At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Calibration and Validation of the Nonin Non-invasive Cerebral Oxygen Saturation Oximeter and Cerebral Sensor in Human Volunteers
In Brief
A clinical study evaluating Desaturation for Healthy. Completed, enrolled 18 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
Reduction in blood oxygen saturation by sequential reduction in inspired gas composition. Steps are of 6 minutes duration with reduction in pulse oximeter oxygen saturation from 100 to 70%.