Bilateral Bispectral Index (BIS)-Monitoring in Cardiac Surgery Patients

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Martin Soehle, University Hospital, Bonn

ClinicalTrials.gov Identifier:

NCT01048775

First received: January 13, 2010

Last updated: April 15, 2012

Last verified: April 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

January 13, 2010

Last Updated Date

April 15, 2012

Start Date ^ICMJE

February 2010

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

BIS side difference [ Time Frame: intra- and postoperative (day 1) ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT01048775 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

ADL = Activity of Daily Living [ Time Frame: 6 month after surgery ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Bilateral Bispectral Index (BIS)-Monitoring in Cardiac Surgery Patients

Official Title ^ICMJE

Investigation on the Diagnostic and Predictive Value of Bilateral Bispectral Index (BIS)-Monitoring in Cardiac Surgery

Brief Summary

The bispectral index (BIS) is derived from a single-channel electroencephalogram (EEG) and provides information on the anaesthetic depth. Recently, a bilateral two-channel EEG-sensor has been introduced to monitor the BIS on both cerebral hemispheres. In some patients significant left-right differences may occur, whereas no relevant side differences are expected in the majority of patients.

The aim of this study is to

investigate the incidence, duration and degree of left-right BIS differences
examine the relation between BIS differences and occurrence of cognitive deficits

Detailed Description

Not Provided

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Cohort
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Probability Sample

Study Population

patients treated at a University Hospital

Condition ^ICMJE

Cardiac Surgery Patients

Intervention ^ICMJE

Not Provided

Study Group/Cohort (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

Not Provided

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

Inclusion Criteria:

patients scheduled for cardiac surgery

Exclusion Criteria:

pregnancy

Gender

Both

Ages

60 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Germany

Administrative Information

NCT Number ^ICMJE

NCT01048775

Other Study ID Numbers ^ICMJE

BLB-09, Projekt-Nr UKB: N-017.0160

Has Data Monitoring Committee

Responsible Party

Martin Soehle, University Hospital, Bonn

Study Sponsor ^ICMJE

University Hospital, Bonn

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Martin Soehle, M.D., D.E.S.A., D. habil.

Dept. of Anaesthesiology and Intensive Care Medicine

Information Provided By

University Hospital, Bonn

Verification Date

April 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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