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

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ClinicalTrials.gov Identifier: NCT04699916

Recruitment Status : Completed

First Posted : January 7, 2021

Last Update Posted : September 24, 2021

Sponsor:

Information provided by (Responsible Party):

Rodrigo Gutiérrez, University of Chile

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Sedation Complication Covid19	Other: EEG based protocol for deep sedation	Not Applicable

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	50 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Double (Participant, Outcomes Assessor)
Primary Purpose:	Treatment
Official Title:	EEG-based Protocol to Guide Deep Sedation Decreases the Days of Mechanical Ventilation in Patients With SARS-CoV-2 Pneumonia: Randomized Clinical Trial
Actual Study Start Date :	January 4, 2021
Actual Primary Completion Date :	May 23, 2021
Actual Study Completion Date :	September 23, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COVID-19 (Coronavirus Disease 2019) Pneumonia

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
No Intervention: Control (Usual care) 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 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 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

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

Plasma propofol concentration [ Time Frame: Day 5 ]
Plasma propofol concentration measure with HPLC
Total administered dose of propofol [ Time Frame: Day 5 ]
Accumulated Dose of propofol administered in mg/kg
Total administered dose of Fentanyl [ Time Frame: Day 5 ]
Accumulated Dose of fentanyl administered in mcg/kg
Total administered dose of Norepinephrine [ Time Frame: Day 5 ]
Accumulated Dose of norepinephrine administered in mcg/kg
Propofol-Related Infusion Syndrome (PRIS) Incidence [ Time Frame: Day 30 ]
Diagnosis of PRIS
Accidental extubation [ Time Frame: Day 30 ]
Occurrence of a non-planned extubation
Delirium Incidence [ Time Frame: Day 30 ]
Diagnosis of delirium with CAM-ICU
ICU length of stay [ Time Frame: Day 30 ]
Nights spent in the ICU
Hospital length of stay [ Time Frame: Day 90 ]
Nights spent in the ICU
Mortality [ Time Frame: Day 30 ]
Mortality
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

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04699916

Locations

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Chile
Hospital Clinico de la Universidad de Chile
Santiago, RM, Chile, 7563215

Sponsors and Collaborators

University of Chile

More Information

Publications:

Bhatraju PK, Ghassemieh BJ, Nichols M, Kim R, Jerome KR, Nalla AK, Greninger AL, Pipavath S, Wurfel MM, Evans L, Kritek PA, West TE, Luks A, Gerbino A, Dale CR, Goldman JD, O'Mahony S, Mikacenic C. Covid-19 in Critically Ill Patients in the Seattle Region - Case Series. N Engl J Med. 2020 May 21;382(21):2012-2022. doi: 10.1056/NEJMoa2004500. Epub 2020 Mar 30.

Kollef MH, Levy NT, Ahrens TS, Schaiff R, Prentice D, Sherman G. The use of continuous i.v. sedation is associated with prolongation of mechanical ventilation. Chest. 1998 Aug;114(2):541-8.

Hanidziar D, Bittner EA. Sedation of Mechanically Ventilated COVID-19 Patients: Challenges and Special Considerations. Anesth Analg. 2020 Jul;131(1):e40-e41. doi: 10.1213/ANE.0000000000004887.

Fahy BG, Chau DF. The Technology of Processed Electroencephalogram Monitoring Devices for Assessment of Depth of Anesthesia. Anesth Analg. 2018 Jan;126(1):111-117. doi: 10.1213/ANE.0000000000002331. Review.

Jacobi J, Fraser GL, Coursin DB, Riker RR, Fontaine D, Wittbrodt ET, Chalfin DB, Masica MF, Bjerke HS, Coplin WM, Crippen DW, Fuchs BD, Kelleher RM, Marik PE, Nasraway SA Jr, Murray MJ, Peruzzi WT, Lumb PD; Task Force of the American College of Critical Care Medicine (ACCM) of the Society of Critical Care Medicine (SCCM), American Society of Health-System Pharmacists (ASHP), American College of Chest Physicians. Clinical practice guidelines for the sustained use of sedatives and analgesics in the critically ill adult. Crit Care Med. 2002 Jan;30(1):119-41. Erratum in: Crit Care Med 2002 Mar;30(3):726.

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Responsible Party:	Rodrigo Gutiérrez, Assistant Professor, University of Chile
ClinicalTrials.gov Identifier:	NCT04699916
Other Study ID Numbers:	80320
First Posted:	January 7, 2021 Key Record Dates
Last Update Posted:	September 24, 2021
Last Verified:	September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

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Studies a U.S. FDA-regulated Drug Product:	No
Studies a U.S. FDA-regulated Device Product:	No

Additional relevant MeSH terms:

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Pneumonia Respiratory Tract Infections Infections Lung Diseases Respiratory Tract Diseases

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