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Clinical Trials/NCT02901262
NCT02901262
Completed
Not Applicable

Utility of Continuous Electroencephalogram and Derived Variables in NeuroIntensive Care

Azienda Ospedaliera San Gerardo di Monza2 sites in 1 country30 target enrollmentJanuary 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Coma
Sponsor
Azienda Ospedaliera San Gerardo di Monza
Enrollment
30
Locations
2
Primary Endpoint
Number of Correct qEEG Evaluations
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 2016
End Date
January 2017
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Azienda Ospedaliera San Gerardo di Monza
Responsible Party
Principal Investigator
Principal Investigator

Prof. Giuseppe Citerio

NeuroIntensive Care Director

Azienda Ospedaliera San Gerardo di Monza

Eligibility Criteria

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

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Kappa Coefficient of Agreement Between Intensivists and Neurophysiologists After Training(12 months)

Study Sites (2)

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