Back to resultsBag Valve Mask vs Non-rebreather at Flush Rate
Primary Purpose
Respiratory Failure
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Flush rate oxygen using a standard flowmeter (Precision Medical, 8MFA). See description for details. This is specific.
Sponsored by
About this trial
This is an interventional other trial for Respiratory Failure
Eligibility Criteria
Inclusion Criteria:
- Age >17
Exclusion Criteria:
- Pregnant
- Any facial hair more than stubble that might impede a mask seal
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
Non rebreather
Bag valve mask without leak
Bag valve mask with simulated mask leak
Arm Description
Outcomes
Primary Outcome Measures
Fraction of expired oxygen
The fraction of expired oxygen will be measured after three minutes of preoxygenation
Secondary Outcome Measures
Full Information
NCT ID
NCT02798302
First Posted
June 6, 2016
Last Updated
January 28, 2018
Sponsor
Hennepin Healthcare Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT02798302
Brief Title
Bag Valve Mask vs Non-rebreather at Flush Rate
Official Title
Preoxygenation With a Bag Valve Mask vs Non-rebreather at Flush Rate
Study Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
June 2016 (undefined)
Primary Completion Date
September 2016 (Actual)
Study Completion Date
September 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hennepin Healthcare Research Institute
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Healthy volunteers will participate in a crossover trial comparing preoxygenation with a non-rebreather mask to a bag-valve mask (with and without a simulated mask leak) at the flush rate of oxygen (fully opening standard oxygen flowmeter).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Failure
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Non rebreather
Arm Type
Active Comparator
Arm Title
Bag valve mask without leak
Arm Type
Active Comparator
Arm Title
Bag valve mask with simulated mask leak
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Flush rate oxygen using a standard flowmeter (Precision Medical, 8MFA). See description for details. This is specific.
Intervention Description
A standard oxygen flowmeter will be fully opened and oxygen will be administered for three minutes.
Primary Outcome Measure Information:
Title
Fraction of expired oxygen
Description
The fraction of expired oxygen will be measured after three minutes of preoxygenation
Time Frame
3 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Age >17
Exclusion Criteria:
Pregnant
Any facial hair more than stubble that might impede a mask seal
12. IPD Sharing Statement
Learn more about this trial
Bag Valve Mask vs Non-rebreather at Flush Rate
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