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Decision Support System for Anesthetists

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04079036
Acronym
Serenity
Enrollment
360
Registered
2019-09-06
Start date
2019-10-31
Completion date
2020-01-31
Last updated
2019-09-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia

Keywords

General Anesthesia, Anesthesia Awareness, Anesthesia overdose

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.

Interventions

None listed

Sponsors

University of Sao Paulo General Hospital
Lead SponsorOTHER
University of Sao Paulo
CollaboratorOTHER
Fundação de Amparo à Pesquisa do Estado de São Paulo
CollaboratorOTHER_GOV

Study design

Observational model
CASE_CROSSOVER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
1 Months to 80 Years
Healthy volunteers
Yes

Inclusion criteria

* Patients under general anesthesia

Exclusion criteria

* Cerebral Palsy patients

Design outcomes

Primary

MeasureTime frameDescription
Heart Rate2 to 3 months of different surgical proceduresHR - Heart Rate - unit: \[bpm\], will be stored in real time during the surgical procedure.
Arterial blood pressure2 to 3 months of different surgical proceduresP\_INV - Invasive blood pressure - unit: \[mmHg\], will be stored in real time during the surgical procedure.
Mean Arterial Pressure2 to 3 months of different surgical proceduresMAP - Mean Arterial Pressure - unit: \[mmHg\], will be stored in real time during the surgical procedure.
Non Invasive Blood pressure2 to 3 months of different surgical proceduresP\_NINV - Non Invasive blood pressure - unit: \[mmHg/mmHg\], will be stored in real time during the surgical procedure.
Conscience Level2 to 3 months of diferent surgical proceduresCL - Consciousnesses Level (through BIS) - unit: \[u 0-100\] will be stored in real time during the surgical procedure.
Inspired anesthetic concentration2 to 3 months of different surgical proceduresFiAA - Inspired fraction of anesthetic agent - unit: \[% of Volume\], will be stored in real time during the surgical procedure.
Inspired carbon dioxide concentration2 to 3 months of different surgical proceduresFiCO2 - CO2 inspired Fraction - unit: \[% of Volume\], will be stored in real time during the surgical procedure.
Inspired Nitrous Oxide concentration2 to 3 months of different surgical proceduresFiN2O - N2O inspired Fraction - unit: \[% of Volume\], will be stored in real time during the surgical procedure.
Blood oxygen saturation2 to 3 months of different surgical proceduresSpO2 - Peripheral capillary oxygen saturation - unit: \[%\], will be stored in real time during the surgical procedure.
Exhaled Carbon Dioxide concentration2 to 3 months of different surgical proceduresEtCO2 - End-tidal CO2 concentration (CO2 Exhaled Fraction) - unit: \[% of Volume\], will be stored in real time during the surgical procedure.
Exhaled Anesthetic concentration2 to 3 months of different surgical proceduresEtAA - Anesthetic agents Exhaled Fraction - unit: \[% of Volume\], will be stored in real time during the surgical procedure.
Anesthetic agent infusion rate2 to 3 months of different surgical proceduresIR\_Anes - Infusion Rate of anesthetic agent - unit: \[mg/hr\], will be stored in real time during the surgical procedure.
Analgesic agent infusion rate2 to 3 months of different surgical proceduresIR\_Analg - Infusion rate of Analgesic agent - unit: \[mg/hr\], will be stored in real time during the surgical procedure.
Neuro-muscular Block agent infusion rate2 to 3 months of different surgical proceduresIR\_NMB - Infusion rate of neuro-muscular block agent - unit: \[mg/hr\], will be stored in real time during the surgical procedure.
Ventilation respiratory rate2 to 3 months of different surgical proceduresRR - Respiratory Rate - unit: \[bpm\], will be stored in real time during the surgical procedure.
Ventilation Tidal volume2 to 3 months of different surgical proceduresVt - Tidal Volume - unit: \[mL\], will be stored in real time during the surgical procedure.
Ventilation Minute Volume2 to 3 months of different surgical proceduresVm - Minute Volume - unit: \[L/min\], will be stored in real time during the surgical procedure.
Ventilation maximum pressure per cycle2 to 3 months of different surgical proceduresPmax - Maximum pressure during the inspiration cycle - unit: \[cmH2O\], will be stored in real time during the surgical procedure.
Ventilation Plateau pressure2 to 3 months of different surgical proceduresPplateau - Plateau pressure during the inspiration cycle - unit: \[cmH2O\], will be stored in real time during the surgical procedure.
Ventilation PEEP2 to 3 months of different surgical proceduresPEEP - Positive end of expiration pressure - unit: \[cmH2O\], will be stored in real time during the surgical procedure.
Primary anesthesia Data - related to the manual infusion of drugs2 to 3 months of different surgical proceduresEvery 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 - General state of the patient in ASA.2 to 3 months of different surgical proceduresAnesthesia 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 - General state of the patient in METS.2 to 3 months of different surgical proceduresAnesthesia related preoperative information from the patient, such as prior use of opioids, ASA and METS indexes. METS - Functional state of the patient - unit: \[u\]
Preoperative patient medical records - Clinical state of the patient - Age2 to 3 months of different surgical proceduresAnesthesia related preoperative information from the patient, such as: I - Age - unit: \[years\]
Preoperative patient medical records - Clinical state of the patient - gender2 to 3 months of different surgical proceduresAnesthesia related preoperative information from the patient, such as: G - Gender - unit: Male or Female
Preoperative patient medical records - Clinical state of the patient - Weight2 to 3 months of different surgical proceduresAnesthesia related preoperative information from the patient, such as: P - Weight - unit: \[Kg\]
Preoperative patient medical records - Clinical state of the patient - Height2 to 3 months of different surgical proceduresAnesthesia related preoperative information from the patient, such as: A - Height - unit: \[cm\]

Countries

Brazil

Contacts

Primary ContactBruno B Turrin, Msc
bbturrin@usp.br+5511998745879

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026