Continuous Quantified EEG in NeuroIntensive Care

NCT ID: NCT02901262

Last Updated: 2024-03-22

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-01-31

Study Completion Date

2017-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Coma Traumatic Brain Injury Subarachnoid Hemorrhage Ischemic Stroke

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

qEEG patients

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

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Papa Giovanni XXIII Hospital

OTHER

Sponsor Role collaborator

Azienda Ospedaliera San Gerardo di Monza

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Prof. Giuseppe Citerio

NeuroIntensive Care Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Giuseppe Citerio, MD

Role: PRINCIPAL_INVESTIGATOR

Università Milano Bicocca

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Azienda Ospedaliera Papa Giovanni Xxiii

Bergamo, , Italy

Site Status

Azienda Ospedaliera San Gerardo

Monza, , Italy

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Italy

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

EEG2016

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

The Value of EEG in Stroke Units
NCT07190976 RECRUITING
Critical Care EEG Course
NCT03545776 COMPLETED
Pediatric EEG Monitoring
NCT04664608 COMPLETED