Chronic Obstructive Pulmonary Disease
Conditions
Brief summary
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.
Interventions
OTHERFractional inspired oxygen (FiO2) 0.21
OTHERFractional inspired oxygen 0.28
Supplemental oxygen
Sponsors
Beth Israel Deaconess Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximal oxygen consumption | Outcomes are measured at time of study visit when patient reaches maximal exercise during cardiopulmonary exercise test. Measurements occur at time of test within 30 minutes of exercise. This is not a longitudinal study measuring outcomes over time. |
Secondary
| Measure | Time frame |
|---|---|
| Exercise time | Outcomes are measured at time of study visit when patient reaches maximal exercise during cardiopulmonary exercise test. Measurements occur at time of test within 30 minutes of exercise. This is not a longitudinal study measuring outcomes over time. |
| Oxygen saturation | Outcomes are measured at time of study visit when patient reaches maximal exercise during cardiopulmonary exercise test. Measurements occur at time of test within 30 minutes of exercise. This is not a longitudinal study measuring outcomes over time. |
| Maximum watts achieved | Outcomes are measured at time of study visit when patient reaches maximal exercise during cardiopulmonary exercise test. Measurements occur at time of test within 30 minutes of exercise. This is not a longitudinal study measuring outcomes over time. |
| Minute ventilation - Carbon dioxide production slope | Outcomes are measured at time of study visit when patient reaches maximal exercise during cardiopulmonary exercise test. Measurements occur at time of test within 30 minutes of exercise. This is not a longitudinal study measuring outcomes over time. |
| Maximum minute ventilation | Outcomes are measured at time of study visit when patient reaches maximal exercise during cardiopulmonary exercise test. Measurements occur at time of test within 30 minutes of exercise. This is not a longitudinal study measuring outcomes over time. |
Countries
United States
Outcome results
None listed