Comparison of Pharyngeal Oxygen Delivery by Different Oxygen Masks

NCT02523586 | Completed Results

• 1 other identifier: 11231
• Study Type: observational
• Target: 14
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

oxygen concentration; oxygen therapy; oxygen delivery; oxygen masks

Outcome Measures

Primary Outcomes (2)

• Oxygen Concentration Measured at the Lips by Datex-Ohmeda Differential Paramagnetic Sensor

  After placement of each mask and starting oxygen high flow, the subject will breathe normally for 90 seconds and then FiO2 will be measured over the next 30 seconds. At the end of each trial period, each subject will be asked to take a single vital capacity breath (starting with maximum exhalation and followed by maximum inhalation). Between testing of each mask, there will be a 5 minute period of breathing room air as a washout period to confirm stability of hemodynamic status (measurement of blood pressure and heart rate).

  The subjects will each participate on one study day and will require 1 hour per subject.

• Oxygen Concentration Measured at the Oropharyngeal Location by Nasal Catheter

  After placement of each mask and starting oxygen high flow, the subject will breathe normally for 90 seconds and then FiO2 will be measured over the next 30 seconds. At the end of each trial period, each subject will be asked to take a single vital capacity breath (starting with maximum exhalation and followed by maximum inhalation). Between testing of each mask, there will be a 5 minute period of breathing room air as a washout period to confirm stability of hemodynamic status (measurement of blood pressure and heart rate).

  The subjects will each participate on one study day and will require 1 hour per subject.

Study Arms (1)

Oxygen administration

Via Simple Mask, Via Non-rebreather, Via OxyMask, Via Anesthesia Mask (head strap and J-R circuit), Via Room Air

Other: Oxygen administration

Interventions

Oxygen administration OTHER

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.

Also known as: Simple Mask, Non-rebreather mask, OxyMaskTM, Anesthesia mask with headstrap and Jackson-Rees circuit, Room air

Oxygen administration

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects who meet the inclusion criteria and none of the exclusion criteria who are to undergo a procedure not requiring general anesthesia.

You may qualify if:

• 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

Sponsors & Collaborators

• Oregon Health and Science University: lead

Study Sites (1)

Oregon Health and Science University

Portland, Oregon, 97239, United States

Location

Related Publications (6)

• Kallstrom TJ; American Association for Respiratory Care (AARC). AARC Clinical Practice Guideline: oxygen therapy for adults in the acute care facility--2002 revision & update. Respir Care. 2002 Jun;47(6):717-20. No abstract available.

  PMID: 12078655 BACKGROUND

• ACCP-NHLBI National Conference on Oxygen Therapy. Chest. 1984 Aug;86(2):234-47. doi: 10.1378/chest.86.2.234. No abstract available.

  PMID: 6744963 BACKGROUND

• Paul JE, Hangan H, Hajgato J. The OxyMask() development and performance in healthy volunteers. Med Devices (Auckl). 2009;2:9-17. Epub 2008 Dec 11.

  PMID: 22915909 BACKGROUND

• KORY RC, BERGMANN JC, SWEET RD, SMITH JR. Comparative evaluation of oxygen therapy techniques. JAMA. 1962 Mar 10;179:767-72. doi: 10.1001/jama.1962.03050100021005. No abstract available.

  PMID: 14458557 BACKGROUND

• Wettstein RB, Shelledy DC, Peters JI. Delivered oxygen concentrations using low-flow and high-flow nasal cannulas. Respir Care. 2005 May;50(5):604-9.

  PMID: 15871753 BACKGROUND

• Yanez ND, Fu AY, Treggiari MM, Kirsch JR. Oropharyngeal Oxygen Concentration Is Dependent on the Oxygen Mask System and Sampling Location. Respir Care. 2020 Jan;65(1):29-35. doi: 10.4187/respcare.07027. Epub 2019 Sep 10.

  PMID: 31506337 DERIVED

MeSH Terms

Conditions

Hypoxia; Wounds and Injuries

Interventions

Oxygen

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Chalcogens; Elements; Inorganic Chemicals; Gases

Results Point of Contact

• Title: Jeffrey Kirsch
• Organization: Oregon Health and Science University

kirschje@ohsu.edu

503-494-9000

Study Officials

• Jeffrey Kirsch, MD

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Chair

Study Record Dates

• First Submitted: July 20, 2015
• First Posted: August 14, 2015
• Study Start: May 1, 2015
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: August 1, 2018
• Results First Posted: August 1, 2018

Record last verified: 2017-10

Locations

US (1)