Continuous Quantified EEG in NeuroIntensive Care

Completed

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

• Registration Number: NCT02901262
• Lead Sponsor: Azienda Ospedaliera San Gerardo di Monza

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.

Study Timeline

• Study Start: 2016-01
• Study First Submitted: 2016-08-19
• Study First Submitted QC: 2016-09-09
• Study First Posted: 2016-09-15
• Primary Completion: 2017-01
• Study Completion: 2017-01
• Results First Submitted: 2018-04-13
• Status Verified: 2023-09
• Results First Submitted QC: 2023-09-21
• Last Update Submitted: 2023-09-21
• Results First Posted: 2024-03-22
• Last Update Posted: 2024-03-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of Correct qEEG Evaluations	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 Outcome Measures

Name	Time	Method
Kappa Coefficient of Agreement Between Intensivists and Neurophysiologists After Training	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

Trial Locations

Locations (2)

Azienda Ospedaliera Papa Giovanni Xxiii; 🇮🇹 Bergamo, Italy

Azienda Ospedaliera San Gerardo; 🇮🇹 Monza, Italy