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Comparison of Pharyngeal Oxygen Delivery by Different Oxygen Masks

NCT02523586 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 14

Last updated 2018-08-01

Study results available
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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%.

Conditions

  • Hypoxemia
  • Trauma
  • Acute Myocardial Infarction

Interventions

OTHER

Oxygen administration

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.

Sponsors & Collaborators

  • Oregon Health and Science University

    lead OTHER

Principal Investigators

  • Jeffrey Kirsch, MD · Oregon Health and Science University

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-05-31
Primary Completion
2016-06-30
Completion
2016-06-30

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02523586 on ClinicalTrials.gov