Prospective Electroencephalography Evaluation of Sedation in COVID-19

NCT04815109 | Completed

• 1 other identifier: EEG in COVID-19
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Dosage of continuously administered centrally acting alpha2 agonists.

  From 90 minutes before to 10 minutes after encephalographic measurement

• Dosage of continuously delivered central GABA receptor active substances.

  From 90 minutes before to 10 minutes after encephalographic measurement

• Dosage of continuously delivered central NMDA receptor active substances.

  From 90 minutes before to 10 minutes after encephalographic measurement

• Dosage of continuously delivered opioid based analgesia.

  From 90 minutes before to 10 minutes after encephalographic measurement

Study Arms (1)

critical ill COVID-19

Critically ill COVID-19 patients with need for ventilation and appropriate sedation

Other: Encephalography measurement

Interventions

Encephalography measurement OTHER

Encephalography measurement and partially aggravated sedation.

critical ill COVID-19

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Intubated ventilated patients with SARS-CoV-2 associated acute respiratory distress syndrome and sedation difficulty.

You may not qualify if:

• Pre-existing severe cerebral brain damage and dysfunction. For example: previous medial infarction, cerebral hemorrhage, structural epilepsy.

Sponsors & Collaborators

• Goethe University: lead

Study Sites (1)

University Hospital Frankfurt

Frankfurt am Main, Hesse, 60590, Germany

Location

MeSH Terms

Conditions

Pathologic Processes; Respiratory Distress Syndrome; Coronavirus Infections

Condition Hierarchy (Ancestors)

Pathological Conditions, Signs and Symptoms; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections

Study Officials

• Armin N Flinspach, M.D.

  Goethe-University Frankfurt

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 23, 2021
• First Posted: March 24, 2021
• Study Start: April 1, 2021
• Primary Completion: February 28, 2022
• Study Completion: June 30, 2022
• Last Updated: August 5, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)