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Completed

NCT Number: NCT04815109

Prospective Electroencephalography Evaluation of Sedation in COVID-19

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

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Key information

Conditions

Conscious Sedation Acute Respiratory Distress Syndrome Corona Virus Infection Coronaviridae Infections Coronavirus Infections Electroencephalogram Infections Lung Diseases Nidovirales Infections Pathologic Processes Pathological Conditions, Signs and Symptoms RNA Virus Infections Respiration Disorders Respiratory Distress Syndrome Respiratory Tract Diseases Virus Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Frankfurt

Frankfurt am Main, Hesse, 60590, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Encephalography measurement

Other

Encephalography measurement and partially aggravated sedation.

Primary outcomes

  1. Raw data encephalography measurement

    Time frame: 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.

  2. Processed encephalography measurement

    Time frame: 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 outcomes

  1. Dosage of continuously administered centrally acting alpha2 agonists.

    Time frame: From 90 minutes before to 10 minutes after encephalographic measurement

    Sedative dosage continuously administered during the measurement interval. [µg/kg/h]

  2. Dosage of continuously delivered central GABA receptor active substances.

    Time frame: From 90 minutes before to 10 minutes after encephalographic measurement

    Sedative dosage continuously administered during the measurement interval. [mg/kg/h]

  3. Dosage of continuously delivered central NMDA receptor active substances.

    Time frame: From 90 minutes before to 10 minutes after encephalographic measurement

    Sedative dosage continuously administered during the measurement interval. [mg/kg/h]

  4. Dosage of continuously delivered opioid based analgesia.

    Time frame: From 90 minutes before to 10 minutes after encephalographic measurement

    Analgetic dosage continuously administered during the measurement interval. [µg/kg/h]

Sponsors and collaborators

Lead sponsor

Goethe University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Mar 24, 2021
Registry last updated
Aug 5, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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