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

University of Chile50 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Sedation Complication Covid19

Interventions

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Hospital Clinico de la Universidad de Chile

Santiago, RM, Chile

Outcomes

Primary Outcomes

Ventilator Free Days

Number of days in which the patient is both alive and out of the invasive mechanical ventilator

Time frame: Day 30

Secondary Outcomes

Plasma propofol concentration

Plasma propofol concentration measure with HPLC

Time frame: Day 5

Total administered dose of propofol

Accumulated Dose of propofol administered in mg/kg

Time frame: Day 5

Total administered dose of Fentanyl

Accumulated Dose of fentanyl administered in mcg/kg

Time frame: Day 5

Total administered dose of Norepinephrine

Accumulated Dose of norepinephrine administered in mcg/kg

Time frame: Day 5

Propofol-Related Infusion Syndrome (PRIS) Incidence

Diagnosis of PRIS

Time frame: Day 30

Accidental extubation

Occurrence of a non-planned extubation

Time frame: Day 30

Delirium Incidence

Diagnosis of delirium with CAM-ICU

Time frame: Day 30

ICU length of stay

Nights spent in the ICU

Time frame: Day 30

Hospital length of stay

Nights spent in the ICU

Time frame: Day 90

Mortality

Time frame: 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

Time frame: Day 30

Data from ClinicalTrials.gov

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