Accuracy of the O2 MedTech PMS-3000 Monitor

Completed · Phase 2

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

NCT01418079

Run by

O2 MedTech, Inc.

People needed

42

Starts

2011-08-01

Expected to finish

2012-02-01

Last updated by the study team

2012-05-23

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Body Mass Index (BMI) of 18 to 30, inclusive
• No anticoagulant or platelet inhibitor use
• Oxygen saturation (SpO2) ≥ 95% on room air
• Able to tolerate breathing mask apparatus

You may not qualify if…

• Female with positive pregnancy test
• Beard or history of or anatomy suggestive of difficult airway
• Lab values outside normal range for the clinical site
• History of cigarette smoking or currently a cigarette smoker
• Current drug or alcohol abuse
• History of sleep apnea, high blood pressure (HBP), cardiac or pulmonary disease, gastroesophageal reflux, hemoglobinopathy, or coagulation abnormality
• Known allergy to lidocaine or heparin
• Abnormal electrocardiogram (ECG)

Where it is running

• Duke University Medical Center — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

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