Decision Support System for Anesthetists

• Conditions: Anesthesia

• Registration Number: NCT04079036
• Lead Sponsor: University of Sao Paulo General Hospital

Brief Summary

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.

Detailed Description

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.

In short, all data of the patient's vital signs during the procedure and the actions taken by the anesthesiologist and surgeons.

The data will be concentrated on a specific equipment, and will be analyzed together with the data of other patients to improve the mathematical models involved in the process.

Study Timeline

• Study First Submitted: 2019-07-10
• Status Verified: 2019-09
• Study First Submitted QC: 2019-09-04
• Last Update Submitted: 2019-09-04
• Study First Posted: 2019-09-06
• Last Update Posted: 2019-09-06
• Study Start: 2019-10
• Primary Completion: 2019-12
• Study Completion: 2020-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 360

Inclusion Criteria

• Patients under general anesthesia

Exclusion Criteria

• Cerebral Palsy patients

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Arterial blood pressure	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	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	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	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	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.
Anesthetic agent infusion rate	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	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	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	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.	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
Preoperative patient medical records - Clinical state of the patient - Age	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	2 to 3 months of different surgical procedures	Anesthesia related preoperative information from the patient, such as: G - Gender - unit: Male or Female
Mean Arterial Pressure	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	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	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	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	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	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	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	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	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	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	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.	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	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	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	2 to 3 months of different surgical procedures	Anesthesia related preoperative information from the patient, such as: P - Weight - unit: \[Kg\]

Trial Locations

Locations (1)

Hospital das Clínicas - Faculdade de Medicina da Universidade de Sao Paulo; 🇧🇷 São Paulo, Brazil