Prospective Electroencephalography Evaluation of Sedation in COVID-19

Sponsor
Goethe University (Other)
Overall Status
Completed
CT.gov ID
NCT04815109
Collaborator
(none)
50
1
14.9
3.3

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Other: Encephalography measurement

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 Design

Study Type:
Observational
Actual Enrollment :
50 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Prospective Evaluation of Aggravated Sedation in COVID-19 ARDS Patients Using Electroencephalography
Actual Study Start Date :
Apr 1, 2021
Actual Primary Completion Date :
Feb 28, 2022
Actual Study Completion Date :
Jun 30, 2022

Arms and Interventions

Arm Intervention/Treatment
critical ill COVID-19

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

Other: Encephalography measurement
Encephalography measurement and partially aggravated sedation.

Outcome Measures

Primary Outcome Measures

  1. 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.

  2. 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

  1. 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]

  2. 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]

  3. 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]

  4. 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]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 University Hospital Frankfurt Frankfurt Hessen Germany 60590

Sponsors and Collaborators

  • Goethe University

Investigators

  • Principal Investigator: Armin N Flinspach, M.D., Goethe-University Frankfurt

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Armin N. Flinspach, Principal Investigator, Goethe University
ClinicalTrials.gov Identifier:
NCT04815109
Other Study ID Numbers:
  • EEG in COVID-19
First Posted:
Mar 24, 2021
Last Update Posted:
Aug 5, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 5, 2022