Non-rebreather at Flush Rate Compared to Bag Valve Mask With Assist
1 other identifier
interventional
27
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jul 2016
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2016
CompletedFirst Submitted
Initial submission to the registry
July 18, 2016
CompletedFirst Posted
Study publicly available on registry
July 22, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2016
CompletedJanuary 30, 2018
January 1, 2018
1 month
July 18, 2016
January 28, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Fraction of expired oxygen
The fraction of expired oxygen will be measured after three minutes of preoxygenation
3 minutes
Study Arms (2)
Non-rebreather
ACTIVE COMPARATORThis group will have a non-rebreather mask applied to the face and they will receive the flush rate oxygen intervention
Bag-valve-mask
ACTIVE COMPARATORWith 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.
Interventions
Using a standard flowmeter (Precision Medical, 8MFA), the flow of oxygen will be fully opened and oxygen will be administered for three minutes.
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.
Eligibility Criteria
You may qualify if:
- Age \>17
You may not qualify if:
- Pregnant
- Any facial hair more than stubble that might impede a mask seal
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hennepin County Medical Center
Minneapolis, Minnesota, 55415, United States
Related Publications (1)
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.
PMID: 29089172DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Research Director
Study Record Dates
First Submitted
July 18, 2016
First Posted
July 22, 2016
Study Start
July 1, 2016
Primary Completion
August 1, 2016
Study Completion
August 1, 2016
Last Updated
January 30, 2018
Record last verified: 2018-01