EEG-based Sedation Protocol for Patients on Mechanical Ventilation Due to SARS-CoV-2 Pneumonia
EEG-based Protocol to Guide Deep Sedation Decreases the Days of Mechanical Ventilation in Patients With SARS-CoV-2 Pneumonia: Randomized Clinical Trial
1 other identifier
interventional
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2021
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 4, 2021
CompletedFirst Submitted
Initial submission to the registry
January 6, 2021
CompletedFirst Posted
Study publicly available on registry
January 7, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 23, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
September 23, 2021
CompletedSeptember 24, 2021
September 1, 2021
5 months
January 6, 2021
September 23, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Ventilator Free Days
Number of days in which the patient is both alive and out of the invasive mechanical ventilator
Day 30
Secondary Outcomes (11)
Plasma propofol concentration
Day 5
Total administered dose of propofol
Day 5
Total administered dose of Fentanyl
Day 5
Total administered dose of Norepinephrine
Day 5
Propofol-Related Infusion Syndrome (PRIS) Incidence
Day 30
- +6 more secondary outcomes
Study Arms (2)
Control (Usual care)
NO INTERVENTIONSedation will be guided with a standard protocol based on Sedation Agitation Scale already implemented in the Intensive Care Unit
EEG-based sedation protocol
EXPERIMENTALSedation will be guided using a protocol based on 2 parameters from the EEG: Suppression Rate and Spectral Edge Frequency
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 Criteria
You may qualify if:
- Patients over 18 years old
- COVID-19 patient requiring mechanical ventilation
You may not qualify if:
- Contraindication to receive propofol or fentanyl
- Chronic Liver Disease Child C
- End-Stage Kidney Chronic Disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital Clinico de la Universidad de Chile
Santiago, RM, 7563215, Chile
Related Publications (5)
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.
PMID: 32227758BACKGROUNDKollef 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. doi: 10.1378/chest.114.2.541.
PMID: 9726743BACKGROUNDHanidziar 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. No abstract available.
PMID: 32392023BACKGROUNDFahy 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.
PMID: 28786839BACKGROUNDJacobi 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. doi: 10.1097/00003246-200201000-00020. No abstract available.
PMID: 11902253BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
January 6, 2021
First Posted
January 7, 2021
Study Start
January 4, 2021
Primary Completion
May 23, 2021
Study Completion
September 23, 2021
Last Updated
September 24, 2021
Record last verified: 2021-09
Data Sharing
- IPD Sharing
- Will not share