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

Not Applicable

Completed

• Conditions: Sedation Complication; Covid19
• Interventions: Other: EEG based protocol for deep sedation

• Registration Number: NCT04699916
• Lead Sponsor: University of Chile

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-01-04
• Study First Submitted: 2021-01-06
• Study First Submitted QC: 2021-01-06
• Study First Posted: 2021-01-07
• Primary Completion: 2021-05-23
• Status Verified: 2021-09
• Study Completion: 2021-09-23
• Last Update Submitted: 2021-09-23
• Last Update Posted: 2021-09-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
EEG-based sedation protocol	EEG based protocol for deep sedation	Sedation will be guided using a protocol based on 2 parameters from the EEG: Suppression Rate and Spectral Edge Frequency

Primary Outcome Measures

Name	Time	Method
Ventilator Free Days	Day 30	Number of days in which the patient is both alive and out of the invasive mechanical ventilator

Secondary Outcome Measures

Name	Time	Method
Total administered dose of propofol	Day 5	Accumulated Dose of propofol administered in mg/kg
Delirium Incidence	Day 30	Diagnosis of delirium with CAM-ICU
Plasma propofol concentration	Day 5	Plasma propofol concentration measure with HPLC
Total administered dose of Fentanyl	Day 5	Accumulated Dose of fentanyl 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
Hospital length of stay	Day 90	Nights spent in the ICU
Total administered dose of Norepinephrine	Day 5	Accumulated Dose of norepinephrine administered in mcg/kg
Mortality	Day 30	Mortality
ICU length of stay	Day 30	Nights spent in the ICU
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

Trial Locations

Locations (1)

Hospital Clinico de la Universidad de Chile; 🇨🇱 Santiago, RM, Chile