Automated closed-loop propofol administration for deep sedation in ICU patients
Official 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
Run by University of Chile · NCT06187545 · Data updated 2026-05-14
This study is no longer in our active list. It may have stopped recruiting or finished. The details below are as of 2026-05-14 and are kept for reference. Check ClinicalTrials.gov for its current status, or see similar studies below.
This study is testing a new automated system for giving propofol to ICU patients on ventilators to see if it can keep them deeply sedated with less medication than usual methods.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 80 Years |
| Sex | All |
| Enrollment | 20 (estimated) |
| Sponsor | University of Chile Academic / other |
| Locations | 3 sites (Osorno, Los Lagos and 2 other locations) |
| Trial ID | NCT06187545 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are patients requiring deep sedation for more than 48 hours in an ICU setting.
✕Probably not a fit
Patients with conditions such as dementia, cranial surgery, or those allergic to propofol may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial evaluates a minimum viable prototype designed for automated closed-loop administration of propofol in patients requiring deep sedation while on invasive mechanical ventilation in the ICU. Participants will experience both open-loop and closed-loop propofol administration in a randomized matched pair design over a 12-hour period. The study aims to determine if the automated system can maintain deep sedation effectively while minimizing the dosage of propofol compared to standard sedation practices.
Why it matters
Potential benefit: If successful, this approach could lead to safer and more efficient sedation practices in critically ill patients.
How similar studies have gone: While the concept of automated sedation has been explored, this specific prototype's effectiveness in a clinical setting remains novel and untested.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Hospital Base San José Osorno
Osorno, Los Lagos, Chile Recruiting -
Centro de Investigación Cínica Avanzada (CICA), Hospital Clinico de la Universidad de Chile
Santiago, Rm, Chile Not yet recruiting -
Hospital Clinico de la Universidad de Chile
Santiago, Rm, Chile Not yet recruiting
Study contacts
- Study coordinator: Antonello Penna, MD, PhD
- Email: apenna@uchile.cl
- Phone: +56229788209
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.