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

University of California Irvine (UCI)

Status and phase: Completed; Phase 1

Conditions: Cerebral Ischemia

Treatments: Device: CDI 1000 COM

Study type: Interventional

Funder types: Other

Identifiers

NCT00598819

2007-5593

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 14 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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14 participants in 1 patient group

Healthy Volunteers

Experimental group

Description:

Healthy subjects testing the device.

Treatment:

Device: CDI 1000 COM