Coma, Ischemic Stroke, Subarachnoid Hemorrhage, Traumatic Brain Injury
Conditions
Keywords
continuous EEG
Brief 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.
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.
Interventions
None listed
Sponsors
Papa Giovanni XXIII Hospital
Azienda Ospedaliera San Gerardo di Monza
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
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
Exclusion criteria
* No EEG recording \> 24 hours
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Correct qEEG Evaluations | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Kappa Coefficient of Agreement Between Intensivists and Neurophysiologists After Training | 12 months | 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 |
Countries
Italy
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| qEEG Patients All the patients with continuous EEG (\>24 hours) in the two study units | 30 |
| Total | 30 |
Baseline characteristics
| Characteristic | qEEG Patients | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 0 Participants | — |
| Age, Categorical Between 18 and 65 years | 30 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Italy | 30 participants | — |
| Sex: Female, Male Female | 18 Participants | — |
| Sex: Female, Male Male | 12 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 0 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
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.
Time frame: 2 months
Population: Neuro-intensivists, after the in-house training
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Study Cohort | Number of Correct qEEG Evaluations | Simmetry | 70 percentage of correct evaluation |
| Study Cohort | Number of Correct qEEG Evaluations | Sedation level | 78 percentage of correct evaluation |
| Study Cohort | Number of Correct qEEG Evaluations | Seizures activities | 69 percentage of correct evaluation |
| Study Cohort | Number of Correct qEEG Evaluations | artefact on continuous cEEG/qEEG tracings | 82 percentage of correct evaluation |
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
Time frame: 12 months
Population: Agreement between neurophysiologists and intensivists in interpretation of the tracings after training
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Study Cohort | Kappa Coefficient of Agreement Between Intensivists and Neurophysiologists After Training | Seizures | 0.5 Kappa Coefficient |
| Study Cohort | Kappa Coefficient of Agreement Between Intensivists and Neurophysiologists After Training | Simmetry | 0.65 Kappa Coefficient |
| Study Cohort | Kappa Coefficient of Agreement Between Intensivists and Neurophysiologists After Training | Artefacts | 0.6 Kappa Coefficient |
| Study Cohort | Kappa Coefficient of Agreement Between Intensivists and Neurophysiologists After Training | Sedation | 0.75 Kappa Coefficient |