ComaCrazyEEGNCT02901262
Continuous Quantified EEG in NeuroIntensive Care
An observational study of Coma and Traumatic Brain Injury, run by Azienda Ospedaliera San Gerardo di Monza at 2 sites in Italy.
Trial summary
To evaluate the ability of NICU (NeuroIntensive Care Unit) staff to interpret, before and after a training period, symmetry, sedation level, seizures activities and artefact on continuous cEEG/qEEG (continuous electroencephalography/quantitative electroencephalography) tracings. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Coma, Traumatic Brain Injury, Subarachnoid Hemorrhage
- How many people
- 30 participants
- Where
- 2 sitesItaly
- Study dates
- Jan 2016to Jan 2017
- How long will I take part?
- 10 Days
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Intensivists will evaluate tracing from patients in coma after a traumatic/vascular event admitted to neurointensive care and recorded with continuous EEG for clinical reasons
Who may be able to join
- Intensivists wil evaluate daily qEEG recordings of:
- Patients in coma after a traumatic/vascular event
- Admitted to neurointensive care and
- Recorded with continuous EEG for clinical reasons
Who cannot join
- No EEG recording > 24 hours
Trial locations and contacts
2 sites in 1 country.
Italy2 sites
Azienda Ospedaliera Papa Giovanni Xxiii
Bergamo, 24100
Azienda Ospedaliera San Gerardo
Monza, 20052
About this study
Official title: Utility of Continuous Electroencephalogram and Derived Variables in NeuroIntensive Care
To evaluate the ability of NICU (NeuroIntensive Care Unit) staff to interpret, before and after a training period, symmetry, sedation level, seizures activities and artefact on continuous cEEG/qEEG (continuous electroencephalography/quantitative electroencephalography) tracings.
Read the detailed description
Using a web based tool, the clinicians of the two study centers will review 24 hours of recording (raw EEG data + derived qEEG variables).
The intensivists will evaluate:
- simmetry,
- sedation level,
- seizures activities and
- artefact on continuous cEEG/qEEG tracings. The same tracings will be blindly reviewed by a certified neurophysiologist (using the app). The neurophysiologist evaluation will be considered as "reference".
The results of the evaluation will be compared (intensivists vs. neurophysiologist) in order to understand if the intensivists are able to adequately identify the pathological findings.
The study period will be:
- before a formal training
- after a formal training by neurophysiologist in order to understand if the training is able to improve the intensivists performance.
- Conditions
- Coma, Traumatic Brain Injury, Subarachnoid Hemorrhage, Ischemic Stroke
- Keywords
- continuous EEG
- Medical subject headings
- Coma, Brain Injuries, Traumatic, Subarachnoid Hemorrhage, Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| qEEG patients | All the patients with continuous EEG (>24 hours) in the two study units |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Correct qEEG Evaluations
Percentage of correct evaluation of qEEG tracings by intensivists vs. neurophysiologist.
The result will be expressed as percentage of correct evaluations for each domain.
Measured: 2 months
Secondary outcomes (1)
Kappa Coefficient of Agreement Between Intensivists and Neurophysiologists After Training
Comparison of the correct answers of the intensivist before and after a period of training.
Results will be expressed as coefficient of agreement between neurophysiologists and intensivists in interpretation of the tracings of continuous electroencephalography using Cohen's kappa coefficient, after training
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2016 (estimated)
- Study startJan 2016
- Primary completionJan 2017
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for ComaStudies 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
- 30 participants (actual)
- Target duration
- 10 Days
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliera San Gerardo di Monza
- Sponsor type
- University, hospital or other
- Collaborators
- Papa Giovanni XXIII Hospital
- Responsible party
- Principal investigator, Prof. Giuseppe Citerio, Azienda Ospedaliera San Gerardo di Monza
- Investigators
- Giuseppe Citerio, MD, Principal investigator, Università Milano Bicocca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02901262
- Sponsor's protocol ID
- EEG2016
- Acronym
- CrazyEEG
- Status last verified
- Sep 2023
- First submitted
- 19 Aug 2016
- Last updated
- 22 Mar 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utility of Continuous Electroencephalogram and Derived Variables in NeuroIntensive Care
- ClinicalTrials.gov ID
- NCT02901262
- Acronym / sponsor ID
- CrazyEEG / EEG2016
- Conditions
- Coma, Traumatic Brain Injury, Subarachnoid Hemorrhage, Ischemic Stroke
- Keywords
- continuous EEG
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Azienda Ospedaliera San Gerardo di MonzaUniversity, hospital or other
- Collaborators
- Papa Giovanni XXIII Hospital
- Study start
- Jan 2016
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 15 Sep 2016 (estimated)
- Results
- Posted 22 Mar 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the ability of NICU (NeuroIntensive Care Unit) staff to interpret, before and after a training period, symmetry, sedation level, seizures activities and artefact on continuous cEEG/qEEG (continuous electroencephalography/quantitative electroencephalography) tracings.
Detailed description
Using a web based tool, the clinicians of the two study centers will review 24 hours of recording (raw EEG data + derived qEEG variables).
The intensivists will evaluate:
- simmetry,
- sedation level,
- seizures activities and
- artefact on continuous cEEG/qEEG tracings. The same tracings will be blindly reviewed by a certified neurophysiologist (using the app). The neurophysiologist evaluation will be considered as "reference".
The results of the evaluation will be compared (intensivists vs. neurophysiologist) in order to understand if the intensivists are able to adequately identify the pathological findings.
The study period will be:
- before a formal training
- after a formal training by neurophysiologist in order to understand if the training is able to improve the intensivists performance.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| qEEG patients | – | –All the patients with continuous EEG (>24 hours) in the two study units |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Intensivists will evaluate tracing from patients in coma after a traumatic/vascular event admitted to neurointensive care and recorded with continuous EEG for clinical reasons
Key inclusion criteria (4 listed)
- Patients in coma after a traumatic/vascular event
- Admitted to neurointensive care and
- Recorded with continuous EEG for clinical reasons
Key exclusion criteria (1 listed)
- No EEG recording > 24 hours
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of Correct qEEG Evaluations
Time frame: 2 months
Percentage of correct evaluation of qEEG tracings by intensivists vs. neurophysiologist. The result will be expressed as percentage of correct evaluations for each domain.
1 secondary outcome
Kappa Coefficient of Agreement Between Intensivists and Neurophysiologists After Training
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Giuseppe Citerio, MD principal investigator
Università Milano Bicocca
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coma and Traumatic Brain Injury, run by Azienda Ospedaliera San Gerardo di Monza at 2 sites in Italy.
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 4 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 22 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. 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?
Yes. Results are posted in the registry (first posted 22 Mar 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Correct qEEG Evaluations (time frame: 2 months). 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 22 Mar 2024.