Status:
COMPLETED
Clinical Performance of the Automated Closed-loop Minimum Viable Prototype
Lead Sponsor:
University of Chile
Conditions:
Deep Sedation
Eligibility:
All Genders
18-80 years
Phase:
NA
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...
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. Specifical...
Eligibility Criteria
Inclusion
- Indication of deep sedation for more than 48 hours
Exclusion
- 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
Key Trial Info
Start Date :
December 18 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 30 2025
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06187545
Start Date
December 18 2023
End Date
August 30 2025
Last Update
November 20 2025
Active Locations (3)
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1
Hospital Base San José Osorno
Osorno, Los Lagos Region, Chile
2
Centro de Investigación Cínica Avanzada (CICA), Hospital Clinico de la Universidad de Chile
Santiago, RM, Chile, 7690306
3
Hospital Clinico de la Universidad de Chile
Santiago, RM, Chile, 7690306