CompletedNot Applicable

Clinical Performance of the Automated Closed-loop Minimum Viable Prototype

Chile20 participantsStarted 2023-12-18

Plain-language 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

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Infusion rate of propofol

Timeframe: Fifth hour

Trial details

NCT IDNCT06187545

SponsorUniversity of Chile

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-06-30

View on ClinicalTrials.gov More Deep Sedation trials