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Validation of Brain Oxygenation Monitor

NCT00815490 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2013-04-16

Study results available
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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.

Conditions

  • Healthy

Interventions

DEVICE

Desaturation

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%.

Sponsors & Collaborators

Principal Investigators

  • David B MacLeod, FRCA · Duke Health

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Max Age
35 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-06-30
Primary Completion
2008-11-30
Completion
2012-04-30

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00815490 on ClinicalTrials.gov