Continuous Quantified EEG in NeuroIntensive Care (CrazyEEG)

Utility of Continuous Electroencephalogram and Derived Variables 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.

Study Overview

• Status: Completed
• Conditions: Ischemic Stroke; Traumatic Brain Injury; Subarachnoid Hemorrhage; Coma

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.

• Study Type: Observational
• Enrollment (Actual): 30

Contacts and Locations

Study Locations

• Italy
  • Bergamo, Italy, 24100
    • Azienda Ospedaliera Papa Giovanni XXIII
  • Monza, Italy, 20052
    • Azienda Ospedaliera San Gerardo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
qEEG patients; All the patients with continuous EEG (>24 hours) in the two study units

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	12 months

Collaborators and Investigators

• Sponsor: Azienda Ospedaliera San Gerardo di Monza
• Collaborators: Papa Giovanni XXIII Hospital
• Investigators: Principal Investigator: Giuseppe Citerio, MD, Università Milano Bicocca

Study record dates

Study Major Dates

• Study Start: January 1, 2016
• Primary Completion (Actual): January 1, 2017
• Study Completion (Actual): January 1, 2017

Study Registration Dates

• First Submitted: August 19, 2016
• First Submitted That Met QC Criteria: September 9, 2016
• First Posted (Estimated): September 15, 2016

Study Record Updates

• Last Update Posted (Actual): March 22, 2024
• Last Update Submitted That Met QC Criteria: September 21, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: continuous EEG
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Stroke; Intracranial Hemorrhages; Ischemic Stroke; Brain Injuries; Hemorrhage; Brain Injuries, Traumatic; Subarachnoid Hemorrhage
• Other Study ID Numbers: EEG2016

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO