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

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Fractional inspired oxygen (FiO2) 0.21
Fractional inspired oxygen 0.28
Sponsored by
Beth Israel Deaconess Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Chronic Obstructive Pulmonary Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Beth Israel Deaconess Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Fractional inspired oxygen 0.21

Fractional inspired oxygen 0.28

Arm Description

Cardiopulmonary exercise test performed by subject on Fractional inspired oxygen 0.21

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

Outcomes

Primary Outcome Measures

Maximal oxygen consumption

Secondary Outcome Measures

Minute ventilation - Carbon dioxide production slope
Exercise time
Oxygen saturation
Maximum watts achieved
Maximum minute ventilation

Full Information

First Posted
February 3, 2011
Last Updated
March 15, 2017
Sponsor
Beth Israel Deaconess Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01294033
Brief Title
Effect of Supplemental Oxygen on Maximal Oxygen Consumption in Patients With Chronic Obstructive Pulmonary Disease
Official Title
Effect of Therapeutic Hyperoxia on Maximal Oxygen Consumption and Perioperative Risk Stratification in Patients With Chronic Obstructive Pulmonary Disease
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
August 2009 (undefined)
Primary Completion Date
July 2010 (Actual)
Study Completion Date
July 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beth Israel Deaconess Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Fractional inspired oxygen 0.21
Arm Type
Placebo Comparator
Arm Description
Cardiopulmonary exercise test performed by subject on Fractional inspired oxygen 0.21
Arm Title
Fractional inspired oxygen 0.28
Arm Type
Active Comparator
Arm Description
Cardiopulmonary exercise test performed on supplemental oxygen (Fractional inspired oxygen 0.28)
Intervention Type
Other
Intervention Name(s)
Fractional inspired oxygen (FiO2) 0.21
Intervention Type
Other
Intervention Name(s)
Fractional inspired oxygen 0.28
Intervention Description
Supplemental oxygen
Primary Outcome Measure Information:
Title
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.
Secondary Outcome Measure Information:
Title
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.
Title
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.
Title
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.
Title
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.
Title
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David H Roberts, MD
Organizational Affiliation
Beth Israel Deaconess Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States

12. IPD Sharing Statement

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

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