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Non-rebreather at Flush Rate Compared to Bag Valve Mask With Assist

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02841592
Enrollment
27
Registered
2016-07-22
Start date
2016-07-31
Completion date
2016-08-31
Last updated
2018-01-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Respiratory Failure

Brief summary

This crossover investigation enrolls healthy volunteers and compares the exhaled oxygen content (FeO2) between the non-rebreather mask at the flush rate and a bag-valve-mask device at the flush rate, used with active positive pressure assistance.

Interventions

OTHERFlush rate oxygen

Using a standard flowmeter (Precision Medical, 8MFA), the flow of oxygen will be fully opened and oxygen will be administered for three minutes.

OTHERFlush rate oxygen with assist

Using a standard flowmeter (Precision Medical, 8MFA), the flow of oxygen will be fully opened and oxygen will be administered for three minutes. Positive pressure breaths to match the subject's inspiration will be provided during the three minute period.

Sponsors

Hennepin Healthcare Research Institute
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Age \>17

Exclusion criteria

* Pregnant * Any facial hair more than stubble that might impede a mask seal

Design outcomes

Primary

MeasureTime frameDescription
Fraction of expired oxygen3 minutesThe fraction of expired oxygen will be measured after three minutes of preoxygenation

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026