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

NCT ID: NCT01477450

Last Updated: 2014-09-26

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2012-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hypoxemia Hypobaric Hypoxemia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1 L/min ; 16 mL

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

Group Type ACTIVE_COMPARATOR

Pulse-dose oxygen

Intervention Type DEVICE

Pulsed-dose oxygen delivery from an oxygen concentrator

Cylinder oxygen delivery

Intervention Type DEVICE

Oxygen delivery from an oxygen cylinder

2 L/min ; 32 mL

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

Group Type ACTIVE_COMPARATOR

Pulse-dose oxygen

Intervention Type DEVICE

Pulsed-dose oxygen delivery from an oxygen concentrator

Cylinder oxygen delivery

Intervention Type DEVICE

Oxygen delivery from an oxygen cylinder

3 L/min ; 48 mL

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

Group Type ACTIVE_COMPARATOR

Pulse-dose oxygen

Intervention Type DEVICE

Pulsed-dose oxygen delivery from an oxygen concentrator

Cylinder oxygen delivery

Intervention Type DEVICE

Oxygen delivery from an oxygen cylinder

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Pulse-dose oxygen

Pulsed-dose oxygen delivery from an oxygen concentrator

Intervention Type DEVICE

Cylinder oxygen delivery

Oxygen delivery from an oxygen cylinder

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

United States Air Force

FED

Sponsor Role collaborator

University of Cincinnati

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Rich Branson, M.D.

Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Richard Branson, MSc RRT

Role: PRINCIPAL_INVESTIGATOR

University of Cincinnati

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Brooks City Base

San Antonio, Texas, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Branson-2010-02

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Nocturnal Oxygen Therapy
NCT00000564 COMPLETED PHASE3