MedDataX Logo

Comparability of Bispectral Index and NeuroSENSE in Aged Patients

NCT ID: NCT02015741

Last Updated: 2016-10-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2013-11-30

Study Completion Date

2015-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Sleep

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Aged patients

EEG monitoring with Bispectral Index and NeuroSENSE

EEG monitoring with Bispectral Index and NeuroSENSE

Intervention Type DEVICE

Clinical observation

Intervention Type BEHAVIORAL

Patients will be observed during awake periods and during natural sleep.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

EEG monitoring with Bispectral Index and NeuroSENSE

Intervention Type DEVICE

Clinical observation

Patients will be observed during awake periods and during natural sleep.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* patients older than 74 years

Exclusion Criteria

* pace-maker
Minimum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Hopital Foch

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Julie Bresson, MD

Role: PRINCIPAL_INVESTIGATOR

Hopital Foch

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Hopital Stell

Rueil, Hauts de Seine, France

Site Status

Hopital Foch

Suresnes, Hauts de Seine, France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2012-A01192-41

Identifier Type: OTHER

Identifier Source: secondary_id

2012/36

Identifier Type: -

Identifier Source: org_study_id