Four Methods of Pre-oxygenation
Comparison of Emergency Department Preoxygenation Techniques in Healthy Volunteers
1 other identifier
interventional
26
0 countries
N/A
Brief Summary
Four methods of preoxygenation will be compared in healthy volunteers
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2016
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2016
CompletedFirst Submitted
Initial submission to the registry
March 4, 2016
CompletedFirst Posted
Study publicly available on registry
March 15, 2016
CompletedResults Posted
Study results publicly available
June 18, 2019
CompletedJune 18, 2019
May 1, 2019
Same day
March 4, 2016
April 26, 2019
May 28, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
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.
Immediately after 3 minutes of oxygen supplementation
Study Arms (1)
Preoxygenation
EXPERIMENTALAll 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
Interventions
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
Eligibility Criteria
You may qualify if:
- Over 18 years old
You may not qualify if:
- Any active respiratory pathology (asthma, chronic obstructive pulmonary disease, other lung disease, smoking history more than 5 years)
- pregnant
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
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.
PMID: 27522310DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Audrey Hendrickson
- Organization
- HHRI
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Research Director
Study Record Dates
First Submitted
March 4, 2016
First Posted
March 15, 2016
Study Start
March 1, 2016
Primary Completion
March 1, 2016
Study Completion
March 1, 2016
Last Updated
June 18, 2019
Results First Posted
June 18, 2019
Record last verified: 2019-05