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

Effect of Therapeutic Hyperoxia on Maximal Oxygen Consumption and Perioperative Risk Stratification in Patients With Chronic Obstructive Pulmonary Disease

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.

Study Overview

• Status: Completed
• Conditions: Chronic Obstructive Pulmonary Disease
• Intervention / Treatment: Other: Fractional inspired oxygen (FiO2) 0.21; Other: Fractional inspired oxygen 0.28

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Beth Israel Deaconess Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Fractional inspired oxygen 0.21; Cardiopulmonary exercise test performed by subject on Fractional inspired oxygen 0.21	Other: Fractional inspired oxygen (FiO2) 0.21
Active Comparator: Fractional inspired oxygen 0.28; Cardiopulmonary exercise test performed on supplemental oxygen (Fractional inspired oxygen 0.28)	Other: Fractional inspired oxygen 0.28; Supplemental oxygen

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome Measure	Time Frame
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.
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.
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.

Collaborators and Investigators

• Sponsor: Beth Israel Deaconess Medical Center
• Investigators: Principal Investigator: David H Roberts, MD, Beth Israel Deaconess Medical Center

Study record dates

Study Major Dates

• Study Start: August 1, 2009
• Primary Completion (Actual): July 1, 2010
• Study Completion (Actual): July 1, 2010

Study Registration Dates

• First Submitted: February 3, 2011
• First Submitted That Met QC Criteria: February 10, 2011
• First Posted (Estimate): February 11, 2011

Study Record Updates

• Last Update Posted (Actual): March 16, 2017
• Last Update Submitted That Met QC Criteria: March 15, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: 2009P000142