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Four methods of preoxygenation will be compared in healthy volunteers
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Preoxygenation | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Preoxygenation | Device | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27522310 | Derived | 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. |
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There were 26 total subjects; each did all 4 arms.
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| ID | Title | Description |
|---|---|---|
| FG000 | Preoxygenation | 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 60 L/min for 3 minutes 4) Bag valve mask at 15 L/min for 3 minutes |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Preoxygenation | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | 95% Confidence Interval | % FeO2 | Immediately after 3 minutes of oxygen supplementation |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Simple Mask | Simple mask at 60 L/min for 3 minutes Simple mask at 60 L/min: After 3 minutes of oxygen supplementation (preoxygenation), with each of the devices listed in the arms above, the exhaled oxygen content will be measured. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Audrey Hendrickson | HHRI | 6128737448 | audrey.hendrickson@hcmed.org |
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| ID | Term |
|---|---|
| D012131 | Respiratory Insufficiency |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
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| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| 0 |
| 26 |
| 0 |
| 26 |
| EG001 | Non-rebreather at 15 L/Min | Non-rebreather at 60 L/min Non-rebreather at 15 L/min: After 3 minutes of oxygen supplementation (preoxygenation), with each of the devices listed in the arms above, the exhaled oxygen content will be measured. | 0 | 26 | 0 | 26 |
| EG002 | Non-rebreather at 60 L/Min | Non-rebreather at 60 L/min for 3 minutes Non-rebreather at 60 L/min: After 3 minutes of oxygen supplementation (preoxygenation), with each of the devices listed in the arms above, the exhaled oxygen content will be measured. | 0 | 26 | 0 | 26 |
| EG003 | Bag Valve Mask at 15 L/Min | Bag valve mask at 15 L/min for 3 minutes Bag valve mask at 15 L/min: After 3 minutes of oxygen supplementation (preoxygenation), with each of the devices listed in the arms above, the exhaled oxygen content will be measured. | 0 | 26 | 0 | 26 |
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