NCT05199883

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2021

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

October 21, 2021

Completed
3 months until next milestone

First Posted

Study publicly available on registry

January 20, 2022

Completed
Last Updated

February 3, 2022

Status Verified

January 1, 2022

Enrollment Period

2 months

First QC Date

October 21, 2021

Last Update Submit

January 19, 2022

Conditions

Anesthesia

Keywords

open feedback control systemBalanced AnaesthesiaTotal Intravenous Anaesthesia

Outcome Measures

Primary Outcomes (1)

  • Adverse Events

    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.

    during the surgical procedure intervention

Secondary Outcomes (2)

  • Stability of the Control Variables

    during the surgical procedure intervention

  • Performance Error analysis

    during the surgical procedure intervention

Study Arms (1)

TI.VA group

EXPERIMENTAL

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.

Other: TI.VA algorithm: decision support system

Interventions

TI.VA algorithm: decision support systemOTHER

TI.VA algorithm uses BIS and MAP values as control variables to suggest the intervention on propofol and remifentanil levels.

TI.VA group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fondazione IRCCS Istituto Nazionale dei Tumori

Milan, 20133, Italy

Location

Related Publications (5)

  • Brown EN, Lydic R, Schiff ND. General anesthesia, sleep, and coma. N Engl J Med. 2010 Dec 30;363(27):2638-50. doi: 10.1056/NEJMra0808281. No abstract available.

    PMID: 21190458BACKGROUND

  • A.R. Absalom, MMRF Struys. Overview on Target Controlled Infusion and Total Intravenous Anaesthesia. 2Ed. Gent, Academia Press 2019.

    BACKGROUND

  • Absalom AR, De Keyser R, Struys MM. Closed loop anesthesia: are we getting close to finding the holy grail? Anesth Analg. 2011 Mar;112(3):516-8. doi: 10.1213/ANE.0b013e318203f5ad. No abstract available.

    PMID: 21350226BACKGROUND

  • Varvel JR, Donoho DL, Shafer SL. Measuring the predictive performance of computer-controlled infusion pumps. J Pharmacokinet Biopharm. 1992 Feb;20(1):63-94. doi: 10.1007/BF01143186.

    PMID: 1588504BACKGROUND

  • Tognoli E, Luigi M. Using the TI.VA algorithm to titrate the depth of general anaesthesia: a first-in-humans study. BJA Open. 2023 Jun 16;7:100203. doi: 10.1016/j.bjao.2023.100203. eCollection 2023 Sep.

    PMID: 37638086DERIVED

Study Officials

  • Emiliano Tognoli, MD

    Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: This is a prospective study involving a series of consecutive patients.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 21, 2021

First Posted

January 20, 2022

Study Start

December 1, 2020

Primary Completion

January 31, 2021

Study Completion

January 31, 2021

Last Updated

February 3, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will share

all IPD that underlie results in a publication

Shared Documents
CSR
Time Frame
Nov 2021
Access Criteria
free

Locations

IT(1)