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| Name | Class |
|---|---|
| United States Air Force | FED |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 L/min ; 16 mL | Active Comparator | Cylinder oxygen delivery (1 L/min) followed by pulse-dose oxygen by concentrator (16 mL) |
|
| 2 L/min ; 32 mL | Active Comparator | Cylinder oxygen delivery (2 L/min) followed by pulse-dose oxygen by concentrator (32 mL) |
|
| 3 L/min ; 48 mL | Active Comparator | Cylinder oxygen delivery (3 L/min) followed by pulse-dose oxygen by concentrator (48 mL) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pulse-dose oxygen | Device | Pulsed-dose oxygen delivery from an oxygen concentrator |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 50 minutes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Richard Branson, MSc RRT | University of Cincinnati | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brooks City Base | San Antonio | Texas | 78235 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| FG002 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | 2 L/Min ; 32 mL |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| 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 | 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. | Number | participants | 50 minutes |
|
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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 | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Richard Branson | University of Cincinnati | bransord@uc.edu |
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| ID | Term |
|---|---|
| D000860 | Hypoxia |
| ID | Term |
|---|---|
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Cylinder oxygen delivery | Device | Oxygen delivery from an oxygen cylinder |
|
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 |
| BG002 | 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 |
| BG003 | Total | Total of all reporting groups |
| participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
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 |
| OG002 | 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 |
|
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| EG001 | 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 | 0 | 10 | 0 | 10 |
| EG002 | 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 | 0 | 10 | 0 | 10 |
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