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

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ClinicalTrials.gov Identifier: NCT02841592
Recruitment Status : Completed
First Posted : July 22, 2016
Last Update Posted : January 30, 2018
Sponsor:
Information provided by (Responsible Party):
Brian Driver, Hennepin Healthcare Research Institute

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.

Condition or disease Intervention/treatment Phase
Acute Respiratory Failure Other: Flush rate oxygen Other: Flush rate oxygen with assist Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Actual Study Start Date : July 2016
Actual Primary Completion Date : August 2016
Actual Study Completion Date : August 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oxygen Therapy

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

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
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.




Primary Outcome Measures :
  1. Fraction of expired oxygen [ Time Frame: 3 minutes ]
    The fraction of expired oxygen will be measured after three minutes of preoxygenation



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age >17

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02841592


Locations
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United States, Minnesota
Hennepin County Medical Center
Minneapolis, Minnesota, United States, 55415
Sponsors and Collaborators
Hennepin Healthcare Research Institute
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Brian Driver, Associate Research Director, Hennepin Healthcare Research Institute
ClinicalTrials.gov Identifier: NCT02841592    
Other Study ID Numbers: 16-preox_3
First Posted: July 22, 2016    Key Record Dates
Last Update Posted: January 30, 2018
Last Verified: January 2018
Additional relevant MeSH terms:
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Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases