Trial Outcomes & Findings for Comparison of Pharyngeal Oxygen Delivery by Different Oxygen Masks (NCT NCT02523586)

Last Updated: 2018-08-01

Results Overview

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).

Recruitment status

COMPLETED

Target enrollment

14 participants

Primary outcome timeframe

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

Results posted on

2018-08-01

Participant Flow

University Hospital, OR

Participant milestones

Participant milestones
Measure	Oxygen Administration Via Simple Mask, Via Non-rebreather, Via OxyMask, Via Anesthesia Mask (head strap and J-R circuit), Via Room Air 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.
Overall Study STARTED	14
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Comparison of Pharyngeal Oxygen Delivery by Different Oxygen Masks

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Oxygen Administration n=10 Participants Via Simple Mask, Via Non-rebreather, Via OxyMask, Via Anesthesia Mask (head strap and J-R circuit), Via Room Air 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.
Age, Continuous	34.6 years STANDARD_DEVIATION 5.2 • n=93 Participants
Sex: Female, Male Female	4 Participants n=93 Participants
Sex: Female, Male Male	6 Participants n=93 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants
Race (NIH/OMB) Asian	1 Participants n=93 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=93 Participants
Race (NIH/OMB) Black or African American	1 Participants n=93 Participants
Race (NIH/OMB) White	6 Participants n=93 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=93 Participants
Region of Enrollment United States	10 participants n=93 Participants

PRIMARY outcome

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

Population: FiO2 at the lips

Outcome measures

Outcome measures
Measure	Simple Mask n=10 Participants At the lips	Closed Mask n=10 Participants At the lips	Non Rebreather Mask n=10 Participants At the lips	OxyMask n=10 Participants At the lips
Oxygen Concentration Measured at the Lips by Datex-Ohmeda Differential Paramagnetic Sensor	66.6 percentage of oxygen Interval 61.8 to 71.4	97.1 percentage of oxygen Interval 92.3 to 100.0	81.2 percentage of oxygen Interval 80.6 to 90.3	81.2 percentage of oxygen Interval 76.4 to 86.0

PRIMARY outcome

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

Outcome measures

Outcome measures
Measure	Simple Mask n=10 Participants At the lips	Closed Mask n=10 Participants At the lips	Non Rebreather Mask n=10 Participants At the lips	OxyMask n=10 Participants At the lips
Oxygen Concentration Measured at the Oropharyngeal Location by Nasal Catheter	62.3 percentage of oxygen Interval 57.5 to 67.1	96.8 percentage of oxygen Interval 91.9 to 100.0	76.3 percentage of oxygen Interval 71.5 to 81.1	50.9 percentage of oxygen Interval 46.1 to 55.8

Adverse Events

Oxygen Administration

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Jeffrey Kirsch

Oregon Health and Science University

Phone: 503-494-9000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place