Continuous Quantified EEG in NeuroIntensive Care

NCT02901262 | Completed Results

• 1 other identifier: EEG2016
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 2

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.

Conditions

Coma; Traumatic Brain Injury; Subarachnoid Hemorrhage; Ischemic Stroke

Keywords

continuous EEG

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Kappa Coefficient of Agreement Between Intensivists and Neurophysiologists After Training

  12 months

Study Arms (1)

qEEG patients

All the patients with continuous EEG (\>24 hours) in the two study units

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• No EEG recording \> 24 hours

Sponsors & Collaborators

• Azienda Ospedaliera San Gerardo di Monza: lead
• Papa Giovanni XXIII Hospital: collaborator

Study Sites (2)

Azienda Ospedaliera Papa Giovanni Xxiii

Bergamo, 24100, Italy

Location

Azienda Ospedaliera San Gerardo

Monza, 20052, Italy

Location

MeSH Terms

Conditions

Coma; Brain Injuries, Traumatic; Subarachnoid Hemorrhage; Ischemic Stroke

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Prof. Giuseppe Citerio
• Organization: UNIMIB, ASST-MONZA San Gerardo Hospital

giuseppe.citerio@unimib.it

0039 039 233 4316

Study Officials

• Giuseppe Citerio, MD

  Università Milano Bicocca

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: NeuroIntensive Care Director

Study Record Dates

• First Submitted: August 19, 2016
• First Posted: September 15, 2016
• Study Start: January 1, 2016
• Primary Completion: January 1, 2017
• Study Completion: January 1, 2017
• Last Updated: March 22, 2024
• Results First Posted: March 22, 2024

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

IT (2)