NCT02833181

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2016

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2016

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

July 12, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 14, 2016

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
Last Updated

May 23, 2017

Status Verified

May 1, 2017

Enrollment Period

9 months

First QC Date

July 12, 2016

Last Update Submit

May 21, 2017

Conditions

EEG Circadian Variation of ICU Patients

Outcome Measures

Primary Outcomes (1)

  • Circadian EEG variation

    24 hours

Study Arms (3)

Awake patients

Awake patients

Device: BIS monitor

Sedated patients

Device: BIS monitor

Sedated and curarized patients

Device: BIS monitor

Interventions

BIS monitorDEVICE

Monitoring circadian variation of EEG

Awake patientsSedated and curarized patientsSedated patients

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

ICU patients

You may qualify if:

  • Admitted in the ICU
  • Over 18 years old

You may not qualify if:

  • Acute neurological disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centro Hospitalar Tâmega e Sousa

Penafiel, 4564-007, Portugal

Location

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

July 12, 2016

First Posted

July 14, 2016

Study Start

July 1, 2016

Primary Completion

April 1, 2017

Study Completion

May 1, 2017

Last Updated

May 23, 2017

Record last verified: 2017-05

Locations

PT(1)