Clinical Performance of the Automated Closed-loop Minimum Viable Prototype

Clinical Performance of a Minimum Viable Prototype for Automated Closed-Loop Administration of Propofol for Deep Sedation in Patients on Invasive Mechanical Ventilation in Critically Ill Patient Units: a Pilot Randomized Clinical Trial

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

Study Overview

• Status: Completed
• Conditions: Deep Sedation
• Intervention / Treatment: Device: Usual care; Device: Minimum viable prototype

Detailed Description

The design of the study will consist of each patient being exposed to both forms of administration (matched pair study) during a 12-hour day (8:00 a.m. to 8:00 p.m.) in a randomized manner. Specifically, a patient will be given propofol infusion in open-loop mode in the first 5 hours (8:00 a.m. to 1:00 p.m.) and the next 5 hours in closed-loop mode (3:00 p.m. to 8:00 p.m.) with a wash-out period of 2 hours. The order will be randomly determined for each patient. This design will allow the use of the prototype to be evaluated under highly controlled conditions by a trained operator dedicated exclusively to this function.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Chile
  • Los Lagos Region
    • Osorno, Los Lagos Region, Chile
      • Hospital Base San José Osorno
  • RM
    • Santiago, RM, Chile, 7690306
      • Centro de Investigación Cínica Avanzada (CICA), Hospital Clinico de la Universidad de Chile
    • Santiago, RM, Chile, 7690306
      • Hospital Clinico de la Universidad de Chile

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Indication of deep sedation for more than 48 hours

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control group; 5-hour period in which patients will continue to be routinely sedated in the critical care unit	Device: Usual care; Deep sedation without minimum viable prototype
Experimental: Experimental group; 5-hour period in which patients will be sedated through the closed-loop system	Device: Minimum viable prototype; Deep sedation in critical ill patients using minimum viable prototype

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Infusion rate of propofol	mg/kg/h	Fifth hour

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total dose of propofol	mg	Five hours
Norepinephrine infusion rate	mcg/kg/min	fifth hour
Sedation level	Scale SAS (Sedation-Agitation Scale, Score 1-7) (1-2 deeply sedated, 3-4 sedated or calm, 5-6 agitated, and 7 dangerously agitated)	Fifth hour
BIS level	BIS index (bispectral index, values from 0-100, 0 is the minimum, which indicates isoelectric electroencephalographic activity and 100 is the maximun, which indicates awake electroencephalographic activity)	Five hours
Suppression rate	Percentage	Five hours

Collaborators and Investigators

• Sponsor: University of Chile

Study record dates

Study Major Dates

• Study Start (Actual): December 18, 2023
• Primary Completion (Actual): June 30, 2025
• Study Completion (Actual): August 30, 2025

Study Registration Dates

• First Submitted: December 15, 2023
• First Submitted That Met QC Criteria: December 15, 2023
• First Posted (Actual): January 2, 2024

Study Record Updates

• Last Update Posted (Actual): November 20, 2025
• Last Update Submitted That Met QC Criteria: November 17, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 1219/21

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No