Comparison of Two Electroencephalogram (EEG)-Derived Indi... | NCT01077674

Studies
Comparison of Two Electroencephalogram (EEG)-Derived Indices With Electroencephalogram Signals

NCT01077674

Sponsor

Arvi Yli-Hankala

Status

Completed

Last Update Posted

Oct 9, 2013Estimated

Enrollment

65Actual

Phase

Not provided

Conditions

Anaesthesia
Surgery

Interventions

Not provided

Countries

Finland

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

Oct 2013

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

Dec 2009

Primary Completion Date

Mar 2011Actual

Completion Date

Mar 2011Actual

First Submitted Date

Feb 26, 2010

First Submission Date that Met QC Criteria

Feb 26, 2010

First Posted Date

Mar 1, 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

Oct 8, 2013

Last Update Posted Date

Oct 9, 2013Estimated

Name	Class
Tampere University Hospital	OTHER

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

Bispectral Index (BIS) and Entropy indices will be compared with each other, and to raw EEG signals in patients receiving sevoflurane anaesthesia. BIS and Entropy numbers often differ significantly from each other during surgery, and the reason for this has not been studied in detail, therefore remaining only poorly understood. BIS and Entropy, together with multi-channel EEG, will be collected and analyzed later on. Course of anaesthesia and surgery will be annotated. All relevant information from anaesthesia monitor will be collected on computer.

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

65Actual

Label	Type	Description	Intervention Names
Entropy - BIS		Patients undergoing surgery in sevoflurane anaesthesia.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Morphology of electroencephalogram during discrepancy between Entropy and BIS index values		15 minutes

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Planned surgery necessitating general anaesthesia
Expected duration of anaesthesia 30 min or more
Need of endotracheal intubation
ASA status 1, 2 or 3

Exclusion Criteria:

Significant disorders of the autonomic or central nervous system
Family history of malignant hyperthermia
Clinical history of anaphylactic reaction against inhaled anaesthetics
Disability to communicate with Finnish language

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Middle aged and elderly surgical patients

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Arvi Yli-Hankala, MD	Tampere University Hospital	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Tampere University Hospital		Tampere		33521	Finland

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
26137969	Derived	Aho AJ, Kamata K, Jantti V, Kulkas A, Hagihira S, Huhtala H, Yli-Hankala A. Comparison of Bispectral Index and Entropy values with electroencephalogram during surgical anaesthesia with sevoflurane. Br J Anaesth. 2015 Aug;115(2):258-66. doi: 10.1093/bja/aev206. Epub 2015 Jul 1.