Clinical trial NCT04699916: EEG-based Sedation Protocol for Patients on Mechanical Ventilation Due to SARS-CoV-2 Pneumonia
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sedation Complication
Covid19
Lead sponsor: University of Chile
Sponsor class: OTHER
First posted: 2021-01-07
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Ventilator Free Days
timeFrame: Day 30
Secondary outcomes:
measure: Plasma propofol concentration
timeFrame: Day 5
measure: Total administered dose of propofol
timeFrame: Day 5
measure: Total administered dose of Fentanyl
timeFrame: Day 5
measure: Total administered dose of Norepinephrine
timeFrame: Day 5
measure: Propofol-Related Infusion Syndrome (PRIS) Incidence
timeFrame: Day 30
measure: Accidental extubation
timeFrame: Day 30
measure: Delirium Incidence
timeFrame: Day 30
measure: ICU length of stay
timeFrame: Day 30
measure: Hospital length of stay
timeFrame: Day 90
measure: Mortality
timeFrame: Day 30
measure: Success of the first weaning trial
timeFrame: Day 30
Other outcomes:
Locations:
city: Santiago
country: Chile
facility: Hospital Clinico de la Universidad de Chile
state: RM
Study officials:
References:
citation: 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.
citation: 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. doi: 10.1378/chest.114.2.541.
citation: 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. No abstract available.
citation: 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.
citation: 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. doi: 10.1097/00003246-200201000-00020. No abstract available.