Skip to main content
OpenTrials
Completed

NCT Number: NCT01477450

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hypoxemia Hypobaric Hypoxemia Hypoxia Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Respiratory

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Brooks City Base

San Antonio, Texas, 78235, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pulse-dose oxygen

Device

Pulsed-dose oxygen delivery from an oxygen concentrator

Cylinder oxygen delivery

Device

Oxygen delivery from an oxygen cylinder

Primary outcomes

  1. Return of Oxygen Saturation to Baseline (Sea Level) Values

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Cincinnati

Other

Collaborators

  • United States Air Force

Registry information

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Nov 22, 2011
Registry last updated
Sep 26, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.