Status:
COMPLETED
Accuracy of the O2 MedTech PMS-3000 Monitor
Lead Sponsor:
O2 MedTech, Inc.
Collaborating Sponsors:
Duke University
Conditions:
Healthy
Eligibility:
All Genders
18-50 years
Phase:
PHASE2
Brief 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 pul...
Detailed Description
This is a calibration and validation study of a near-infrared spectroscopy (NIRS) device designed to measure the cerebral tissue oxygen saturation non-invasively. This is achieved by comparing NIRS-de...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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)
Key Trial Info
Start Date :
August 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2012
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT01418079
Start Date
August 1 2011
End Date
February 1 2012
Last Update
May 23 2012
Active Locations (1)
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1
Duke University Medical Center
Durham, North Carolina, United States, 27705