Hypobaric Hypoxemia, Hypoxemia
Conditions
Keywords
Hypobaric hypoxemia, Altitude, Oxygen, oxygen concentrator
Brief summary
This study will compare the ability of pulsed-dose oxygen from a concentrator to reverse altitude-induced hypoxemia compared to compressed gas from a standard oxygen cylinder.
Detailed description
Subjects will be monitored non-invasively with pulse oximetry, end-tidal carbon dioxide, tissue oxygenation and ECG. The mean seal level oxygen saturation will be recorded.Subjects exposed to an altitude of 14,000 feet will experience moderate hypobaric hypoxia. The mean oxygen saturation at this altitude is 83%. Subjects will receive oxygen from both an oxygen concentrator or a cylinder of oxygen following exposure to hypobarism. Oxygen from each source will be increased in 1 liter per minute increments until the oxygen saturation returns to the baseline sea level oxygen saturation. The oxygen requirement to return oxygen saturation to baseline values will be recorded. The flow from the concentrator and the cylinder will be compared.
Interventions
DEVICEPulse-dose oxygen
Pulsed-dose oxygen delivery from an oxygen concentrator
DEVICECylinder oxygen delivery
Oxygen delivery from an oxygen cylinder
Sponsors
United States Air Force
University of Cincinnati
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* Current altitude chamber certification * Age 18 years - 60 years
Exclusion criteria
* Current upper respiratory infection * Current symptoms of lower respiratory infection -- productive cough
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Return of Oxygen Saturation to Baseline (Sea Level) Values | 50 minutes | Oxygen will be titrated from either an oxygen concentrator or an oxygen cylinder in liters per minute until the oxygen saturation returns to the sea level value. The flow in liters per minute is the dependent variables. Each participant will experience induced hypoxemia followed by cylinder oxygen delivery; each will also experience induced hypoxemia followed by pulse-dose oxygen from a concentrator. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 1 L/Min ; 16 mL Cylinder oxygen delivery (1 L/min) followed by pulse-dose oxygen by concentrator (16 mL)
Pulse-dose oxygen: Pulsed-dose oxygen delivery from an oxygen concentrator
Cylinder oxygen delivery: Oxygen delivery from an oxygen cylinder | 10 |
| 2 L/Min ; 32 mL Cylinder oxygen delivery (2 L/min) followed by pulse-dose oxygen by concentrator (32 mL)
Pulse-dose oxygen: Pulsed-dose oxygen delivery from an oxygen concentrator
Cylinder oxygen delivery: Oxygen delivery from an oxygen cylinder | 10 |
| 3 L/Min ; 48 mL Cylinder oxygen delivery (3 L/min) followed by pulse-dose oxygen by concentrator (48 mL)
Pulse-dose oxygen: Pulsed-dose oxygen delivery from an oxygen concentrator
Cylinder oxygen delivery: Oxygen delivery from an oxygen cylinder | 10 |
| Total | 30 |
Baseline characteristics
| Characteristic | 1 L/Min ; 16 mL | 2 L/Min ; 32 mL | 3 L/Min ; 48 mL | Total |
|---|---|---|---|---|
| Age, Customized 18-65 years | 10 participants | 10 participants | 10 participants | 30 participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants | 1 Participants | 6 Participants | 11 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 6 Participants | 9 Participants | 4 Participants | 19 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 1 Participants | 3 Participants | 2 Participants | 6 Participants |
| Sex: Female, Male Male | 9 Participants | 7 Participants | 8 Participants | 24 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 10 | 0 / 10 | 0 / 10 |
| serious Total, serious adverse events | 0 / 10 | 0 / 10 | 0 / 10 |
Outcome results
Primary
Return of Oxygen Saturation to Baseline (Sea Level) Values
Oxygen will be titrated from either an oxygen concentrator or an oxygen cylinder in liters per minute until the oxygen saturation returns to the sea level value. The flow in liters per minute is the dependent variables. Each participant will experience induced hypoxemia followed by cylinder oxygen delivery; each will also experience induced hypoxemia followed by pulse-dose oxygen from a concentrator.
Time frame: 50 minutes
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 1 L/Min ; 16 mL | Return of Oxygen Saturation to Baseline (Sea Level) Values | Reversal of hypoxemia after pulse-dose oxygen | 6 participants |
| 1 L/Min ; 16 mL | Return of Oxygen Saturation to Baseline (Sea Level) Values | Non-reversal of hypoxemia after pulse-dose oxygen | 4 participants |
| 1 L/Min ; 16 mL | Return of Oxygen Saturation to Baseline (Sea Level) Values | Reversal of hypoxemia after cylinder O2 delivery | 9 participants |
| 1 L/Min ; 16 mL | Return of Oxygen Saturation to Baseline (Sea Level) Values | Non-reversal of hypoxemia after cylinder O2 delive | 1 participants |
| 2 L/Min ; 32 mL | Return of Oxygen Saturation to Baseline (Sea Level) Values | Non-reversal of hypoxemia after cylinder O2 delive | 0 participants |
| 2 L/Min ; 32 mL | Return of Oxygen Saturation to Baseline (Sea Level) Values | Reversal of hypoxemia after pulse-dose oxygen | 8 participants |
| 2 L/Min ; 32 mL | Return of Oxygen Saturation to Baseline (Sea Level) Values | Reversal of hypoxemia after cylinder O2 delivery | 10 participants |
| 2 L/Min ; 32 mL | Return of Oxygen Saturation to Baseline (Sea Level) Values | Non-reversal of hypoxemia after pulse-dose oxygen | 2 participants |
| 3 L/Min ; 48 mL | Return of Oxygen Saturation to Baseline (Sea Level) Values | Non-reversal of hypoxemia after cylinder O2 delive | 0 participants |
| 3 L/Min ; 48 mL | Return of Oxygen Saturation to Baseline (Sea Level) Values | Non-reversal of hypoxemia after pulse-dose oxygen | 0 participants |
| 3 L/Min ; 48 mL | Return of Oxygen Saturation to Baseline (Sea Level) Values | Reversal of hypoxemia after cylinder O2 delivery | 10 participants |
| 3 L/Min ; 48 mL | Return of Oxygen Saturation to Baseline (Sea Level) Values | Reversal of hypoxemia after pulse-dose oxygen | 10 participants |
p-value: 0.3Chi-squared
p-value: 0.47Chi-squared
p-value: 1Chi-squared