Continuous Quantified EEG 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.

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Key information

Conditions

Coma Brain Diseases Brain Injuries Brain Injuries, Traumatic Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Consciousness Disorders Craniocerebral Trauma Hemorrhage Intracranial Hemorrhages Ischemic Stroke Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms Stroke Subarachnoid Hemorrhage Trauma, Nervous System Traumatic Brain Injury Unconsciousness Vascular Diseases Wounds and Injuries

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Azienda Ospedaliera Papa Giovanni Xxiii, Bergamo, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Time frame: 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

Sponsors and collaborators

Lead sponsor

Azienda Ospedaliera San Gerardo di Monza

Other

Collaborators

Papa Giovanni XXIII Hospital

Registry information

Official study title

Utility of Continuous Electroencephalogram and Derived Variables in NeuroIntensive Care

Acronym: CrazyEEG

Important dates

Study start: 2016
Primary completion: 2017
Study completion: 2017
First posted: Sep 15, 2016
Registry last updated: Mar 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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