Prospective Electroencephalography Evaluation of Sedation in COVID-19

Acute Respiratory Distress Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04815109
• Other study ID #: EEG in COVID-19
• Status: Completed
• Start date: April 1, 2021
• Est. completion date: June 30, 2022

Study information

• Verified date: August 2022
• Source: Goethe University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: June 30, 2022
• Est. primary completion date: February 28, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute Lung Injury
• Acute Respiratory Distress Syndrome
• Conscious Sedation
• Corona Virus Infection
• Coronavirus Infections
• Electroencephalogram
• Pathologic Processes
• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Newborn

Intervention

Other:
• Encephalography measurement
Encephalography measurement and partially aggravated sedation.

Locations

Country	Name	City	State
Germany	University Hospital Frankfurt	Frankfurt	Hessen

Sponsors (1)

Lead Sponsor	Collaborator
Goethe University

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).
Primary	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	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
Secondary	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
Secondary	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
Secondary	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