Respiratory Failure
Conditions
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
Interventions
DEVICEPreoxygenation
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
Sponsors
Hennepin Healthcare Research Institute
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Exhaled Oxygen Concentration | Immediately after 3 minutes of oxygen supplementation | 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. |
Participant flow
Pre-assignment details
There were 26 total subjects; each did all 4 arms.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 26 |
| Total | 26 |
Baseline characteristics
| Characteristic | Preoxygenation |
|---|---|
| Age, Continuous | 26 years STANDARD_DEVIATION 6 |
| Region of Enrollment United States | 26 participants |
| Sex: Female, Male Female | 13 Participants |
| Sex: Female, Male Male | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 26 | 0 / 26 | 0 / 26 | 0 / 26 |
| serious Total, serious adverse events | 0 / 26 | 0 / 26 | 0 / 26 | 0 / 26 |
Outcome results
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.
Time frame: Immediately after 3 minutes of oxygen supplementation
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Preoxygenation | Exhaled Oxygen Concentration | Simple mask at 60 L/min for 3 minutes | 72 % FeO2 |
| Preoxygenation | Exhaled Oxygen Concentration | Non-rebreather at 60 L/min for 3 min | 86 % FeO2 |
| Preoxygenation | Exhaled Oxygen Concentration | Non-rebreather at 15 L/min for 3 min | 54 % FeO2 |
| Preoxygenation | Exhaled Oxygen Concentration | Bag valve mask at 15 L/min for 3 minutes | 77 % FeO2 |