Comparability of Bispectral Index and NeuroSENSE in Aged Patients

Withdrawn

• Conditions: Sleep

• 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• Status: WITHDRAWN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

Exclusion Criteria

• pace-maker

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

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 Stell; 🇫🇷 Rueil, Hauts de Seine, France

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