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

Beth Israel Lahey Health

Status: Completed

Conditions: Chronic Obstructive Pulmonary Disease

Treatments: Other: Fractional inspired oxygen 0.28; Other: Fractional inspired oxygen (FiO2) 0.21

Study type: Interventional

Funder types: Other

Identifiers

NCT01294033

2009P000142

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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20 participants in 2 patient groups, including a placebo group

Fractional inspired oxygen 0.21

Placebo Comparator group

Description:

Cardiopulmonary exercise test performed by subject on Fractional inspired oxygen 0.21

Treatment:

Other: Fractional inspired oxygen (FiO2) 0.21

Fractional inspired oxygen 0.28

Active Comparator group

Description:

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

Treatment:

Other: Fractional inspired oxygen 0.28