- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02833181
Evaluation of Circadian Variation of EEG Using BIS Monitor in ICU Patients
May 21, 2017 updated by: Mariana Marques da Cunha, Centro Hospitalar do Tâmega e Sousa
The investigators propose to evaluate circadian variation of EEG using BIS (bispectral index) monitor in ICU patients in three different groups: non-sedated, only sedated and sedated and curarized.
BIS monitor values as SR (suppression rate), SEF (Spectral edge frequency), bispectral index and EMG (electromyography) during 24 hours in admitted patients except acute neurological disease.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
30
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Penafiel, Portugal, 4564-007
- Centro Hospitalar Tâmega e Sousa
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 100 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
ICU patients
Description
Inclusion Criteria:
- Admitted in the ICU
- Over 18 years old
Exclusion Criteria:
- Acute neurological disease
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Awake patients
|
Monitoring circadian variation of EEG
|
Sedated patients
|
Monitoring circadian variation of EEG
|
Sedated and curarized patients
|
Monitoring circadian variation of EEG
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Circadian EEG variation
Time Frame: 24 hours
|
24 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2016
Primary Completion (Actual)
April 1, 2017
Study Completion (Actual)
May 1, 2017
Study Registration Dates
First Submitted
July 12, 2016
First Submitted That Met QC Criteria
July 13, 2016
First Posted (Estimate)
July 14, 2016
Study Record Updates
Last Update Posted (Actual)
May 23, 2017
Last Update Submitted That Met QC Criteria
May 21, 2017
Last Verified
May 1, 2017
More Information
Terms related to this study
Other Study ID Numbers
- BISEECS
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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