Bilateral Bispectral Index (BIS)-Monitoring in Cardiac Su... | NCT01048775

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

NCT01048775

Sponsor

University Hospital, Bonn

Status

Completed

Last Update Posted

Apr 17, 2012Estimated

Enrollment

87Actual

Phase

Not provided

Conditions

Cardiac Surgery Patients

Interventions

Not provided

Countries

Germany

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

ID	Type	Description	Link
Projekt-Nr UKB: N-017.0160

Status Module

Record Verification Date

Apr 2012

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

Feb 2010

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Jan 13, 2010

First Submission Date that Met QC Criteria

Jan 13, 2010

First Posted Date

Jan 14, 2010Estimated

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

Apr 15, 2012

Last Update Posted Date

Apr 17, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

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

87Actual

Measure	Description	Time Frame
BIS side difference		intra- and postoperative (day 1)

Measure	Description	Time Frame
ADL = Activity of Daily Living		6 month after surgery

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients scheduled for cardiac surgery

Exclusion Criteria:

pregnancy

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

60 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

patients treated at a University Hospital

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Martin Soehle, M.D., D.E.S.A., D. habil.	Dept of Anaesthesiology and Intensive Care Medicine	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Dept. of Anaesthesiology and Intensive Care Medicine, University of Bonn		Bonn		53105	Germany

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
25928189	Derived	Soehle M, Dittmann A, Ellerkmann RK, Baumgarten G, Putensen C, Guenther U. Intraoperative burst suppression is associated with postoperative delirium following cardiac surgery: a prospective, observational study. BMC Anesthesiol. 2015 Apr 28;15:61. doi: 10.1186/s12871-015-0051-7.