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Helium-Hyperoxia and 6MWT Distance in COPD

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00394225
First Posted: October 31, 2006
Last Update Posted: October 31, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Nova Scotia Health Authority
Information provided by:
University of Saskatchewan
  Purpose
We assessed the effect of altering inspired gas on the 6MWT distance in COPD. We hypothesized that HeO2 would improve walking distance and reduce shortness of breath compared to both RA and O2, and potentially improve quality of life for COPD patients.

Condition Intervention
Chronic Obstructive Pulmonary Disease Drug: Oxygen Drug: Helium

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single
Primary Purpose: Treatment
Official Title: The Effects of Helium-Hyperoxia on 6-Minute Walking Distance in Chronic Obstructive Pulmonary Disease – A Randomized, Controlled Trial

Resource links provided by NLM:


Further study details as provided by University of Saskatchewan:

Primary Outcome Measures:
  • 6 minute walking distance

Secondary Outcome Measures:
  • shortness of breath
  • leg fatigue
  • arterial oxygen saturation

Estimated Enrollment: 16
Study Start Date: July 2005
Estimated Study Completion Date: May 2006
Detailed Description:

We hypothesized that inspiring helium-hyperoxia (HeO2) would significantly improve 6-minute walking test (6MWT) distance in Chronic Obstructive Pulmonary Disease (COPD) subjects.

This was a blinded, randomized crossover study. At Visit 1 we assessed pulmonary function, exercise capacity and 6MWT distance. Visits 2 and 3 consisted of four 6MWT with different inspired gases: room air by mask (RA), 100% O2 by mask (Mask O2), 100% O2 by nasal prongs (Nasal O2), and 70% He/30% O2 by mask (HeO2). Walking distance, shortness of breath, leg fatigue, O2 saturation and heart rate (HR) were assessed

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Exertional dyspnea
  • Activity limitation
  • COPD

Exclusion Criteria:

  • Recent exacerbation (< 4 wks)
  • Supplemental O2
  • Significant cardiovascular/musculoskeletal abnormalities
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00394225


Locations
Canada, Alberta
Edmonton General Hospital, Caritas Lung HEalth Centre
Edmonton, Alberta, Canada
Sponsors and Collaborators
University of Saskatchewan
Nova Scotia Health Authority
Investigators
Principal Investigator: Darcy D Marciniuk, MD, FRCP(C) University of Saskatchewan
  More Information

ClinicalTrials.gov Identifier: NCT00394225     History of Changes
Other Study ID Numbers: BIO-REB 05-186
First Submitted: October 30, 2006
First Posted: October 31, 2006
Last Update Posted: October 31, 2006
Last Verified: October 2006

Keywords provided by University of Saskatchewan:
6-Minute Walk Test
COPD
Helium-Hyperoxia
Exercise
Chronic Obstructive Pulmonary Disease (COPD)

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Hyperoxia
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms