Decision Support System for Anesthetists for In-room Monitoring of the Level of Consciousness, Neuro-muscular Blocking and Nociception Employing Data Fusion and Artificial Intelligence
试验速览
- 阶段
- 不适用
- 入组人数
- 360
- 试验地点
- 1
- 主要终点
- Arterial blood pressure
研究概览
简要总结
The balanced anesthesia process contains three main parts: the control of hypnosis, analgesia, and neuromuscular blockade. For the induction phase, the anesthesiologist performs protocols based on prior planning specific to each patient and usually performs these controls by monitoring the classic vital signs and other clinical signs for the maintenance phase.
In a way, this professional is the controller in a control system that acts on the plant (the patient) through the infusion of hypnotic drugs, analgesics and neuromuscular blockers. In addition, the anesthesiologist estimates the state of consciousness, the level of analgesia and the level of neuromuscular blockage through other indirect measures, as well as a state observer.
There are different techniques for direct monitoring of these three anesthesia variables (DoA, NMB and NoL), such as BIS and Narcotrend, but all have some disadvantages, especially when the anesthesia process combines different drugs. This work proposes a new way of evaluating DoA, NMB and NoL using data fusion techniques to combine classical clinical signs with advanced EEG monitoring techniques to provide a decision support system for the anesthesiologist.
详细描述
The balanced anesthesia process contains three main parts: the control of hypnosis, the analgesia and neuromuscular blockade. For the induction phase, the anesthesiologist performs protocols based on prior planning specific to each patient. Normally, the anesthesiologist controls the process by monitoring the classical vital signs and other clinical most common signs during the maintenance phase. In a way, this professional is the controller in a control system that acts on the plant (the patient) through the infusion of hypnotic and analgesic drugs and neuromuscular blockers.
In addition, the anesthesiologist estimates the the level of consciousness, of nociception and the level of neuromuscular blockade through these indirect measurements, just as a state observer in a control system would do.
There are different techniques for the direct monitoring of these three variables of anesthesia (DoA, NMB and NoL), such as BIS and Narcotrend, but all of them present a few disadvantages and mis-measurements, especially when the anesthesia process combines different drugs.
This work proposes a new way of evaluating DoA, NMB and NoL, using techniques to combine classical clinical signs with advanced EEG monitoring, to provide a decision support system for the anesthesiologist.
For this, we will perform data acquisition from the equipment usually used in surgical procedures with general anesthesia, such as ECG, EEG, blood pressure, mechanical ventilation, among others.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Crossover
- 时间视角
- Prospective
入排标准
- 年龄范围
- 1 Month 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients under general anesthesia
排除标准
- •Cerebral Palsy patients
结局指标
主要结局
Arterial blood pressure
时间窗: 2 to 3 months of different surgical procedures
P_INV - Invasive blood pressure - unit: \[mmHg\], will be stored in real time during the surgical procedure.
Non Invasive Blood pressure
时间窗: 2 to 3 months of different surgical procedures
P_NINV - Non Invasive blood pressure - unit: \[mmHg/mmHg\], will be stored in real time during the surgical procedure.
Heart Rate
时间窗: 2 to 3 months of different surgical procedures
HR - Heart Rate - unit: \[bpm\], will be stored in real time during the surgical procedure.
Inspired carbon dioxide concentration
时间窗: 2 to 3 months of different surgical procedures
FiCO2 - CO2 inspired Fraction - unit: \[% of Volume\], will be stored in real time during the surgical procedure.
Inspired Nitrous Oxide concentration
时间窗: 2 to 3 months of different surgical procedures
FiN2O - N2O inspired Fraction - unit: \[% of Volume\], will be stored in real time during the surgical procedure.
Preoperative patient medical records - Clinical state of the patient - Age
时间窗: 2 to 3 months of different surgical procedures
Anesthesia related preoperative information from the patient, such as: I - Age - unit: \[years\]
Preoperative patient medical records - Clinical state of the patient - gender
时间窗: 2 to 3 months of different surgical procedures
Anesthesia related preoperative information from the patient, such as: G - Gender - unit: Male or Female
Anesthetic agent infusion rate
时间窗: 2 to 3 months of different surgical procedures
IR_Anes - Infusion Rate of anesthetic agent - unit: \[mg/hr\], will be stored in real time during the surgical procedure.
Analgesic agent infusion rate
时间窗: 2 to 3 months of different surgical procedures
IR_Analg - Infusion rate of Analgesic agent - unit: \[mg/hr\], will be stored in real time during the surgical procedure.
Ventilation Tidal volume
时间窗: 2 to 3 months of different surgical procedures
Vt - Tidal Volume - unit: \[mL\], will be stored in real time during the surgical procedure.
Ventilation PEEP
时间窗: 2 to 3 months of different surgical procedures
PEEP - Positive end of expiration pressure - unit: \[cmH2O\], will be stored in real time during the surgical procedure.
Preoperative patient medical records - General state of the patient in ASA.
时间窗: 2 to 3 months of different surgical procedures
Anesthesia related preoperative information from the patient, such as prior use of opioids, ASA and METS indexes. ASA - Physical state of the patient - unit: \[u\] P1 to P5
Mean Arterial Pressure
时间窗: 2 to 3 months of different surgical procedures
MAP - Mean Arterial Pressure - unit: \[mmHg\], will be stored in real time during the surgical procedure.
Neuro-muscular Block agent infusion rate
时间窗: 2 to 3 months of different surgical procedures
IR_NMB - Infusion rate of neuro-muscular block agent - unit: \[mg/hr\], will be stored in real time during the surgical procedure.
Ventilation maximum pressure per cycle
时间窗: 2 to 3 months of different surgical procedures
Pmax - Maximum pressure during the inspiration cycle - unit: \[cmH2O\], will be stored in real time during the surgical procedure.
Ventilation Plateau pressure
时间窗: 2 to 3 months of different surgical procedures
Pplateau - Plateau pressure during the inspiration cycle - unit: \[cmH2O\], will be stored in real time during the surgical procedure.
Blood oxygen saturation
时间窗: 2 to 3 months of different surgical procedures
SpO2 - Peripheral capillary oxygen saturation - unit: \[%\], will be stored in real time during the surgical procedure.
Exhaled Anesthetic concentration
时间窗: 2 to 3 months of different surgical procedures
EtAA - Anesthetic agents Exhaled Fraction - unit: \[% of Volume\], will be stored in real time during the surgical procedure.
Ventilation respiratory rate
时间窗: 2 to 3 months of different surgical procedures
RR - Respiratory Rate - unit: \[bpm\], will be stored in real time during the surgical procedure.
Ventilation Minute Volume
时间窗: 2 to 3 months of different surgical procedures
Vm - Minute Volume - unit: \[L/min\], will be stored in real time during the surgical procedure.
Conscience Level
时间窗: 2 to 3 months of diferent surgical procedures
CL - Consciousnesses Level (through BIS) - unit: \[u 0-100\] will be stored in real time during the surgical procedure.
Inspired anesthetic concentration
时间窗: 2 to 3 months of different surgical procedures
FiAA - Inspired fraction of anesthetic agent - unit: \[% of Volume\], will be stored in real time during the surgical procedure.
Exhaled Carbon Dioxide concentration
时间窗: 2 to 3 months of different surgical procedures
EtCO2 - End-tidal CO2 concentration (CO2 Exhaled Fraction) - unit: \[% of Volume\], will be stored in real time during the surgical procedure.
Preoperative patient medical records - General state of the patient in METS.
时间窗: 2 to 3 months of different surgical procedures
Anesthesia related preoperative information from the patient, such as prior use of opioids, ASA and METS indexes. METS - Functional state of the patient - unit: \[u\]
Primary anesthesia Data - related to the manual infusion of drugs
时间窗: 2 to 3 months of different surgical procedures
Every monitored clinical variable, related to the manual infusion of drugs, will be stored in real time during the surgical procedure. Every infusion made manually by the anesthesiologist during the procedure should be recorded, always considering the total amount infused and the time it occurred.
Preoperative patient medical records - Clinical state of the patient - Height
时间窗: 2 to 3 months of different surgical procedures
Anesthesia related preoperative information from the patient, such as: A - Height - unit: \[cm\]
Preoperative patient medical records - Clinical state of the patient - Weight
时间窗: 2 to 3 months of different surgical procedures
Anesthesia related preoperative information from the patient, such as: P - Weight - unit: \[Kg\]
次要结局
未报告次要终点
研究者
Joaquim Edson Vieira
Phd Anesthesiology Professor and Principal invesigator
University of Sao Paulo General Hospital