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

NCT ID: NCT01713413

Last Updated: 2014-04-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 67 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-02-29
• Study Completion Date: 2014-03-31

Brief Summary

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.

Conditions

COPD; Interstitial Lung Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Oxymizer

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

Group Type: ACTIVE_COMPARATOR

Oxymizer

Intervention Type: DEVICE

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

nasal cannula

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

Group Type: ACTIVE_COMPARATOR

conventional nasal cannula

Intervention Type: DEVICE

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

Interventions

Oxymizer

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

Intervention Type: DEVICE

conventional nasal cannula

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

Intervention Type: DEVICE

Eligibility 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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Schön Klinik Berchtesgadener Land

OTHER

Sponsor Role: lead

Responsible Party

Klaus Kenn

Head physician (department of pneumology)

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Klinikum Berchtesgadener Land

Berchtesgaden, Bavaria, Germany

Countries

Germany

Other Identifiers

OXYM2012

Identifier Type: -

Identifier Source: org_study_id