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

NCT01294033 | Completed

• 1 other identifier: 2009P000142
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Obstructive Pulmonary Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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.

Study Arms (2)

Fractional inspired oxygen 0.21

PLACEBO COMPARATOR

Cardiopulmonary exercise test performed by subject on Fractional inspired oxygen 0.21

Other: Fractional inspired oxygen (FiO2) 0.21

Fractional inspired oxygen 0.28

ACTIVE COMPARATOR

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

Other: Fractional inspired oxygen 0.28

Interventions

Fractional inspired oxygen (FiO2) 0.21 OTHER

Fractional inspired oxygen 0.21

Fractional inspired oxygen 0.28 OTHER

Supplemental oxygen

Fractional inspired oxygen 0.28

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• David H Roberts, MD

  Beth Israel Deaconess Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Steven P. Simcox, Patrick A. Clifford and James H. Higby Associate Professor of Medicine

Study Record Dates

• First Submitted: February 3, 2011
• First Posted: February 11, 2011
• Study Start: August 1, 2009
• Primary Completion: July 1, 2010
• Study Completion: July 1, 2010
• Last Updated: March 16, 2017

Record last verified: 2017-03

Locations

US (1)