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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control (Usual care) | No Intervention | Sedation will be guided with a standard protocol based on Sedation Agitation Scale already implemented in the Intensive Care Unit | |
| EEG-based sedation protocol | Experimental | Sedation will be guided using a protocol based on 2 parameters from the EEG: Suppression Rate and Spectral Edge Frequency |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Ventilator Free Days | Number of days in which the patient is both alive and out of the invasive mechanical ventilator | Day 30 |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma propofol concentration | Plasma propofol concentration measure with HPLC | Day 5 |
| Total administered dose of propofol | Accumulated Dose of propofol administered in mg/kg |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Clinico de la Universidad de Chile | Santiago | RM | 7563215 | Chile |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32227758 | Background | 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. | |
| 9726743 |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D054810 | Deep Sedation |
| ID | Term |
|---|---|
| D000760 | Anesthesia and Analgesia |
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| Day 5 |
| Total administered dose of Fentanyl | Accumulated Dose of fentanyl administered in mcg/kg | Day 5 |
| Total administered dose of Norepinephrine | Accumulated Dose of norepinephrine administered in mcg/kg | Day 5 |
| Propofol-Related Infusion Syndrome (PRIS) Incidence | Diagnosis of PRIS | Day 30 |
| Accidental extubation | Occurrence of a non-planned extubation | Day 30 |
| Delirium Incidence | Diagnosis of delirium with CAM-ICU | Day 30 |
| ICU length of stay | Nights spent in the ICU | Day 30 |
| Hospital length of stay | Nights spent in the ICU | Day 90 |
| Mortality | Mortality | Day 30 |
| Success of the first weaning trial | Patients who succeed the first weaning trial and are extubated without difficulty, according to the WIND trial definition | Day 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. doi: 10.1378/chest.114.2.541. |
| 32392023 | Background | 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. |
| 28786839 | Background | 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. |
| 11902253 | Background | 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. |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |