Text Size

Effects of an Oxymizer on Endurance Time in Patients With Chronic Lung Diseases

This study is currently recruiting participants.
Verified October 2012 by Klinikum Berchtesgadener Land der Schön-Kliniken
Sponsor:
Information provided by (Responsible Party):
Klaus Kenn, Klinikum Berchtesgadener Land der Schön-Kliniken
ClinicalTrials.gov Identifier:
NCT01713413
First received: February 24, 2012
Last updated: October 22, 2012
Last verified: October 2012
History of Changes
  Purpose

The Oxymizer pendant® is a special oxygen cannula that can be used to supply high flow long term oxygen therapy. It is compatible with a wide variety of oxygen sources. In a reservoir, the Oxymizer® stores pure oxygen so that the concentration of inhaled oxygen is increased.

The aim of this study is to investigate the potential benefit of the Oxymizer® with regard to the blood oxygenation during exercise testing. Given that the "endurance time" is very sensitive for little changes in exercise capacity, this test will be used to show the difference between the Oxymizer® and a conventional nasal cannula regarding exercise duration at 70% of peak Watt and oxygenation.

The tests will be accompanied by blood gas analysis, partial pressure of carbon dioxide and heart rate.


Condition Intervention
COPD
Interstitial Lung Disease
 Device: Oxymizer
Device: conventional nasal cannula

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effects of an Oxymizer Versus Conventional Nasal Cannula on Endurance Time in Patients With Chronic Obstructive Pulmonary Disease IV (COPD) or Interstitial Lung Disease (ILD)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Klinikum Berchtesgadener Land der Schön-Kliniken:

Primary Outcome Measures:
  • Difference between Endurance time with Oxymizer and conventional nasal cannula [ Time Frame: From starting until stopping cycling, up to 60 minutes ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Difference in oxygen saturation with Oxymizer and with conventional nasal cannula [ Time Frame: stopping cycling, up to 60 minutes ] [ Designated as safety issue: No ]
  • Difference in PaCO2 with Oxymizer and with conventional nasal cannula [ Time Frame: Stopping cycling, up to 60 minutes ] [ Designated as safety issue: No ]
    measured by Sentec device


Estimated Enrollment: 75
Study Start Date: February 2012
Estimated Study Completion Date: October 2013
Estimated Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Oxymizer
Using first the Oxymizer and 24 h later the conventional nasal cannula.
 Device: Oxymizer
Using first the Oxymizer and 24 h later the conventional nasal cannula.
Active Comparator: nasal cannula
Using first the conventional nasal cannula and 24 h later the Oxymizer
 Device: conventional nasal cannula
Using first the conventional nasal cannula and 24h later the Oxymizer

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • COPD IV
  • interstitial lung disease
  • long-term oxygen therapy with oxygen flow rate >= 2 L/min

Exclusion Criteria:

  • acute cardial decompensation
  • usual kontraindication for exposure test (higher-grad Hypertension (arterial and pulmonal), cardiac valve vitien, instabile angina pectoris, cardiac arrhythmia)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01713413

Contacts
Contact: Klaus Kenn, Dr. med. 0049865293 ext 1540 kkenn@schoen-kliniken.de
Contact: Bernd Sczepanski, Dr. med. 0049865293 ext 1540 bsczepanski@schoen-kliniken.de

Locations
Germany
Klinikum Berchtesgadener Land Recruiting
Berchtesgaden, Bavaria, Germany, 83714
Contact: Klaus Kenn, Dr. med.     0049865293 ext 1540     kkenn@schoen-kliniken.de    
Sponsors and Collaborators
Klinikum Berchtesgadener Land der Schön-Kliniken
  More Information

No publications provided

Responsible Party: Klaus Kenn, Head physician (department of pneumology), Klinikum Berchtesgadener Land der Schön-Kliniken
ClinicalTrials.gov Identifier: NCT01713413     History of Changes
Other Study ID Numbers: OXYM2012
Study First Received: February 24, 2012
Last Updated: October 22, 2012
Health Authority: Germany: Ethics Commission

Keywords provided by Klinikum Berchtesgadener Land der Schön-Kliniken:
Oxymizer
endurance time
exercise test
nasal cannula
 COPD
ILD
oxygenation

Additional relevant MeSH terms:
Lung Diseases
Pulmonary Disease, Chronic Obstructive
Pulmonary Fibrosis
 Lung Diseases, Interstitial
Lung Diseases, Obstructive
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 19, 2013