Decision Support System for Anesthetists

NCT04079036 | Unknown DMC

• 1 other identifier: CAAE 03424918.6.0000.0068
• Study Type: observational
• Target: 360
• Locations: 1 country
• Sites: 1

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.

Conditions

Anesthesia

Keywords

General Anesthesia; Anesthesia Awareness; Anesthesia overdose

Outcome Measures

Primary Outcomes (27)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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 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

• 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

• 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

• 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

• 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

• 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

• 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

Study Arms (12)

Underweight Adult Male

Male patients with Underweight BMI classification and more than 20 years old https://www.cdc.gov/healthyweight/assessing/bmi/adult\_bmi/index.html

Healthy Weight Adult Male

Male patients with Healthy Weight BMI classification and more than 20 years old

Overweight Adult Male

Male patients with OverWeight or Obese BMI classification and more than 20 years old

Underweight Adult Female

Female patients with Underweight BMI classification and more than 20 years old

Healthy Weight Adult Female

Female patients with Healthy Weight BMI classification and more than 20 years old

Overweight Adult Female

Female patients with Overweight or Obese BMI classification and more than 20 years old

Underweight children Male

Male patients less than 20 year old, and with Underweight BMI classification https://www.cdc.gov/healthyweight/assessing/bmi/childrens\_bmi/about\_childrens\_bmi.html

Healthy Weight children Male

Male patients less than 20 year old, and with Healthy Weight BMI classification

Overweight children Male

Male patients less than 20 year old, and with Overweight or Obese BMI classification

Underweight children Female

Male patients less than 20 year old, and with Underweight BMI classification https://www.cdc.gov/healthyweight/assessing/bmi/childrens\_bmi/about\_childrens\_bmi.html

Healthy Weight children Female

Female patients less than 20 year old, and with Overweight or Obese BMI classification

Overweight children Female

Female patients less than 20 year old, and with Overweight or Obese BMI classification

Eligibility Criteria

• Age: 1 Month - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients undergoing surgical procedures with general anesthesia

You may qualify if:

• Patients under general anesthesia

You may not qualify if:

• Cerebral Palsy patients

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead
• University of Sao Paulo: collaborator
• Fundação de Amparo à Pesquisa do Estado de São Paulo: collaborator

Study Sites (1)

Hospital das Clínicas - Faculdade de Medicina da Universidade de Sao Paulo

São Paulo, 01246-903, Brazil

Location

Related Publications (4)

• 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.

  PMID: 26516801 BACKGROUND

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

  BACKGROUND

• Ahmad AM. Recent advances in pharmacokinetic modeling. Biopharm Drug Dispos. 2007 Apr;28(3):135-43. doi: 10.1002/bdd.540.

  PMID: 17295411 RESULT

• 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. doi: 10.1097/00000539-199810000-00038.

  PMID: 9768800 RESULT

MeSH Terms

Conditions

Intraoperative Awareness

Condition Hierarchy (Ancestors)

Intraoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Joaquim E Vieira, MD, PhD

  University of Sao Paulo School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bruno B Turrin, Msc

CONTACT

+5511998745879; bbturrin@usp.br

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Target Duration: 20 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Phd Anesthesiology Professor and Principal invesigator

Study Record Dates

• First Submitted: July 10, 2019
• First Posted: September 6, 2019
• Study Start: October 1, 2019
• Primary Completion: December 1, 2019
• Study Completion: January 1, 2020
• Last Updated: September 6, 2019

Record last verified: 2019-09

Locations

BR (1)