Covid19, Sedation Complication
Conditions
Brief summary
Deep sedation in patients with COVID-19 may be challenging in many aspects. The use of an EEG-based protocol to guide deep sedation may be useful in this particular population, considering their unusually high sedation requirements. In the present trial, we aim to evaluate an EEG-based protocol to guide deep sedation in patients with COVID19, using to EEG derived parameters that are displayed in the BIS monitor: Suppression Rate and Spectral Edge Frequency. The protocol is designed to both minimize the suppression rate along with maintaining a spectral edge frequency over 10 Hz. The use of this protocol may reduce the amount of sedatives administered and, therefore, diminish the time needed for the weaning process.
Interventions
OTHEREEG based protocol for deep sedation
Protocol established to guide sedation drug dosification to maintain the patient with a Suppression Rate (SR) less than 1% and a Spectral Edge Frequency 95 over 10 Hz
Sponsors
University of Chile
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients over 18 years old * COVID-19 patient requiring mechanical ventilation
Exclusion criteria
* Contraindication to receive propofol or fentanyl * Chronic Liver Disease Child C * End-Stage Kidney Chronic Disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ventilator Free Days | Day 30 | Number of days in which the patient is both alive and out of the invasive mechanical ventilator |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total administered dose of propofol | Day 5 | Accumulated Dose of propofol administered in mg/kg |
| Total administered dose of Fentanyl | Day 5 | Accumulated Dose of fentanyl administered in mcg/kg |
| Total administered dose of Norepinephrine | Day 5 | Accumulated Dose of norepinephrine administered in mcg/kg |
| Propofol-Related Infusion Syndrome (PRIS) Incidence | Day 30 | Diagnosis of PRIS |
| Accidental extubation | Day 30 | Occurrence of a non-planned extubation |
| Plasma propofol concentration | Day 5 | Plasma propofol concentration measure with HPLC |
| ICU length of stay | Day 30 | Nights spent in the ICU |
| Hospital length of stay | Day 90 | Nights spent in the ICU |
| Mortality | Day 30 | Mortality |
| Success of the first weaning trial | Day 30 | Patients who succeed the first weaning trial and are extubated without difficulty, according to the WIND trial definition |
| Delirium Incidence | Day 30 | Diagnosis of delirium with CAM-ICU |
Countries
Chile
Outcome results
None listed