Continuous Quantified EEG in NeuroIntensive Care

Traumatic Brain Injury Clinical Trial

— CrazyEEG  

Official title:

Utility of Continuous Electroencephalogram and Derived Variables in NeuroIntensive Care

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02901262
• Other study ID #: EEG2016
• Status: Completed
• Start date: January 2016
• Est. completion date: January 2017

Study information

• Verified date: September 2023
• Source: Azienda Ospedaliera San Gerardo di Monza
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: January 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Coma
• Hemorrhage
• Ischemic Stroke
• Subarachnoid Hemorrhage
• Traumatic Brain Injury

Locations

Country	Name	City	State
Italy	Azienda Ospedaliera Papa Giovanni Xxiii	Bergamo
Italy	Azienda Ospedaliera San Gerardo	Monza

Sponsors (2)

Lead Sponsor	Collaborator
Azienda Ospedaliera San Gerardo di Monza	Papa Giovanni XXIII Hospital

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	2 months
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	12 months