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NCT02841592 Clinical Trial

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

Acute Respiratory Failure Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02841592
Other study ID # 16-preox_3
Secondary ID
Status Completed
Phase N/A
First received July 18, 2016
Last updated January 28, 2018
Start date July 2016
Est. completion date August 2016

Study information
Verified date January 2018
Source Minneapolis Medical Research Foundation
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 27
Est. completion date August 2016
Est. primary completion date August 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Age >17

Exclusion Criteria:

- Pregnant

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

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Flush 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.
• Flush 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.

Locations
Country Name City State
United States Hennepin County Medical Center Minneapolis Minnesota

Sponsors (1)
Lead Sponsor Collaborator
Minneapolis Medical Research Foundation

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Fraction of expired oxygen The fraction of expired oxygen will be measured after three minutes of preoxygenation 3 minutes
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