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

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01294033
• Other study ID #: 2009P000142
• Status: Completed
• Phase: N/A
• First received: February 3, 2011
• Last updated: March 15, 2017
• Start date: August 2009
• Est. completion date: July 2010

Study information

• Verified date: March 2017
• Source: Beth Israel Deaconess Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: July 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Other:
• Fractional inspired oxygen (FiO2) 0.21

• Fractional inspired oxygen 0.28
Supplemental oxygen

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Beth Israel Deaconess Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.