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

February 3, 2011
February 10, 2011
August 2009
July 2010   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01294033 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Chronic Obstructive Pulmonary Disease
  • Other: Fractional inspired oxygen (FiO2) 0.21
  • Other: Fractional inspired oxygen 0.28
    Supplemental oxygen
  • Placebo Comparator: Fractional inspired oxygen 0.21
    Cardiopulmonary exercise test performed by subject on Fractional inspired oxygen 0.21
    Intervention: 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)
    Intervention: Other: Fractional inspired oxygen 0.28
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
July 2010
July 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01294033
2009-P-000142/01
No
David H. Roberts, Beth Israel Deaconess Medical Center
Beth Israel Deaconess Medical Center
Not Provided
Principal Investigator: David H Roberts, MD Beth Israel Deaconess Medical Center
Beth Israel Deaconess Medical Center
February 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP