N/A
N=18
Validation of Brain Oxygenation Monitor
Healthy
Bottom Line
View on ClinicalTrials.gov: NCT00815490 ↗Enrolled (actual)
18
Serious AEs
0.0%
Results posted
Apr 2013
Primary outcome: Primary: Accuracy of Sensor — 3.0; 8.1 percentage saturation
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Desaturation (Device)
- Age
- Adult · 21+ yrs
- Sex
- All
- Sponsor
- Duke University
- Primary completion
- Nov 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Accuracy of Sensor |
3.0; 8.1 | — |
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 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.
Eligibility Criteria
Inclusion Criteria
- 21 to 35 years
- American Society of Anesthesiologists health assessment level 1
- Body Mass Index (BMI) 18 to 30
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT00815490). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.