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

Primary Purpose

Sedation Complication, Covid19

Status
Completed
Phase
Not Applicable
Locations
Chile
Study Type
Interventional
Intervention
EEG based protocol for deep sedation
Sponsored by
University of Chile
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sedation Complication

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital Clinico de la Universidad de Chile

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control (Usual care)

EEG-based sedation protocol

Arm Description

Sedation will be guided with a standard protocol based on Sedation Agitation Scale already implemented in the Intensive Care Unit

Sedation will be guided using a protocol based on 2 parameters from the EEG: Suppression Rate and Spectral Edge Frequency

Outcomes

Primary Outcome Measures

Ventilator Free Days
Number of days in which the patient is both alive and out of the invasive mechanical ventilator

Secondary Outcome Measures

Plasma propofol concentration
Plasma propofol concentration measure with HPLC
Total administered dose of propofol
Accumulated Dose of propofol administered in mg/kg
Total administered dose of Fentanyl
Accumulated Dose of fentanyl administered in mcg/kg
Total administered dose of Norepinephrine
Accumulated Dose of norepinephrine administered in mcg/kg
Propofol-Related Infusion Syndrome (PRIS) Incidence
Diagnosis of PRIS
Accidental extubation
Occurrence of a non-planned extubation
Delirium Incidence
Diagnosis of delirium with CAM-ICU
ICU length of stay
Nights spent in the ICU
Hospital length of stay
Nights spent in the ICU
Mortality
Mortality
Success of the first weaning trial
Patients who succeed the first weaning trial and are extubated without difficulty, according to the WIND trial definition

Full Information

First Posted
January 6, 2021
Last Updated
September 23, 2021
Sponsor
University of Chile
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1. Study Identification

Unique Protocol Identification Number
NCT04699916
Brief Title
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

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
January 4, 2021 (Actual)
Primary Completion Date
May 23, 2021 (Actual)
Study Completion Date
September 23, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Chile

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sedation Complication, Covid19

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control (Usual care)
Arm Type
No Intervention
Arm Description
Sedation will be guided with a standard protocol based on Sedation Agitation Scale already implemented in the Intensive Care Unit
Arm Title
EEG-based sedation protocol
Arm Type
Experimental
Arm Description
Sedation will be guided using a protocol based on 2 parameters from the EEG: Suppression Rate and Spectral Edge Frequency
Intervention Type
Other
Intervention Name(s)
EEG based protocol for deep sedation
Intervention Description
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
Primary Outcome Measure Information:
Title
Ventilator Free Days
Description
Number of days in which the patient is both alive and out of the invasive mechanical ventilator
Time Frame
Day 30
Secondary Outcome Measure Information:
Title
Plasma propofol concentration
Description
Plasma propofol concentration measure with HPLC
Time Frame
Day 5
Title
Total administered dose of propofol
Description
Accumulated Dose of propofol administered in mg/kg
Time Frame
Day 5
Title
Total administered dose of Fentanyl
Description
Accumulated Dose of fentanyl administered in mcg/kg
Time Frame
Day 5
Title
Total administered dose of Norepinephrine
Description
Accumulated Dose of norepinephrine administered in mcg/kg
Time Frame
Day 5
Title
Propofol-Related Infusion Syndrome (PRIS) Incidence
Description
Diagnosis of PRIS
Time Frame
Day 30
Title
Accidental extubation
Description
Occurrence of a non-planned extubation
Time Frame
Day 30
Title
Delirium Incidence
Description
Diagnosis of delirium with CAM-ICU
Time Frame
Day 30
Title
ICU length of stay
Description
Nights spent in the ICU
Time Frame
Day 30
Title
Hospital length of stay
Description
Nights spent in the ICU
Time Frame
Day 90
Title
Mortality
Description
Mortality
Time Frame
Day 30
Title
Success of the first weaning trial
Description
Patients who succeed the first weaning trial and are extubated without difficulty, according to the WIND trial definition
Time Frame
Day 30

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Hospital Clinico de la Universidad de Chile
City
Santiago
State/Province
RM
ZIP/Postal Code
7563215
Country
Chile

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32227758
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.
Results Reference
background
PubMed Identifier
9726743
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.
Results Reference
background
PubMed Identifier
32392023
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.
Results Reference
background
PubMed Identifier
28786839
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.
Results Reference
background
PubMed Identifier
11902253
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. Erratum In: Crit Care Med 2002 Mar;30(3):726.
Results Reference
background

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

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