Validation of Brain Oxygenation Monitor

Completed · Not applicable

Conditions studied: Healthy

In brief

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 pulse oximeter. The cerebral oximeter consists of a sensor placed on the forehead that both emits and detects the amount of light absorbed. This study will determine how accurate the device is by comparing the displayed value on the monitor with blood samples taken simultaneously from the arterial blood in the wrist and venous blood in the neck. In order to test the device over a suitable range, the level of oxygen within the blood will be reduced in a controlled manner by reduction of the inspired oxygen concentration. This is the equivalent of ascending to an altitude of 16,000 feet. The study will be conducted in healthy volunteers.

Key facts

Study ID

NCT00815490

Run by

Duke University

People needed

18

Starts

2008-06-01

Expected to finish

2012-04-01

Last updated by the study team

2013-04-16

Who can join

Age: 21 and older, up to 35. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 21 to 35 years
• American Society of Anesthesiologists health assessment level 1
• Body Mass Index (BMI) 18 to 30

You may not qualify if…

• 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

Where it is running

• Duke University Health System — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.