A Prospective Study of a New Device for Monitoring Cerebral Oxygenation on Healthy Volunteers

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-10-31

Study Completion Date

2009-05-31

Brief Summary

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The purpose of this study is to determine whether a new cerebral oxygen monitoring device is effective and comparatively similar to the current approved devices.

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Detailed Description

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Cerebral oxygenation monitoring is an innovative way to monitoring cardiac surgery patients intraoperatively to reduce the incidence of postoperative hypoxic side effects. There are a number of approved devices already in the market that have proved their effectivity.

Conditions

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Cerebral Ischemia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Healthy Volunteers

Healthy subjects testing the device.

Group Type EXPERIMENTAL

CDI 1000 COM

Intervention Type DEVICE

CDI 1000 COM sensors were attached to subject's forehead for a 12 hour period.

Interventions

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CDI 1000 COM

CDI 1000 COM sensors were attached to subject's forehead for a 12 hour period.

Intervention Type DEVICE

Other Intervention Names

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Terumo CDI 1000 COM

Eligibility Criteria

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Inclusion Criteria

* Healthy male or Female Volunteers
* 18 years old or older
* Capable and willing to operate a bicycle
* Understand enough about the risks and benefits of the study to be able to make an informed decision before agreeing to be in the study

EXLUSION CRITERIA:

* History of Cerebrovascular Disease
* History of Skin Problems on Forehead (Skin Rashes, Acne, Allergies, etc.)
* Pregnancy

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes