EEG-based Sedation Protocol for Patients on Mechanical Ventilation Due to SARS-CoV-2 Pneumonia

Study Overview
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Brief Summary
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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.

Official Title
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EEG-based Protocol to Guide Deep Sedation Decreases the Days of Mechanical Ventilation in Patients With SARS-CoV-2 Pneumonia: Randomized Clinical Trial

Conditions
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Sedation Complication, Covid19

Intervention / Treatment
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* Other: EEG based protocol for deep sedation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control (Usual care)<br>Sedation will be guided with a standard protocol based on Sedation Agitation Scale already implemented in the Intensive Care Unit | |
| Experimental: EEG-based sedation protocol<br>Sedation will be guided using a protocol based on 2 parameters from the EEG: Suppression Rate and Spectral Edge Frequency | Other: EEG based protocol for deep sedation<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ventilator Free Days | Number of days in which the patient is both alive and out of the invasive mechanical ventilator | Day 30 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma propofol concentration | Plasma propofol concentration measure with HPLC | Day 5 | 
| Total administered dose of propofol | Accumulated Dose of propofol administered in mg/kg | Day 5 | 
| Total administered dose of Fentanyl | Accumulated Dose of fentanyl administered in mcg/kg | Day 5 | 
| Total administered dose of Norepinephrine | Accumulated Dose of norepinephrine administered in mcg/kg | Day 5 | 
| Propofol-Related Infusion Syndrome (PRIS) Incidence | Diagnosis of PRIS | Day 30 | 
| Accidental extubation | Occurrence of a non-planned extubation | Day 30 | 
| Delirium Incidence | Diagnosis of delirium with CAM-ICU | Day 30 | 
| ICU length of stay | Nights spent in the ICU | Day 30 | 
| Hospital length of stay | Nights spent in the ICU | Day 90 | 
| Mortality | Mortality | Day 30 | 
| Success of the first weaning trial | Patients who succeed the first weaning trial and are extubated without difficulty, according to the WIND trial definition | Day 30 |