Registry Construction of Intraoperative Vital Signs and Clinical Information for Retrospective Cohort Study in Surgical Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200,000
- 试验地点
- 1
- 主要终点
- Integrated patient monitoring data (*.vital fime) from multiple anesthesia devices during surgery
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing surgery
排除标准
- 未提供
结局指标
主要结局
Integrated patient monitoring data (*.vital fime) from multiple anesthesia devices during surgery
时间窗: 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.
次要结局
- Patient weight(baseline)
- Patient gender(baseline)
- Diagnosis(baseline)
- Patient age(baseline)
研究者
Chul-Woo Jung
Associate Professor
Seoul National University Hospital