Comparability of Bispectral Index and NeuroSENSE in Aged Patients

Withdrawn

• Conditions: Sleep
• Interventions: Device: EEG monitoring with Bispectral Index and NeuroSENSE; Behavioral: Clinical observation

• Registration Number: NCT02015741
• Lead Sponsor: Hopital Foch

Brief Summary

The assessment of anesthesia depth was based, until recently, on the evolution of hemodynamic parameters. Nowadays it can be evaluated by several monitoring methods, derived from electroencephalogram analysis, namely the Bispectral Index (Aspect Medical Systems, Newton, USA). A new modality is currently under development: the NeuroSENSE (Cleveland Medical Devices Inc., Cleveland, OH 44103, USA).

Use of such devices is discussed in aged patients. The purpose of this study is to compare Bispectral Index and NeuroSENSE during awake periods and during natural sleep.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-11
• Study First Submitted: 2013-12-05
• Study First Submitted QC: 2013-12-13
• Study First Posted: 2013-12-19
• Primary Completion: 2015-11
• Study Completion: 2015-12
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-28
• Last Update Posted: 2016-10-31

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• patients older than 74 years

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Exclusion Criteria

• pace-maker

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Aged patients	EEG monitoring with Bispectral Index and NeuroSENSE	EEG monitoring with Bispectral Index and NeuroSENSE
Aged patients	Clinical observation	EEG monitoring with Bispectral Index and NeuroSENSE

Primary Outcome Measures

Name	Time	Method
Percentage of patients with a high concordance between pairs of Bispectral Index and NeuroSENSE indices	1 year	Statistical analysis of concordance between pairs of Bispectral Index and NeuroSENSE indices (high concordance when \> 0.60%)

Secondary Outcome Measures

Name	Time	Method
Percentage of patients with a high concordance between pairs of Bispectral Index and NeuroSENSE indices during periods of natural sleep	1 year	Statistical analysis of concordance between pairs of Bispectral Index and NeuroSENSE indices measured during periods of natural sleep (high concordance when \> 0.60%)

Trial Locations

Locations (2)

Hopital Foch; 🇫🇷 Suresnes, Hauts de Seine, France

Hopital Stell; 🇫🇷 Rueil, Hauts de Seine, France