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OpenTrials
Completed

NCT Number: NCT01713413

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

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.

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Key information

Conditions

COPD Chronic Disease Disease Attributes Interstitial Lung Disease Lung Diseases Lung Diseases, Interstitial Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Klinikum Berchtesgadener Land

Berchtesgaden, Bavaria, 83714, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Oxymizer

Device

Using first the Oxymizer and 24 h later the conventional nasal cannula.

conventional nasal cannula

Device

Using first the conventional nasal cannula and 24h later the Oxymizer

Primary outcomes

  1. Difference between Endurance time with Oxymizer and conventional nasal cannula

    Time frame: From starting until stopping cycling, up to 60 minutes

Secondary outcomes

  1. Difference in oxygen saturation with Oxymizer and with conventional nasal cannula

    Time frame: stopping cycling, up to 60 minutes

  2. Difference in PaCO2 with Oxymizer and with conventional nasal cannula

    Time frame: Stopping cycling, up to 60 minutes

    measured by Sentec device

Sponsors and collaborators

Lead sponsor

Schön Klinik Berchtesgadener Land

Other

Registry information

Official study 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)

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Oct 24, 2012
Registry last updated
Apr 15, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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