Effect of Supplemental Oxygen on Maximal Oxygen Consumption in Patients With Chronic Obstructive Pulmonary Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-08-31

Study Completion Date

2010-07-31

Brief Summary

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Maximal consumption of oxygen (VO2max) during exercise is used in patients with chronic obstructive pulmonary disease (COPD) to stratify perioperative risk. However, the impact of supplemental oxygen to prevent hypoxemia during exercise on maximal oxygen consumption and other ventilatory parameters during maximal exercise in the resting normoxic Chronic Obstructive Pulmonary Disease population is poorly defined. The investigators performed a randomized controlled trial in patients with COPD who underwent cardiopulmonary exercise tests on room air and supplemental oxygen. The investigators compared maximal oxygen consumption and other ventilatory parameters in each individual subject under the two conditions.

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Detailed Description

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Conditions

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Chronic Obstructive Pulmonary Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Fractional inspired oxygen 0.21

Cardiopulmonary exercise test performed by subject on Fractional inspired oxygen 0.21

Group Type PLACEBO_COMPARATOR

Fractional inspired oxygen (FiO2) 0.21

Intervention Type OTHER

Fractional inspired oxygen 0.28

Cardiopulmonary exercise test performed on supplemental oxygen (Fractional inspired oxygen 0.28)

Group Type ACTIVE_COMPARATOR

Fractional inspired oxygen 0.28

Intervention Type OTHER

Supplemental oxygen

Interventions

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Fractional inspired oxygen (FiO2) 0.21

Intervention Type OTHER

Fractional inspired oxygen 0.28

Supplemental oxygen

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Clinical diagnosis of Chronic Obstructive Pulmonary Disease (COPD).
* Pulmonary function characterized by forced expiratory volume in 1 second/forced vital capacity ratio\<0.7, and forced expiratory volume in one second \<80% predicted.

Exclusion Criteria

* Subjects with a recent COPD exacerbation requiring emergency department visit or hospitalization within the last month.
* Subjects scheduled for a major pulmonary intervention in the next 3 months
* Subjects with severe peripheral vascular disease or other physical conditions that would preclude exercise testing

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes