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Completed

NCT Number: NCT06187545

Clinical Performance of the Automated Closed-loop Minimum Viable Prototype

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

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Key information

Conditions

Deep Sedation

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Base San José Osorno, Osorno, Los Lagos Region, Chile

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Minimum viable prototype

Device

Deep sedation in critical ill patients using minimum viable prototype

Usual Care

Device

Deep sedation without minimum viable prototype

Primary outcomes

  1. Infusion rate of propofol

    Time frame: Fifth hour

    mg/kg/h

Secondary outcomes

  1. Sedation level

    Time frame: Fifth hour

    Scale SAS (Sedation-Agitation Scale, Score 1-7) (1-2 deeply sedated, 3-4 sedated or calm, 5-6 agitated, and 7 dangerously agitated)

  2. Total dose of propofol

    Time frame: Five hours

    mg

  3. BIS level

    Time frame: Five hours

    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)

  4. Suppression rate

    Time frame: Five hours

    Percentage

  5. Norepinephrine infusion rate

    Time frame: fifth hour

    mcg/kg/min

Sponsors and collaborators

Lead sponsor

University of Chile

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jan 2, 2024
Registry last updated
Nov 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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