Prospective Electroencephalography Evaluation of Sedation in COVID-19

Completed

• Conditions: Conscious Sedation; Pathologic Processes; Electroencephalogram; Corona Virus Infection; Acute Respiratory Distress Syndrome
• Interventions: Other: Encephalography measurement

• Registration Number: NCT04815109
• Lead Sponsor: Goethe University

Brief Summary

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

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 Timeline

• Study First Submitted: 2021-03-23
• Study First Submitted QC: 2021-03-23
• Study First Posted: 2021-03-24
• Study Start: 2021-04-01
• Primary Completion: 2022-02-28
• Study Completion: 2022-06-30
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-04
• Last Update Posted: 2022-08-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
critical ill COVID-19	Encephalography measurement	Critically ill COVID-19 patients with need for ventilation and appropriate sedation

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University Hospital Frankfurt; 🇩🇪 Frankfurt, Hessen, Germany