Deep Sedation
Conditions
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. 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
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. 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.
Interventions
DEVICEMinimum viable prototype
Deep sedation in critical ill patients using minimum viable prototype
DEVICEUsual care
Deep sedation without minimum viable prototype
Sponsors
University of Chile
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Infusion rate of propofol | Fifth hour | mg/kg/h |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sedation level | 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) |
| Total dose of propofol | Five hours | mg |
| BIS level | 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) |
| Suppression rate | Five hours | Percentage |
| Norepinephrine infusion rate | fifth hour | mcg/kg/min |
Countries
Chile
Outcome results
None listed