Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | Active Comparator | 5-hour period in which patients will continue to be routinely sedated in the critical care unit |
|
| Experimental group | Experimental | 5-hour period in which patients will be sedated through the closed-loop system |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Minimum viable prototype | Device | Deep sedation in critical ill patients using minimum viable prototype |
|
| Measure | Description | Time Frame |
|---|---|---|
| Infusion rate of propofol | mg/kg/h | Fifth hour |
| Measure | Description | Time Frame |
|---|---|---|
| Sedation level | Scale SAS (Sedation-Agitation Scale, Score 1-7) (1-2 deeply sedated, 3-4 sedated or calm, 5-6 agitated, and 7 dangerously agitated) | Fifth hour |
| Total dose of propofol | mg |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Base San José Osorno | Osorno | Los Lagos Region | Chile | |||
| Centro de Investigación Cínica Avanzada (CICA), Hospital Clinico de la Universidad de Chile |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Usual care | Device | Deep sedation without minimum viable prototype |
|
| Five hours |
| BIS level | 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) | Five hours |
| Suppression rate | Percentage | Five hours |
| Norepinephrine infusion rate | mcg/kg/min | fifth hour |
| Santiago |
| RM |
| 7690306 |
| Chile |
| Hospital Clinico de la Universidad de Chile | Santiago | RM | 7690306 | Chile |