CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 23 enrolled
Drug / intervention
Reduction of inspired oxygendevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01762722
NCT01762722N/ACompleted

Calibration and Validation of the 4 Wavelength Nonin Non-invasive Cerebral Oxygen Saturation Oximeter and Cerebral Sensor

Duke University·interventional·Posted Jan 8, 2013·Updated Apr 16, 2013

In Brief

A clinical study evaluating Reduction of inspired oxygen for Healthy. Completed, enrolled 23 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

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesUnited States
CollaboratorsNonin Medical, Inc

Timeline

N/ACompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedJan 8, 2013
Enrollment StartSep 1, 2009
Primary CompletionJun 1, 2010
Study CompletionApr 1, 2012
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 13.5 years ago

Interventions

Reduction of inspired oxygendevice

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%.