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

Not Applicable

Completed

• Conditions: Anesthesia

• Registration Number: NCT05199883
• Lead Sponsor: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Brief 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.

Study Timeline

• Study Start: 2020-12-01
• Primary Completion: 2021-01-31
• Study Completion: 2021-01-31
• Study First Submitted: 2021-10-21
• Status Verified: 2022-01
• Study First Submitted QC: 2022-01-19
• Last Update Submitted: 2022-01-19
• Study First Posted: 2022-01-20
• Last Update Posted: 2022-02-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Adverse Events	during the surgical procedure intervention	An adverse event is defined as any untoward medical occurrence in the study period. Intra-operative adverse events were reported using the institutional incident reporting system. Data was collected in the time between skin incision and the completion of surgical resection.

Secondary Outcome Measures

Name	Time	Method
Stability of the Control Variables	during the surgical procedure intervention	To characterize the patient's repose to surgery, the TI.VA algorithm uses a Decision-Making Matrix drawn by crossing BIS (Min-max: 0-100, optimal range 40-60 ) and Mean Arterial Pressure (Min-max: 0-150mmHg. Optimal range 65-75mmHg). The Optimal anesthesia zone is defined as the area of the Decision-Making Matrix identify by the optimal range for the two control variables (BIS and MAP).; The stability of the control variables during anesthesia was quantified by the percentage of monitoring points registered in the Optimal Anaesthesia Zone during anesthesia.; A monitoring point is understood as a value of BIS and MAP recorded at the same time. The system records a monitoring point every 5 seconds.; Data was collected in the time between skin incision and the completion of surgical resection.
Performance Error analysis	during the surgical procedure intervention	The performance of the algorithm was assessed using the performance error (PE), median PE (MDPE), median absolute PE (MDAPE), and wobble according to the method of Performance Error.; Data was collected in the time between skin incision and the completion of surgical resection.

Trial Locations

Locations (1)

Fondazione IRCCS Istituto Nazionale dei Tumori; 🇮🇹 Milano, Italy