At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Comparison of Pharyngeal Oxygen Delivery by Different Oxygen Masks
In Brief
An observational study evaluating Oxygen administration for Hypoxemia and 2 related conditions. Completed, enrolled 14 participants across 1 site.
Detailed Summary
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%.
Study Details
Timeline
Interventions
Subjects will breathe room air for 90 seconds. FiO2 will be measured for 30 seconds. Testing of masks will be performed with oxygen set at high flow through simple mask, non-rebreather mask, OxyMaskTM, and anesthesia mask with headstrap and Jackson-Rees circuit. After placement of each mask and starting oxygen, subjects will breathe normally for 90 seconds. FiO2 will be measured for 30 seconds. After each trial, subjects will take one vital capacity breath. Between testing each mask, subjects will breathe room air for 5 minutes to confirm stability of hemodynamic status. Respiratory rate and FiO2 data will be recorded during each breath to determine oxygen percentages. At the end of the 30 second sampling period, a final measurement will be taken during a forced vital capacity breath.