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Four Methods of Pre-oxygenation

Primary Purpose

Respiratory Failure

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Preoxygenation
Sponsored by
Hennepin Healthcare Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Respiratory Failure

Eligibility Criteria

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

Inclusion Criteria:

  • Over 18 years old

Exclusion Criteria:

  • Any active respiratory pathology (asthma, chronic obstructive pulmonary disease, other lung disease, smoking history more than 5 years)
  • pregnant

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Preoxygenation

    Arm Description

    All participants were enrolled in a single arm in which they underwent 4 interventions in series: 1) Simple mask at 60 L/min for 3 minutes 2) Non-rebreather at 15 L/min for 3 min 3) Non-rebreather at 60 L/min for 3 minutes 4) Bag valve mask at 15 L/min for 3 minutes

    Outcomes

    Primary Outcome Measures

    Exhaled Oxygen Concentration
    Subjects will blow into an oxygen sensor after each method (arm). The primary outcome will be a non-inferiority test between bag valve mask and non-rebreather at 60 L/min. The remaining tests will be completed for comparison, but not part of formal statistical testing.

    Secondary Outcome Measures

    Full Information

    First Posted
    March 4, 2016
    Last Updated
    May 28, 2019
    Sponsor
    Hennepin Healthcare Research Institute
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02708862
    Brief Title
    Four Methods of Pre-oxygenation
    Official Title
    Comparison of Emergency Department Preoxygenation Techniques in Healthy Volunteers
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2016 (undefined)
    Primary Completion Date
    March 2016 (Actual)
    Study Completion Date
    March 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
    Four methods of preoxygenation will be compared in healthy volunteers
    Detailed Description
    After informed consent, each volunteer will undergo the following techniques: Simple mask at "flush" flow (40-60 L/min) Non-rebreather mask at 15 L/min Non-rebreather mask at 60 L/min Bag valve mask with one way exhalation valve at 15 L/min After 3 minutes, the exhaled oxygen will be measured with an oxygen sensor

    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
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    26 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Preoxygenation
    Arm Type
    Experimental
    Arm Description
    All participants were enrolled in a single arm in which they underwent 4 interventions in series: 1) Simple mask at 60 L/min for 3 minutes 2) Non-rebreather at 15 L/min for 3 min 3) Non-rebreather at 60 L/min for 3 minutes 4) Bag valve mask at 15 L/min for 3 minutes
    Intervention Type
    Device
    Intervention Name(s)
    Preoxygenation
    Intervention Description
    After 3 minutes of oxygen supplementation (preoxygenation), with each of the devices listed below, the exhaled oxygen content will be measured. All participants were enrolled in a single arm in which they underwent 4 interventions in series: 1) Simple mask at 60 L/min for 3 minutes 2) Non-rebreather at 60 L/min for 3 min 3) Non-rebreather at 15 L/min for 3 minutes 4) Bag valve mask at 15 L/min for 3 minutes
    Primary Outcome Measure Information:
    Title
    Exhaled Oxygen Concentration
    Description
    Subjects will blow into an oxygen sensor after each method (arm). The primary outcome will be a non-inferiority test between bag valve mask and non-rebreather at 60 L/min. The remaining tests will be completed for comparison, but not part of formal statistical testing.
    Time Frame
    Immediately after 3 minutes of oxygen supplementation

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Over 18 years old Exclusion Criteria: Any active respiratory pathology (asthma, chronic obstructive pulmonary disease, other lung disease, smoking history more than 5 years) pregnant

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    Citations:
    PubMed Identifier
    27522310
    Citation
    Driver BE, Prekker ME, Kornas RL, Cales EK, Reardon RF. Flush Rate Oxygen for Emergency Airway Preoxygenation. Ann Emerg Med. 2017 Jan;69(1):1-6. doi: 10.1016/j.annemergmed.2016.06.018. Epub 2016 Aug 10.
    Results Reference
    derived

    Learn more about this trial

    Four Methods of Pre-oxygenation

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