NCT05199883

The TI.VA Algorithm: A First-in-Humans Test.

The TI.VA Algorithm: Vector Analysis Applied to a Decision-Making Matrix to Model the Reactive Control Strategy During General Anesthesia: a First-in-Humans Test.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The TI.VA algorithm is a new method to titrate the anesthetic drug concentrations whenever the planned level of anesthesia results to be not appropriate to blunt the patient's reaction to surgical stimulation. TI.VA is a multiple inputs/multiple outputs algorithm. The control variables are the bispectral index (BIS) and the mean arterial pressure (MAP) combined in a decision-making matrix. The optimal range for the two control variables (BIS: 540-60 and MAP: 65-75 mmHg) identified the Optimal Anesthesia Zone (OAZ) at the center of the matrix. Any time one or both control variables escape from the PAZ, the algorithm proposes an intervention on the hypnotic and/or opioid levels (algorithm outputs). A First-in-Humans study was designed to capture preliminary data on the safety and performance of the TI.VA algorithm.

Detailed description

The TI.VA algorithm is a new method to titrate the anesthetic drug concentrations whenever the planned level of anesthesia results to be not appropriate to blunt the patient's reaction to surgical stimulation. TI.VA is a multiple inputs/multiple outputs algorithm. The control variables are the bispectral index (BIS) and the mean arterial pressure (MAP) combined in a decision-making matrix (DMM). The optimal range for the two control variables (BIS: 540-60 and MAP: 65-75 mmHg) identified the Optimal Anesthesia Zone (OAZ) at the center of the matrix. Any time one or both control variables escape from the OAZ, the algorithm quantifies the inadequacy of anesthesia level through a vector connecting the patient's current position on the DMM to the central point identified by the coordinates BIS= 50 and MAP = 75mmHg. Thereafter, the analysis of the vector main components allows the generation of two coefficients that are used to set out a balanced intervention on the hypnotic and opioid levels (algorithm outputs). A First-in-Humans study was designed to capture preliminary data on the safety and performance of the TI.VA algorithm This is a prospective study involving a single cohort of patients without major comorbidity and candidate for minor superficial surgery. All patients received Propofol and Remifentanil administered by TCI systems as part of Total Intravenous Anaesthesia. The algorithm was tested during maintenance of anesthesia defined as the period between skin incision and completion of surgical resection. In this step of the procedure, the titration strategy for anesthetic drug concentrations was suggested by TI.VA algorithm. Data was collected automatically using dedicated software.

Conditions

• Anesthesia

Interventions

Type	Name	Description
OTHER	TI.VA algorithm: decision support system	TI.VA algorithm uses BIS and MAP values as control variables to suggest the intervention on propofol and remifentanil levels.

Timeline

• Start date: 2020-12-01
• Primary completion: 2021-01-31
• Completion: 2021-01-31
• First posted: 2022-01-20
• Last updated: 2022-02-03

Locations

1 site across 1 country: Italy