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

COPD Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01713413
• Other study ID #: OXYM2012
• Status: Completed
• Phase: N/A
• First received: February 24, 2012
• Last updated: April 14, 2014
• Start date: February 2012
• Est. completion date: March 2014

Study information

• Verified date: April 2014
• Source: Klinikum Berchtesgadener Land der Schön-Kliniken
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: March 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• COPD
• Interstitial Lung Disease
• Lung Diseases
• Lung Diseases, Interstitial

Intervention

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

Locations

Country	Name	City	State
Germany	Klinikum Berchtesgadener Land	Berchtesgaden	Bavaria

Sponsors (1)

Lead Sponsor	Collaborator
Klinikum Berchtesgadener Land der Schön-Kliniken

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference between Endurance time with Oxymizer and conventional nasal cannula		From starting until stopping cycling, up to 60 minutes	Yes
Secondary	Difference in oxygen saturation with Oxymizer and with conventional nasal cannula		stopping cycling, up to 60 minutes	No
Secondary	Difference in PaCO2 with Oxymizer and with conventional nasal cannula	measured by Sentec device	Stopping cycling, up to 60 minutes	No