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| Name | Class |
|---|---|
| Papa Giovanni XXIII Hospital | OTHER |
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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.
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:
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| qEEG patients | All the patients with continuous EEG (>24 hours) in the two study units |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 2 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Intensivists wil evaluate daily qEEG recordings of:
Exclusion Criteria:
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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
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| Name | Affiliation | Role |
|---|---|---|
| Giuseppe Citerio, MD | Università Milano Bicocca | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Azienda Ospedaliera Papa Giovanni Xxiii | Bergamo | 24100 | Italy | |||
| Azienda Ospedaliera San Gerardo |
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After the evaluation of qEEG (quantitative electroencephalography) from 30 patients, other intensivists and neurophysiologists were engaged to use the customized web-based online application that was downloaded on computers and cell phones to evaluate qEEG.
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| ID | Title | Description |
|---|---|---|
| FG000 | Study Cohort | From February to August 2016 periods of >12 h of cEEG (continuous electroencephalography) were independently evaluated by intensivists and by neurophysiologists using a customized web-based online application that was downloaded on computers and cell phones. A total of 86 paired evaluations were performed in 30 patients, and 1740 h of qEEG (quantitative electroencephalography) was subsequently evaluated. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | qEEG Patients | All the patients with continuous EEG (>24 hours) in the two study units |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Neuro-intensivists, after the in-house training | Posted | Number | percentage of correct evaluation | 2 months | qEEG evaluations | qEEG evaluations |
|
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All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | qEEG Patients | All the patients with continuous EEG (>24 hours) in teh two study units |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prof. Giuseppe Citerio | UNIMIB, ASST-MONZA San Gerardo Hospital | 0039 039 233 4316 | giuseppe.citerio@unimib.it |
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| ID | Term |
|---|---|
| D003128 | Coma |
| D000070642 | Brain Injuries, Traumatic |
| D013345 | Subarachnoid Hemorrhage |
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D014474 | Unconsciousness |
| D003244 | Consciousness Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
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| 12 months |
| Monza |
| 20052 |
| Italy |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|
| Participants |
|
| qEEG evaluations |
|
|
| Secondary | 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 | Agreement between neurophysiologists and intensivists in interpretation of the tracings after training | Posted | Mean | 95% Confidence Interval | Kappa Coefficient | 12 months | qEEG evaluations | qEEG evaluations |
|
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|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
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| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
| D020300 | Intracranial Hemorrhages |
| D002561 | Cerebrovascular Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D020521 | Stroke |
| Title | Measurements |
|---|---|
|
| Sedation |
|