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

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Status: Completed

Conditions: Anesthesia

Treatments: Other: TI.VA algorithm: decision support system

Study type: Interventional

Funder types: Other

Identifiers

NCT05199883

INT150/20

Details and patient eligibility

About

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.

Full 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.

Enrollment: 5 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

The inclusion criteria were: :

• age 18-65 years at the time of recruitment.
• candidates for curative surgery for breast cancer.
• American Society of Anaesthesiologists (ASA) status I/II.

The exclusion criteria were:

• ASA status > II.
• counter-indications for use of the drugs employed in this protocol.
• pregnancy or lactation.
• incapacity to understand the study explanation and sign the informed consent form.

These criteria were selected according to the risk mitigation strategy described in the protocol.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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5 participants in 1 patient group

TI.VA group

Experimental group

Description:

The titration of Propofol and Remifentanil levels will be guided by TI.VA algorithm in the time between skin incision and completion of surgical resection.

Treatment:

Other: TI.VA algorithm: decision support system