Evaluation of Circadian Variation of EEG Using BIS Monito... | NCT02833181

Studies
Evaluation of Circadian Variation of EEG Using BIS Monitor in ICU Patients

NCT02833181

Sponsor

Centro Hospitalar do Tâmega e Sousa

Status

Completed

Last Update Posted

May 23, 2017Actual

Enrollment

30Actual

Phase

Not provided

Conditions

EEG Circadian Variation of ICU Patients

Interventions

BIS monitor

Countries

Portugal

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2016

Primary Completion Date

Apr 2017Actual

Completion Date

May 2017Actual

First Submitted Date

Jul 12, 2016

First Submission Date that Met QC Criteria

Jul 13, 2016

First Posted Date

Jul 14, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 21, 2017

Last Update Posted Date

May 23, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Mariana Marques da Cunha, MD, Centro Hospitalar do Tâmega e SousaPrincipal Investigator

Lead Sponsor

Centro Hospitalar do Tâmega e SousaOTHER

Collaborators

Not provided

Description Module

Brief Summary

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Arms/Interventions Module

Arm Groups

Label	Description	Intervention Names
Awake patients	Awake patients	Device: BIS monitor
Sedated patients		Device: BIS monitor
Sedated and curarized patients		Device: BIS monitor

Interventions

Name	Type	Description	Arm Group Labels	Other Names
BIS monitor	Device	Monitoring circadian variation of EEG	Awake patients Sedated and curarized patients Sedated patients

Measure	Description	Time Frame
Circadian EEG variation		24 hours

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Admitted in the ICU
Over 18 years old

Exclusion Criteria:

Acute neurological disease

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

100 Years

Standard Ages

AdultOlder Adult

Study Population

ICU patients

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Centro Hospitalar Tâmega e Sousa		Penafiel		4564-007	Portugal