Comparison of Pharyngeal Oxygen Delivery by Different Oxygen Masks

Completed

Conditions studied: Hypoxemia, Trauma, Acute Myocardial Infarction

In brief

The intent of this study is to determine the difference in pharyngeal oxygen concentration in patients who have a natural airway (not intubated) using commonly available oxygen delivery systems. The investigators will test the hypothesis that oxygen concentration during the period of inspiration (FiO2) in the pharynx is dependent on oxygen delivery system design, even at high flow (15 liters/minute) oxygen delivery. Specific measurements include oxygen concentration at subjects' lips and pharynx when breathing 100% oxygen and room air via a simple mask, non-rebreather mask, OxyMaskTM, and anesthesia mask with headstrap and Jacson Rees circuit. A mean difference of 10% pharyngeal FiO2 between any of the masks will be considered clinically important. The expected standard deviation of the within-subject FiO2 is 3.5%. With a significance criterion of 0.05, 10 subjects would provide more than 90% power to detect a mean difference of 10%.

Key facts

Study ID

NCT02523586

Run by

Oregon Health and Science University

People needed

14

Starts

2015-05-01

Expected to finish

2016-06-01

Last updated by the study team

2018-08-01

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 18 to 70 years of age
• Male and female volunteers
• ASA physical status I, II and III
• Capable and willing to provide written informed consent in English

You may not qualify if…

• Acute cardiopulmonary disease, as defined by blood pressure greater than 150/90, HR greater than 120 and room air oxygen saturation less than 92.
• Allergy to lidocaine or adhesive tape
• History or physical exam finding of nasal polyps
• Currently taking oral or parenteral anticoagulant medications (other than aspirin)
• History of frequent nose bleeds
• Current symptoms of nasal congestion
• Physical examination findings of rales or wheezing
• Facial hair that prevents forming a seal with an anesthesia mask

Where it is running

• Oregon Health and Science University — Portland, Oregon, United States

Full record on ClinicalTrials.gov

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