Clinical Performance of the Automated Closed-loop Minimum Viable Prototype

NCT06187545 | Completed

• 1 other identifier: 1219/21
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 3

Brief Summary

The goal of this clinical trial is to evaluate a minimum viable prototype for automated closed-loop administration of propofol in deep sedated patients under invasive mechanical ventilation in the ICU. The main question it aims to answer is: • whether the minimum viable prototype for automated closed-loop administration of propofol is effective in keeping patients in deep sedation using the lowest possible dose of propofol Participants will undergo deep sedation using the minimum viable prototype for automated closed-loop propofol administration. The usual practice of sedation will be compared with the practice of sedating with the minimum viable prototype to see if the infusion rate of propofol is decreased

Conditions

Deep Sedation

Outcome Measures

Primary Outcomes (1)

• Infusion rate of propofol

  mg/kg/h

  Fifth hour

Secondary Outcomes (5)

• Sedation level

  Fifth hour

• Total dose of propofol

  Five hours

• BIS level

  Five hours

• Suppression rate

  Five hours

• Norepinephrine infusion rate

  fifth hour

Study Arms (2)

Control group

ACTIVE COMPARATOR

5-hour period in which patients will continue to be routinely sedated in the critical care unit

Device: Usual care

Experimental group

EXPERIMENTAL

5-hour period in which patients will be sedated through the closed-loop system

Device: Minimum viable prototype

Interventions

Minimum viable prototype DEVICE

Deep sedation in critical ill patients using minimum viable prototype

Experimental group

Usual care DEVICE

Deep sedation without minimum viable prototype

Control group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Indication of deep sedation for more than 48 hours

You may not qualify if:

• Dementia
• Cranial surgery
• Hypoxic-ischemic encephalopathy
• Chronic liver damage Child C
• History of substance and drug abuse that can alter EEG recordings or the metabolization of drugs (antipsychotics, cocaine, benzodiazepines, opioids)
• Pregnant women
• allergic to propofol
• EEG sensor of the BIS® Covidien cannot be installed

Sponsors & Collaborators

• University of Chile: lead

Study Sites (3)

Hospital Base San José Osorno

Osorno, Los Lagos Region, Chile

Location

Centro de Investigación Cínica Avanzada (CICA), Hospital Clinico de la Universidad de Chile

Santiago, RM, 7690306, Chile

Location

Hospital Clinico de la Universidad de Chile

Santiago, RM, 7690306, Chile

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2023
• First Posted: January 2, 2024
• Study Start: December 18, 2023
• Primary Completion: June 30, 2025
• Study Completion: August 30, 2025
• Last Updated: November 20, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

CL (3)