Decision Support System for Anesthetists

Anesthesia Clinical Trial

— Serenity  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04079036
• Other study ID #: CAAE 03424918.6.0000.0068
• Status: Not yet recruiting
• Start date: October 2019
• Est. completion date: January 2020

Study information

• Verified date: September 2019
• Source: University of Sao Paulo General Hospital
• Contact: Bruno B Turrin, Msc
• Phone: +5511998745879
• Email: bbturrin[@]usp.br
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 360
• Est. completion date: January 2020
• Est. primary completion date: December 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Month to 80 Years

Eligibility

Inclusion Criteria:

• Patients under general anesthesia

Exclusion Criteria:

• Cerebral Palsy patients

Related Conditions & MeSH terms

• Anesthesia

Locations

Country	Name	City	State
Brazil	Hospital das Clínicas - Faculdade de Medicina da Universidade de Sao Paulo	São Paulo

Sponsors (3)

Lead Sponsor	Collaborator
University of Sao Paulo General Hospital	Fundação de Amparo à Pesquisa do Estado de São Paulo, University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

References & Publications (4)

Ahmad AM. Recent advances in pharmacokinetic modeling. Biopharm Drug Dispos. 2007 Apr;28(3):135-43. Review. — View Citation

Iselin-Chaves IA, Flaishon R, Sebel PS, Howell S, Gan TJ, Sigl J, Ginsberg B, Glass PS. The effect of the interaction of propofol and alfentanil on recall, loss of consciousness, and the Bispectral Index. Anesth Analg. 1998 Oct;87(4):949-55. — View Citation

Karl J Åström, Björn Wittenmark. Computer-Controlled Systems: Theory and Design. Dover Books on Electrical Engineering. ISBN: 0486284042. Courier Corporation, 2013

Schnider TW, Minto CF, Struys MM, Absalom AR. The Safety of Target-Controlled Infusions. Anesth Analg. 2016 Jan;122(1):79-85. doi: 10.1213/ANE.0000000000001005. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Heart Rate	HR - Heart Rate - unit: [bpm], will be stored in real time during the surgical procedure.	2 to 3 months of different surgical procedures
Primary	Arterial blood pressure	P_INV - Invasive blood pressure - unit: [mmHg], will be stored in real time during the surgical procedure.	2 to 3 months of different surgical procedures
Primary	Mean Arterial Pressure	MAP - Mean Arterial Pressure - unit: [mmHg], will be stored in real time during the surgical procedure.	2 to 3 months of different surgical procedures
Primary	Non Invasive Blood pressure	P_NINV - Non Invasive blood pressure - unit: [mmHg/mmHg], will be stored in real time during the surgical procedure.	2 to 3 months of different surgical procedures
Primary	Conscience Level	CL - Consciousnesses Level (through BIS) - unit: [u 0-100] will be stored in real time during the surgical procedure.	2 to 3 months of diferent surgical procedures
Primary	Inspired anesthetic concentration	FiAA - Inspired fraction of anesthetic agent - unit: [% of Volume], will be stored in real time during the surgical procedure.	2 to 3 months of different surgical procedures
Primary	Inspired carbon dioxide concentration	FiCO2 - CO2 inspired Fraction - unit: [% of Volume], will be stored in real time during the surgical procedure.	2 to 3 months of different surgical procedures
Primary	Inspired Nitrous Oxide concentration	FiN2O - N2O inspired Fraction - unit: [% of Volume], will be stored in real time during the surgical procedure.	2 to 3 months of different surgical procedures
Primary	Blood oxygen saturation	SpO2 - Peripheral capillary oxygen saturation - unit: [%], will be stored in real time during the surgical procedure.	2 to 3 months of different surgical procedures
Primary	Exhaled Carbon Dioxide concentration	EtCO2 - End-tidal CO2 concentration (CO2 Exhaled Fraction) - unit: [% of Volume], will be stored in real time during the surgical procedure.	2 to 3 months of different surgical procedures
Primary	Exhaled Anesthetic concentration	EtAA - Anesthetic agents Exhaled Fraction - unit: [% of Volume], will be stored in real time during the surgical procedure.	2 to 3 months of different surgical procedures
Primary	Anesthetic agent infusion rate	IR_Anes - Infusion Rate of anesthetic agent - unit: [mg/hr], will be stored in real time during the surgical procedure.	2 to 3 months of different surgical procedures
Primary	Analgesic agent infusion rate	IR_Analg - Infusion rate of Analgesic agent - unit: [mg/hr], will be stored in real time during the surgical procedure.	2 to 3 months of different surgical procedures
Primary	Neuro-muscular Block agent infusion rate	IR_NMB - Infusion rate of neuro-muscular block agent - unit: [mg/hr], will be stored in real time during the surgical procedure.	2 to 3 months of different surgical procedures
Primary	Ventilation respiratory rate	RR - Respiratory Rate - unit: [bpm], will be stored in real time during the surgical procedure.	2 to 3 months of different surgical procedures
Primary	Ventilation Tidal volume	Vt - Tidal Volume - unit: [mL], will be stored in real time during the surgical procedure.	2 to 3 months of different surgical procedures
Primary	Ventilation Minute Volume	Vm - Minute Volume - unit: [L/min], will be stored in real time during the surgical procedure.	2 to 3 months of different surgical procedures
Primary	Ventilation maximum pressure per cycle	Pmax - Maximum pressure during the inspiration cycle - unit: [cmH2O], will be stored in real time during the surgical procedure.	2 to 3 months of different surgical procedures
Primary	Ventilation Plateau pressure	Pplateau - Plateau pressure during the inspiration cycle - unit: [cmH2O], will be stored in real time during the surgical procedure.	2 to 3 months of different surgical procedures
Primary	Ventilation PEEP	PEEP - Positive end of expiration pressure - unit: [cmH2O], will be stored in real time during the surgical procedure.	2 to 3 months of different surgical procedures
Primary	Primary anesthesia Data - related to the manual infusion of drugs	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.	2 to 3 months of different surgical procedures
Primary	Preoperative patient medical records - General state of the patient in ASA.	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	2 to 3 months of different surgical procedures
Primary	Preoperative patient medical records - General state of the patient in METS.	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]	2 to 3 months of different surgical procedures
Primary	Preoperative patient medical records - Clinical state of the patient - Age	Anesthesia related preoperative information from the patient, such as: I - Age - unit: [years]	2 to 3 months of different surgical procedures
Primary	Preoperative patient medical records - Clinical state of the patient - gender	Anesthesia related preoperative information from the patient, such as: G - Gender - unit: Male or Female	2 to 3 months of different surgical procedures
Primary	Preoperative patient medical records - Clinical state of the patient - Weight	Anesthesia related preoperative information from the patient, such as: P - Weight - unit: [Kg]	2 to 3 months of different surgical procedures
Primary	Preoperative patient medical records - Clinical state of the patient - Height	Anesthesia related preoperative information from the patient, such as: A - Height - unit: [cm]	2 to 3 months of different surgical procedures