The TI.VA Algorithm: A First-in-Humans Test.
Condition: Anesthesia
Study type: Interventional

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.
    

Intervention name(s): TI.VA algorithm: decision support system
Intervention type(s): Other
Intervention description(s): TI.VA algorithm uses BIS and MAP values as control variables to suggest the intervention on propofol and remifentanil levels.
Intervention model: Single Group Assignment
Intervention model description: This is a prospective study involving a series of consecutive patients.
Masking: None (Open Label)
Primary purpose: Other
Keywords: open feedback control system; Balanced Anaesthesia; Total Intravenous Anaesthesia