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

Covid19 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04699916
• Other study ID #: 80320
• Status: Completed
• Phase: N/A
• Start date: January 4, 2021
• Est. completion date: September 23, 2021

Study information

• Verified date: September 2021
• Source: University of Chile
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: September 23, 2021
• Est. primary completion date: May 23, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Covid19
• Pneumonia
• Sedation Complication

Intervention

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

Locations

Country	Name	City	State
Chile	Hospital Clinico de la Universidad de Chile	Santiago	RM

Sponsors (1)

Lead Sponsor	Collaborator
University of Chile

Country where clinical trial is conducted

Chile, 

References & 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. — View 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. Review. — View 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. — View 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. Erratum in: Crit Care Med 2002 Mar;30(3):726. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ventilator Free Days	Number of days in which the patient is both alive and out of the invasive mechanical ventilator	Day 30
Secondary	Plasma propofol concentration	Plasma propofol concentration measure with HPLC	Day 5
Secondary	Total administered dose of propofol	Accumulated Dose of propofol administered in mg/kg	Day 5
Secondary	Total administered dose of Fentanyl	Accumulated Dose of fentanyl administered in mcg/kg	Day 5
Secondary	Total administered dose of Norepinephrine	Accumulated Dose of norepinephrine administered in mcg/kg	Day 5
Secondary	Propofol-Related Infusion Syndrome (PRIS) Incidence	Diagnosis of PRIS	Day 30
Secondary	Accidental extubation	Occurrence of a non-planned extubation	Day 30
Secondary	Delirium Incidence	Diagnosis of delirium with CAM-ICU	Day 30
Secondary	ICU length of stay	Nights spent in the ICU	Day 30
Secondary	Hospital length of stay	Nights spent in the ICU	Day 90
Secondary	Mortality	Mortality	Day 30
Secondary	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