohort Study in Surgical Patients
- ClinicalTrials.gov ID
- NCT02914444
- Acronym / sponsor ID
- VitalDB
- Conditions
- Anesthesia, Monitoring, Intraoperative
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200,000 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 1 Jun 2016 (actual)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 1 Jun 2025 (estimated)
- First posted
- 26 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients undergoing surgery in Seoul National University Hospital.
Key inclusion criteria (1 listed)
- Patients undergoing surgery
Key exclusion criteria (1 listed)
- N/A
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Integrated patient monitoring data (*.vital fime) from multiple anesthesia devices during surgery
Time frame: 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.
4 secondary outcomes
Patient weight
Time frame: baseline
Patient gender
Time frame: baseline
Patient age
Time frame: baseline
Diagnosis
Time frame: baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2023.
- Derived from this study: PubMed 40404499Yang HL, Celi LA, Lee H, Park SA, Lee S, Jung CW, Lee HC. The effect of selection bias on the performance of a deep learning-based intraoperative hypotension prediction model using real-world samples from a publicly available database. Br J Anaesth. 2025 Sep;135(3):571-581. doi: 10.1016/j.bja.2025.03.024. Epub 2025 May 22.
- Derived from this study: PubMed 39987101Chen M, Zhang D. Machine learning-based prediction of post-induction hypotension: identifying risk factors and enhancing anesthesia management. BMC Med Inform Decis Mak. 2025 Feb 22;25(1):96. doi: 10.1186/s12911-025-02930-y.
- Derived from this study: PubMed 34591024Choe 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chul-Woo Jung principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anesthesia and Monitoring, Intraoperative, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chul-Woo Jung (82-10-8984-4611, jungcwoo@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Integrated patient monitoring data (*.vital fime) from multiple anesthesia devices during surgery (time frame: during surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02914444, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2023; AzTrials last refreshed its copy on 8 Nov 2026.