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

Hypoxemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01477450
• Other study ID #: Branson-2010-02
• Status: Completed
• Phase: N/A
• First received: November 18, 2011
• Last updated: September 24, 2014
• Start date: October 2011
• Est. completion date: September 2012

Study information

• Verified date: September 2014
• Source: University of Cincinnati
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: September 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypobaric Hypoxemia
• Hypoxemia

Intervention

Device:
• Pulse-dose oxygen
Pulsed-dose oxygen delivery from an oxygen concentrator
• Cylinder oxygen delivery
Oxygen delivery from an oxygen cylinder

Locations

Country	Name	City	State
United States	Brooks City Base	San Antonio	Texas

Sponsors (2)

Lead Sponsor	Collaborator
University of Cincinnati	United States Air Force

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	50 minutes	No