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

Not Applicable

Completed

• Conditions: COPD; Interstitial Lung Disease
• Interventions: Device: Oxymizer; Device: conventional nasal cannula

• Registration Number: NCT01713413
• Lead Sponsor: Schön Klinik Berchtesgadener Land

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-02
• Study First Submitted: 2012-02-24
• Study First Submitted QC: 2012-10-22
• Study First Posted: 2012-10-24
• Primary Completion: 2014-02
• Study Completion: 2014-03
• Status Verified: 2014-04
• Last Update Submitted: 2014-04-14
• Last Update Posted: 2014-04-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 67

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Difference between Endurance time with Oxymizer and conventional nasal cannula	From starting until stopping cycling, up to 60 minutes

Secondary Outcome Measures

Name	Time	Method
Difference in oxygen saturation with Oxymizer and with conventional nasal cannula	stopping cycling, up to 60 minutes
Difference in PaCO2 with Oxymizer and with conventional nasal cannula	Stopping cycling, up to 60 minutes	measured by Sentec device

Trial Locations

Locations (1)

Klinikum Berchtesgadener Land; 🇩🇪 Berchtesgaden, Bavaria, Germany