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CompletedNCT02841592Updated Jan 30, 2018

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

An interventional study of Flush rate oxygen and Flush rate oxygen with assist in Acute Respiratory Failure, sponsored by Hennepin Healthcare Research Institute. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-01-30.

Sponsored by Hennepin Healthcare Research Institute · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
27
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Acute Respiratory Failure
03

In context

Respiratory Insufficiency

1,650 studies on the registry are indexed under Respiratory Insufficiency; 296 are open to participants now.

This study's enrollment of 27 is below the median of 55 across 1,043 interventional studies indexed under Respiratory Insufficiency.

Browse Respiratory Insufficiency studies →

Lead sponsor

Hennepin Healthcare Research Institute is the lead sponsor of 69 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Age >17

Exclusion criteria

Exclusion Criteria:

  • Pregnant
  • Any facial hair more than stubble that might impede a mask seal
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
27 participants (actual)

Study arms

  • Active comparator
    Non-rebreather

    This group will have a non-rebreather mask applied to the face and they will receive the flush rate oxygen intervention

    Other: Flush rate oxygen

  • Active comparator
    Bag-valve-mask

    With each inspiration from the subject, the ventilation bag will be gently squeezed to provide positive pressure and augment the amount of oxygen that is received by the subject for each breath. This group will receive the flush rate oxygen with assist intervention.

    Other: Flush rate oxygen with assist

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.

06

What researchers measure

Primary outcomes

  1. Fraction of expired oxygen

    The fraction of expired oxygen will be measured after three minutes of preoxygenation

    Time frame: 3 minutes

07

Study locations

1 site
  • Hennepin County Medical Center
    Minneapolis, Minnesota 55415, United States
08

References and documents

Publications

  • Driver BE, Klein LR, Carlson K, Harrington J, Reardon RF, Prekker ME. Preoxygenation With Flush Rate Oxygen: Comparing the Nonrebreather Mask With the Bag-Valve Mask. Ann Emerg Med. 2018 Mar;71(3):381-386. doi: 10.1016/j.annemergmed.2017.09.017. Epub 2017 Oct 28. PubMed 29089172 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 30, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02841592
Lead sponsor
Hennepin Healthcare Research Institute
Responsible party
Brian Driver (Associate Research Director, Hennepin Healthcare Research Institute) — Principal investigator
First posted
Jul 22, 2016
Start date
Jul 2016
Primary completion
Aug 2016
Completion
Aug 2016
Last update
Jan 30, 2018

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.

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