Ignite Creation Date:
2025-12-24 @ 5:14 PM
Ignite Modification Date:
2025-12-27 @ 9:58 PM
Study NCT ID:
NCT01477450
Status:
COMPLETED
Last Update Posted:
2014-09-26
First Post:
2011-11-18
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Comparison of Oxygen Delivery Devices for Reversal of Altitude-Induced Hypoxemia in Normal Subjects
Sponsor:
University of Cincinnati
Organization:
Study Overview
Official Title:
Comparison of Oxygen Delivery Devices for Reversal of Altitude-Induced Hypoxemia in Normal Subjects
Status:
COMPLETED
Status Verified Date:
2014-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
The oxygen requirement to return oxygen saturation to baseline values will be recorded. The flow from the concentrator and the cylinder will be compared.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: