Conscious SedationNCT04815109
Prospective Electroencephalography Evaluation of Sedation in COVID-19
An observational study of Conscious Sedation and Pathologic Processes, run by Goethe University at 1 site in Germany.
Trial summary
Sedation of severe COVID-19 disease are often complicated. We try to find a correlate for this observation by encephalographic studies. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Conscious Sedation, Pathologic Processes, Electroencephalogram
- What is being tested?
- Encephalography measurement
- How many people
- 50 participants
- Where
- 1 siteGermany
- Study dates
- 1 Apr 2021to 30 Jun 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Intubated ventilated patients with SARS-CoV-2 associated acute respiratory distress syndrome and sedation difficulty.
Who cannot join
- Pre-existing severe cerebral brain damage and dysfunction. For example: previous medial infarction, cerebral hemorrhage, structural epilepsy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Evaluation of Aggravated Sedation in COVID-19 ARDS Patients Using Electroencephalography
Sedation of severe COVID-19 disease are often complicated. We try to find a correlate for this observation by encephalographic studies.
Read the 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.
- Conditions
- Conscious Sedation, Pathologic Processes, Electroencephalogram, Acute Respiratory Distress Syndrome, Corona Virus Infection
- Being tested
- Encephalography measurement
- Medical subject headings
- Pathologic Processes, Respiratory Distress Syndrome, Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Encephalography measurementOther
Encephalography measurement and partially aggravated sedation.
| Study group | Role | What they receive |
|---|---|---|
| critical ill COVID-19 | Critically ill COVID-19 patients with need for ventilation and appropriate sedation Receives: Other: Encephalography measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Raw data encephalography measurement
Measurement of the brain activity detectable for the examination procedure in the surface encephalogram.
Measured: From the beginning of the measurement until the end of the examination (10 to 20 minutes).
Processed encephalography measurement
Measurement of detectable algorithm based patient sedation score based on brain activity in the surface encephalogram.
Measured: From the beginning of the measurement until the end of the examination (10 to 20 minutes).
Secondary outcomes (4)
Dosage of continuously administered centrally acting alpha2 agonists.
Sedative dosage continuously administered during the measurement interval. [µg/kg/h]
Measured: From 90 minutes before to 10 minutes after encephalographic measurement
Dosage of continuously delivered central GABA receptor active substances.
Sedative dosage continuously administered during the measurement interval. [mg/kg/h]
Measured: From 90 minutes before to 10 minutes after encephalographic measurement
Dosage of continuously delivered central NMDA receptor active substances.
Sedative dosage continuously administered during the measurement interval. [mg/kg/h]
Measured: From 90 minutes before to 10 minutes after encephalographic measurement
Dosage of continuously delivered opioid based analgesia.
Analgetic dosage continuously administered during the measurement interval. [µg/kg/h]
Measured: From 90 minutes before to 10 minutes after encephalographic measurement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2021
- Study start1 Apr 2021
- Primary completion28 Feb 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Conscious SedationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Goethe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Armin N. Flinspach, Goethe University
- Investigators
- Armin N Flinspach, M.D., Principal investigator, Goethe-University Frankfurt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04815109
- Sponsor's protocol ID
- EEG in COVID-19
- Status last verified
- Aug 2022
- First submitted
- 23 Mar 2021
- Last updated
- 5 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The datasets generated and/or analyzed during the current study are not publicly available due to national data protection laws. Upon justified request, the data will be accessible at the primary investigator.
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of Aggravated Sedation in COVID-19 ARDS Patients Using Electroencephalography
- ClinicalTrials.gov ID
- NCT04815109
- Acronym / sponsor ID
- EEG in COVID-19
- Conditions
- Conscious Sedation, Pathologic Processes, Electroencephalogram, Acute Respiratory Distress Syndrome, Corona Virus Infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Goethe UniversityUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 28 Feb 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 24 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| critical ill COVID-19 | – | Other: Encephalography measurementCritically ill COVID-19 patients with need for ventilation and appropriate sedation |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Intubated ventilated patients with SARS-CoV-2 associated acute respiratory distress syndrome and sedation difficulty.
Key exclusion criteria (1 listed)
- Pre-existing severe cerebral brain damage and dysfunction. For example: previous medial infarction, cerebral hemorrhage, structural epilepsy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Encephalography measurementEncephalography measurement and partially aggravated sedation. | Other | critical ill COVID-19 |
Primary outcome
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.
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.
4 secondary outcomes
Dosage of continuously administered centrally acting alpha2 agonists.
Time frame: From 90 minutes before to 10 minutes after encephalographic measurement
Dosage of continuously delivered central GABA receptor active substances.
Time frame: From 90 minutes before to 10 minutes after encephalographic measurement
Dosage of continuously delivered central NMDA receptor active substances.
Time frame: From 90 minutes before to 10 minutes after encephalographic measurement
Dosage of continuously delivered opioid based analgesia.
Time frame: From 90 minutes before to 10 minutes after encephalographic measurement
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2022.
- Individual participant dataSharing planned: No. The datasets generated and/or analyzed during the current study are not publicly available due to national data protection laws. Upon justified request, the data will be accessible at the primary investigator.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Armin N Flinspach, M.D. principal investigator
Goethe-University Frankfurt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Conscious Sedation and Pathologic Processes, run by Goethe University at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Raw data encephalography measurement (time frame: From the beginning of the measurement until the end of the examination (10 to 20 minutes).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2022.