Comparison of Oxygen Delivery Devices for Reversal of Altitude-Induced Hypoxemia in Normal Subjects

University of Cincinnati

Status: Completed

Conditions: Hypobaric Hypoxemia; Hypoxemia

Treatments: Device: Pulse-dose oxygen; Device: Cylinder oxygen delivery

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT01477450

Branson-2010-02

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 3 patient groups

1 L/min ; 16 mL

Active Comparator group

Description:

Cylinder oxygen delivery (1 L/min) followed by pulse-dose oxygen by concentrator (16 mL)

Treatment:

Device: Pulse-dose oxygen

Device: Cylinder oxygen delivery

2 L/min ; 32 mL

Active Comparator group

Description:

Cylinder oxygen delivery (2 L/min) followed by pulse-dose oxygen by concentrator (32 mL)

Treatment:

Device: Pulse-dose oxygen

Device: Cylinder oxygen delivery

3 L/min ; 48 mL

Active Comparator group

Description:

Cylinder oxygen delivery (3 L/min) followed by pulse-dose oxygen by concentrator (48 mL)

Treatment:

Device: Pulse-dose oxygen

Device: Cylinder oxygen delivery