Clinical trial NCT04815109: Prospective Electroencephalography Evaluation of Sedation in COVID-19
Official title: Prospective Evaluation of Aggravated Sedation in COVID-19 ARDS Patients Using Electroencephalography
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Conscious Sedation
Pathologic Processes
Electroencephalogram
Acute Respiratory Distress Syndrome
Corona Virus Infection
Lead sponsor: Goethe University
Sponsor class: OTHER
First posted: 2021-03-24
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Raw data encephalography measurement
timeFrame: From the beginning of the measurement until the end of the examination (10 to 20 minutes).
measure: Processed encephalography measurement
timeFrame: From the beginning of the measurement until the end of the examination (10 to 20 minutes).
Secondary outcomes:
measure: Dosage of continuously administered centrally acting alpha2 agonists.
timeFrame: From 90 minutes before to 10 minutes after encephalographic measurement
measure: Dosage of continuously delivered central GABA receptor active substances.
timeFrame: From 90 minutes before to 10 minutes after encephalographic measurement
measure: Dosage of continuously delivered central NMDA receptor active substances.
timeFrame: From 90 minutes before to 10 minutes after encephalographic measurement
measure: Dosage of continuously delivered opioid based analgesia.
timeFrame: From 90 minutes before to 10 minutes after encephalographic measurement
Other outcomes:
Locations:
city: Frankfurt
country: Germany
facility: University Hospital Frankfurt
state: Hessen
Study officials:
affiliation: Goethe-University Frankfurt
name: Armin N Flinspach, M.D.
role: PRINCIPAL_INVESTIGATOR
References: