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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-A01192-41 | Other Identifier | ANSM |
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recruitment difficulties
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aged patients | EEG monitoring with Bispectral Index and NeuroSENSE |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EEG monitoring with Bispectral Index and NeuroSENSE | Device |
| ||
| Clinical observation |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients with a high concordance between pairs of Bispectral Index and NeuroSENSE indices | Statistical analysis of concordance between pairs of Bispectral Index and NeuroSENSE indices (high concordance when > 0.60%) | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients with a high concordance between pairs of Bispectral Index and NeuroSENSE indices during periods of natural sleep | Statistical analysis of concordance between pairs of Bispectral Index and NeuroSENSE indices measured during periods of natural sleep (high concordance when > 0.60%) | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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Aged patients
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| Name | Affiliation | Role |
|---|---|---|
| Julie Bresson, MD | Hopital Foch | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hopital Stell | Rueil | Hauts de Seine | 92500 | France | ||
| Hopital Foch |
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| ID | Term |
|---|---|
| D057832 | Watchful Waiting |
| ID | Term |
|---|---|
| D017063 | Outcome Assessment, Health Care |
| D010043 | Outcome and Process Assessment, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
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| Behavioral |
Patients will be observed during awake periods and during natural sleep. |
|
| Suresnes |
| Hauts de Seine |
| 92151 |
| France |