Prospective Electroencephalography Evaluation of Sedation in COVID-19

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

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

Study Overview

• Status: Completed
• Conditions: Pathologic Processes; Acute Respiratory Distress Syndrome; Corona Virus Infection; Electroencephalogram; Conscious Sedation
• Intervention / Treatment: Other: Encephalography measurement

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 50

Contacts and Locations

Study Locations

• Germany
  • Hessen
    • Frankfurt, Hessen, Germany, 60590
      • University Hospital Frankfurt

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Critically ill COVID-19 patients requiring advanced intensive care treatment with existing intubation-requiring acute respiratory distress syndrome under invasive ventilation. Adequate depth of sedation is usually required for appropriate therapy, which is frequently challenging in COVID-19 patients.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
critical ill COVID-19; Critically ill COVID-19 patients with need for ventilation and appropriate sedation	Other: Encephalography measurement; Encephalography measurement and partially aggravated sedation.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Goethe University
• Investigators: Principal Investigator: Armin N Flinspach, M.D., Goethe-University Frankfurt

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2021
• Primary Completion (Actual): February 28, 2022
• Study Completion (Actual): June 30, 2022

Study Registration Dates

• First Submitted: March 23, 2021
• First Submitted That Met QC Criteria: March 23, 2021
• First Posted (Actual): March 24, 2021

Study Record Updates

• Last Update Posted (Actual): August 5, 2022
• Last Update Submitted That Met QC Criteria: August 4, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Infant, Newborn, Diseases; Lung Injury; Infant, Premature, Diseases; Coronavirus Infections; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury; Pathologic Processes
• Other Study ID Numbers: EEG in COVID-19

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: The datasets generated and/or analyzed during the current study are not publicly available due to national data protection laws. Upon justified request, the data will be accessible at the primary investigator.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No