Automated closed-loop propofol administration for deep sedation in ICU patients
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
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | University of Chile Academic / other |
| Locations | 3 sites (Osorno, Los Lagos and 2 other locations) |
| Trial ID | NCT06187545 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are patients requiring deep sedation for more than 48 hours in an ICU setting.
Not a fit: Patients with conditions such as dementia, cranial surgery, or those allergic to propofol may not benefit from this study.
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 performed: While the concept of automated sedation has been explored, this specific prototype's effectiveness in a clinical setting remains novel and untested.
Eligibility criteria
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 this trial is running
Osorno, Los Lagos and 2 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.