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

Primary Purpose

Acute Respiratory Failure

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Flush rate oxygen
Flush rate oxygen with assist
Sponsored by
Hennepin Healthcare Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Respiratory Failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Age >17

Exclusion Criteria:

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

Sites / Locations

  • Hennepin County Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Non-rebreather

Bag-valve-mask

Arm Description

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

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.

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

First Posted
July 18, 2016
Last Updated
January 28, 2018
Sponsor
Hennepin Healthcare Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT02841592
Brief Title
Non-rebreather at Flush Rate Compared to Bag Valve Mask With Assist
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
July 2016 (Actual)
Primary Completion Date
August 2016 (Actual)
Study Completion Date
August 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Respiratory Failure

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
27 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Non-rebreather
Arm Type
Active Comparator
Arm Description
This group will have a non-rebreather mask applied to the face and they will receive the flush rate oxygen intervention
Arm Title
Bag-valve-mask
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Flush rate oxygen
Intervention Description
Using a standard flowmeter (Precision Medical, 8MFA), the flow of oxygen will be fully opened and oxygen will be administered for three minutes.
Intervention Type
Other
Intervention Name(s)
Flush rate oxygen with assist
Intervention Description
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 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
Facility Information:
Facility Name
Hennepin County Medical Center
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55415
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
29089172
Citation
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.
Results Reference
derived

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

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