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Continuous Quantified EEG in NeuroIntensive Care (CrazyEEG)

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ClinicalTrials.gov Identifier: NCT02901262
Recruitment Status : Completed
First Posted : September 15, 2016
Last Update Posted : March 3, 2017
Sponsor:
Collaborator:
Papa Giovanni XXIII Hospital
Information provided by (Responsible Party):
Prof. Giuseppe Citerio, Azienda Ospedaliera San Gerardo di Monza

Brief Summary:
To evaluate the ability of NICU staff to interpret, before and after a training period, symmetry, sedation level, seizures activities and artefact on continuous cEEG/qEEG tracings.

Condition or disease
Coma Traumatic Brain Injury Subarachnoid Hemorrhage Ischemic Stroke

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:

  • symmetry,
  • 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.

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Study Type : Observational [Patient Registry]
Actual Enrollment : 15 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 10 Days
Official Title: Utility of Continuous Electroencephalogram and Derived Variables in NeuroIntensive Care
Study Start Date : January 2016
Actual Primary Completion Date : January 2017
Actual Study Completion Date : January 2017

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



Primary Outcome Measures :
  1. Evaluate the intensivist's performance in reading qEEG [ Time Frame: 2 months ]

    % of the correct evaluation of qEEG tracings by intensivists vs. neurophysiologist analyzing these domains:

    • symmetry,
    • sedation level,
    • seizures activities and
    • artefact on continuous cEEG/qEEG tracings. The result will be expressed as % of correct answer for each evaluated domain.


Secondary Outcome Measures :
  1. Improvement after the training [ Time Frame: 12 months ]

    Comparison of the correct answers of the intensivist before and after a period of training.

    The domains evaluated on qEEG are:

    • symmetry,
    • sedation level,
    • seizures activities and
    • artefact on continuous cEEG/qEEG tracings. The result will be expressed as difference in % before and after the training



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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02901262


Locations
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Italy
Azienda Ospedaliera Papa Giovanni Xxiii
Bergamo, Italy, 24100
Azienda Ospedaliera San Gerardo
Monza, Italy, 20052
Sponsors and Collaborators
Azienda Ospedaliera San Gerardo di Monza
Papa Giovanni XXIII Hospital
Investigators
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Principal Investigator: Giuseppe Citerio, MD Università Milano Bicocca

Additional Information:

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Responsible Party: Prof. Giuseppe Citerio, NeuroIntensive Care Director, Azienda Ospedaliera San Gerardo di Monza
ClinicalTrials.gov Identifier: NCT02901262     History of Changes
Other Study ID Numbers: EEG2016
First Posted: September 15, 2016    Key Record Dates
Last Update Posted: March 3, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Prof. Giuseppe Citerio, Azienda Ospedaliera San Gerardo di Monza:
continuous EEG
Additional relevant MeSH terms:
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Brain Injuries
Brain Injuries, Traumatic
Subarachnoid Hemorrhage
Hemorrhage
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Pathologic Processes
Intracranial Hemorrhages
Cerebrovascular Disorders
Vascular Diseases
Cardiovascular Diseases