Prospective Electroencephalography Evaluation of Sedation in COVID-19

Study Overview
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Brief Summary
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Sedation of severe COVID-19 disease are often complicated. We try to find a correlate for this observation by encephalographic studies.

Detailed Description
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Sedation of critically ill ventilated coronavirus patients, continues to be a challenging issue. Also, neurological symptoms of severe COVID-19 disease have been described frequently. Difficulties in sedation of these patients have been discussed repeatedly. The aim of this study is to investigate whether an encephalographic correlate can be found. Appropriate processed encephalographic techniques have been used for anesthesia monitoring for many years. The aim of our study is to collect unrelated processed and raw EEG data of sedated COVID-19 patients and to investigate the correlation to the necessary sedation.

Official Title
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Prospective Evaluation of Aggravated Sedation in COVID-19 ARDS Patients Using Electroencephalography

Conditions
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Conscious Sedation, Pathologic Processes, Electroencephalogram, Acute Respiratory Distress Syndrome, Corona Virus Infection

Intervention / Treatment
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* Other: Encephalography measurement


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Intubated ventilated patients with SARS-CoV-2 associated acute respiratory distress syndrome and sedation difficulty. Exclusion Criteria: Pre-existing severe cerebral brain damage and dysfunction. For example: previous medial infarction, cerebral hemorrhage, structural epilepsy.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| critical ill COVID-19<br>Critically ill COVID-19 patients with need for ventilation and appropriate sedation | Other: Encephalography measurement<br>* Encephalography measurement and partially aggravated sedation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Raw data encephalography measurement | Measurement of the brain activity detectable for the examination procedure in the surface encephalogram. | From the beginning of the measurement until the end of the examination (10 to 20 minutes). | 
| Processed encephalography measurement | Measurement of detectable algorithm based patient sedation score based on brain activity in the surface encephalogram. | From the beginning of the measurement until the end of the examination (10 to 20 minutes). | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dosage of continuously administered centrally acting alpha2 agonists. | Sedative dosage continuously administered during the measurement interval. [µg/kg/h] | From 90 minutes before to 10 minutes after encephalographic measurement | 
| Dosage of continuously delivered central GABA receptor active substances. | Sedative dosage continuously administered during the measurement interval. [mg/kg/h] | From 90 minutes before to 10 minutes after encephalographic measurement | 
| Dosage of continuously delivered central NMDA receptor active substances. | Sedative dosage continuously administered during the measurement interval. [mg/kg/h] | From 90 minutes before to 10 minutes after encephalographic measurement | 
| Dosage of continuously delivered opioid based analgesia. | Analgetic dosage continuously administered during the measurement interval. [µg/kg/h] | From 90 minutes before to 10 minutes after encephalographic measurement |