Status:
COMPLETED
Validation of Brain Oxygenation Monitor
Lead Sponsor:
Duke University
Collaborating Sponsors:
Nonin Medical, Inc
Conditions:
Healthy
Eligibility:
All Genders
21-35 years
Phase:
NA
Brief Summary
A cerebral oximeter is a device that uses light to measure the amount of oxygen within the brain. It is similar to the device that measures the level of oxygen in the tip of the finger, known as a pul...
Detailed Description
This is a calibration and validation study of a near-infrared spectroscopy (NIRS) device designed to measure the cerebral tissue oxygen saturation non-invasively. This is achieved by comparing NIRS-de...
Eligibility Criteria
Inclusion
- 21 to 35 years
- American Society of Anesthesiologists health assessment level 1
- Body Mass Index (BMI) 18 to 30
Exclusion
- anemia
- hemoglobinopathy (e.g. sickle cell disease, thalassemia)
- positive pregnancy test (females)
- significant cardiac or pulmonary disease
- history of sleep apnea
- tobacco, drug or alcohol abuse
- difficult airway
- abnormal EKG / pulmonary function test / room air saturation
- intolerance to breathing mask apparatus
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2012
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT00815490
Start Date
June 1 2008
End Date
April 1 2012
Last Update
April 16 2013
Active Locations (1)
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1
Duke University Health System
Durham, North Carolina, United States, 27705