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

April 14, 2014 updated by: Klaus Kenn, Schön Klinik Berchtesgadener Land

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)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

67

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Bavaria
      • Berchtesgaden, Bavaria, Germany, 83714
        • Klinikum Berchtesgadener Land

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Difference between Endurance time with Oxymizer and conventional nasal cannula
Time Frame: From starting until stopping cycling, up to 60 minutes
From starting until stopping cycling, up to 60 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference in oxygen saturation with Oxymizer and with conventional nasal cannula
Time Frame: stopping cycling, up to 60 minutes
stopping cycling, up to 60 minutes
Difference in PaCO2 with Oxymizer and with conventional nasal cannula
Time Frame: Stopping cycling, up to 60 minutes
measured by Sentec device
Stopping cycling, up to 60 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Schön Klinik Berchtesgadener Land

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2012

Primary Completion (ACTUAL)

February 1, 2014

Study Completion (ACTUAL)

March 1, 2014

Study Registration Dates

First Submitted

February 24, 2012

First Submitted That Met QC Criteria

October 22, 2012

First Posted (ESTIMATE)

October 24, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

April 15, 2014

Last Update Submitted That Met QC Criteria

April 14, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OXYM2012

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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