N/A N=14

Comparison of Pharyngeal Oxygen Delivery by Different Oxygen Masks

Hypoxemia · Trauma · Acute Myocardial Infarction

Bottom Line

View on ClinicalTrials.gov: NCT02523586 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Aug 2018

Primary outcome: Primary: Oxygen Concentration Measured at the Lips by Datex-Ohmeda Differential Paramagnetic Sensor — 66.6; 97.1; 81.2; 81.2 percentage of oxygen

Study Design & Population

Study type: Observational
Phase: N/A
Interventions: Oxygen administration (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Oregon Health and Science University
Primary completion: Jun 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY Oxygen Concentration Measured at the Lips by Datex-Ohmeda Differential Paramagnetic Sensor	66.6; 97.1; 81.2; 81.2	—
PRIMARY Oxygen Concentration Measured at the Oropharyngeal Location by Nasal Catheter	62.3; 96.8; 76.3; 50.9	—

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%.

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02523586). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.