Text Size

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

This study has been completed.
Sponsor:
Information provided by:
Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier:
NCT01294033
First received: February 3, 2011
Last updated: February 10, 2011
Last verified: February 2011
History of Changes
  Purpose

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.


Condition Intervention
Chronic Obstructive Pulmonary Disease
 Other: Fractional inspired oxygen (FiO2) 0.21
Other: Fractional inspired oxygen 0.28

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Official Title: Effect of Therapeutic Hyperoxia on Maximal Oxygen Consumption and Perioperative Risk Stratification in Patients With Chronic Obstructive Pulmonary Disease

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Beth Israel Deaconess Medical Center:

Primary Outcome Measures:
  • Maximal oxygen consumption [ Time Frame: 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. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Minute ventilation - Carbon dioxide production slope [ Time Frame: 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. ] [ Designated as safety issue: No ]
  • Exercise time [ Time Frame: 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. ] [ Designated as safety issue: No ]
  • Oxygen saturation [ Time Frame: 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. ] [ Designated as safety issue: No ]
  • Maximum watts achieved [ Time Frame: 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. ] [ Designated as safety issue: No ]
  • Maximum minute ventilation [ Time Frame: 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. ] [ Designated as safety issue: No ]

Enrollment: 20
Study Start Date: August 2009
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01294033

Locations
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
Investigators
Principal Investigator: David H Roberts, MD Beth Israel Deaconess Medical Center
  More Information

No publications provided

Responsible Party: David H. Roberts, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT01294033     History of Changes
Other Study ID Numbers: 2009-P-000142/01
Study First Received: February 3, 2011
Last Updated: February 10, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 16, 2013