Clinical Performance of the Automated Closed-loop Minimum Viable Prototype

NCT ID: NCT06187545

Last Updated: 2025-11-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-18
• Study Completion Date: 2025-08-30

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

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.

Conditions

Deep Sedation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Control group

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

Group Type: ACTIVE_COMPARATOR

Usual care

Intervention Type: DEVICE

Deep sedation without minimum viable prototype

Experimental group

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

Group Type: EXPERIMENTAL

Minimum viable prototype

Intervention Type: DEVICE

Deep sedation in critical ill patients using minimum viable prototype

Interventions

Minimum viable prototype

Deep sedation in critical ill patients using minimum viable prototype

Intervention Type: DEVICE

Usual care

Deep sedation without minimum viable prototype

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Chile

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hospital Base San José Osorno

Osorno, Los Lagos Region, Chile

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

Santiago, RM, Chile

Hospital Clinico de la Universidad de Chile

Santiago, RM, Chile

Countries

Chile

Other Identifiers

1219/21

Identifier Type: -

Identifier Source: org_study_id