Automatic Control of Total Intravenous Anesthesia (ACTIVA)

NCT04432974 | Completed Results DMC

• 1 other identifier: NP-2861
• Study Type: interventional
• Target: 139
• Locations: 1 country
• Sites: 1

Brief Summary

This study concerns the clinical evaluation of a closed loop control system for the automatic administration of anesthetic drugs in TIVA (Total Intra Venous Anesthesia). The purpose of the experimentation is to demonstrate that the control system under study is reliable, safe, applicable and capable of inducing and maintaining an optimal anesthetic level.

Conditions

Anesthesia

Keywords

Closed-loop Anesthesia; PID Control; Medical Control Systems; Automated Drug Delivery; Propofol; Remifentanil; Bispectral index; BIS

Outcome Measures

Primary Outcomes (1)

• Depth of Hypnosis Adequacy

  The depth of hypnosis adequacy is assessed by evaluating, for each patient enrolled, the percentage of maintenance duration during which the Bispectral Index Scale (BIS) is kept within the recommended range from 40 to 60 (BIS \[40,60\]). The outcome measure is defined as the median of these percentages calculated over all the patients enrolled in the study. The median of the percentages, calculated over all the patients enrolled in the study, of the anesthesia maintenance duration in which the BIS is kept below 40 (BIS\<40) is also specified. Maintenance duration is the period of time that goes from the end of anesthesia induction to the point at which the automatic control is turned off at the conclusion of surgery. The end of anesthesia induction is defined as the time instant when the BIS drops below 60 for the first time and remains there for the subsequent 30 seconds. The BIS ranges from 0 (absence of brain activity) to 100 (fully awake patient).

  During anesthesia from the time instant when the BIS drops below 60 for the first time and remains there for the subsequent 30 seconds to the point at which the automatic control is turned off (maintenance duration), an average of 2 hours.

Secondary Outcomes (9)

• Number of Participants for Which the System Showed Dysfunctions

  During anesthesia from the time instant when the automatic control is started to the point at which the automatic control is turned off at the conclusion of surgery, an average of 2 hours.

• Levels of Satisfaction of the Experimenter Expressed as Number of Participants Who Have Received a Specific Score

  During anesthesia from the time instant when the automatic control is started to the point at which the automatic control is turned off at the conclusion of surgery, an average of 2 hours.

• Effect of Drugs Delivery on Heart Rate

  During anesthesia from the time instant when the BIS drops below 60 for the first time and remains there for the subsequent 30 seconds to the point at which the automatic control is turned off (maintenance duration), an average of 2 hours.

• Effect of Drugs Delivery on Mean Arterial Pressure (MAP)

  During anesthesia from the time instant when the BIS drops below 60 for the first time and remains there for the subsequent 30 seconds to the point at which the automatic control is turned off (maintenance duration), an average of 2 hours.

• Postoperative Heart Rate Stability

  End of anesthesia (operating room discharge, recovery room admission, recovery room discharge), 6 hours after surgery, 24 hours after surgery.

Study Arms (1)

ACTIVA

EXPERIMENTAL

ACTIVA closed-loop anesthesia control system

Device: Automatic closed-loop anesthesia

Interventions

Automatic closed-loop anesthesia DEVICE

Total intravenous anesthesia performed with the ACTIVA automatic control system

Also known as: ACTIVA

ACTIVA

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients undergoing total intravenous general anesthesia for elective surgery

You may not qualify if:

• Patients under the age of 18
• Patients incapable of giving consent

Sponsors & Collaborators

• Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia: lead
• Università degli Studi di Brescia: collaborator

Study Sites (1)

Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

Brescia, 25123, Italy

Location

Related Publications (3)

• Padula F, Ionescu C, Latronico N, Paltenghi M, Visioli A, Vivacqua G. Optimized PID control of depth of hypnosis in anesthesia. Comput Methods Programs Biomed. 2017 Jun;144:21-35. doi: 10.1016/j.cmpb.2017.03.013. Epub 2017 Mar 18.

  PMID: 28495004 BACKGROUND

• Merigo L, Beschi M, Padula F, Latronico N, Paltenghi M, Visioli A. Event-Based control of depth of hypnosis in anesthesia. Comput Methods Programs Biomed. 2017 Aug;147:63-83. doi: 10.1016/j.cmpb.2017.06.007. Epub 2017 Jun 23.

  PMID: 28734531 BACKGROUND

• Schiavo M, Paltenghi M, Visioli A, Latronico N. Clinical Performance of a Bispectral Index Controlled Closed-Loop Administration System for Simultaneous Administration of Propofol and Remifentanil. Anesth Analg. 2025 May 1;140(5):1236-1238. doi: 10.1213/ANE.0000000000007289. No abstract available.

  PMID: 39413036 DERIVED

Results Point of Contact

• Title: Dr. Massimiliano Paltenghi
• Organization: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

massimiliano.paltenghi@spedalicivili.brescia.it

(+39) 3487046844

Study Officials

• Massimiliano Paltenghi, MD

  Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 9, 2020
• First Posted: June 16, 2020
• Study Start: July 2, 2019
• Primary Completion: April 4, 2023
• Study Completion: April 4, 2023
• Last Updated: October 4, 2024
• Results First Posted: October 4, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)