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Completed

NCT Number: NCT04699916

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

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.

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Key information

Conditions

Sedation Complication COVID-19 Coronaviridae Infections Coronavirus Infections Covid19 Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Clinico de la Universidad de Chile

Santiago, RM, 7563215, Chile

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

EEG based protocol for deep sedation

Other

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

Primary outcomes

  1. Ventilator Free Days

    Time frame: Day 30

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

Secondary outcomes

  1. Plasma propofol concentration

    Time frame: Day 5

    Plasma propofol concentration measure with HPLC

  2. Total administered dose of propofol

    Time frame: Day 5

    Accumulated Dose of propofol administered in mg/kg

  3. Total administered dose of Fentanyl

    Time frame: Day 5

    Accumulated Dose of fentanyl administered in mcg/kg

  4. Total administered dose of Norepinephrine

    Time frame: Day 5

    Accumulated Dose of norepinephrine administered in mcg/kg

  5. Propofol-Related Infusion Syndrome (PRIS) Incidence

    Time frame: Day 30

    Diagnosis of PRIS

  6. Accidental extubation

    Time frame: Day 30

    Occurrence of a non-planned extubation

  7. Delirium Incidence

    Time frame: Day 30

    Diagnosis of delirium with CAM-ICU

  8. ICU length of stay

    Time frame: Day 30

    Nights spent in the ICU

  9. Hospital length of stay

    Time frame: Day 90

    Nights spent in the ICU

  10. Mortality

    Time frame: Day 30

    Mortality

  11. Success of the first weaning trial

    Time frame: Day 30

    Patients who succeed the first weaning trial and are extubated without difficulty, according to the WIND trial definition

Sponsors and collaborators

Lead sponsor

University of Chile

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jan 7, 2021
Registry last updated
Sep 24, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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