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

Primary Purpose

COPD, Interstitial Lung Disease

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Oxymizer
conventional nasal cannula
Sponsored by
Schön Klinik Berchtesgadener Land
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COPD focused on measuring Oxymizer, endurance time, exercise test, nasal cannula, COPD, ILD, oxygenation

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Klinikum Berchtesgadener Land

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Oxymizer

nasal cannula

Arm Description

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

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

Outcomes

Primary Outcome Measures

Difference between Endurance time with Oxymizer and conventional nasal cannula

Secondary Outcome Measures

Difference in oxygen saturation with Oxymizer and with conventional nasal cannula
Difference in PaCO2 with Oxymizer and with conventional nasal cannula
measured by Sentec device

Full Information

First Posted
February 24, 2012
Last Updated
April 14, 2014
Sponsor
Schön Klinik Berchtesgadener Land
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1. Study Identification

Unique Protocol Identification Number
NCT01713413
Brief Title
Effects of an Oxymizer on Endurance Time in Patients With Chronic Lung Diseases
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)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
February 2012 (undefined)
Primary Completion Date
February 2014 (Actual)
Study Completion Date
March 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Schön Klinik Berchtesgadener Land

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COPD, Interstitial Lung Disease
Keywords
Oxymizer, endurance time, exercise test, nasal cannula, COPD, ILD, oxygenation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
67 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Oxymizer
Arm Type
Active Comparator
Arm Description
Using first the Oxymizer and 24 h later the conventional nasal cannula.
Arm Title
nasal cannula
Arm Type
Active Comparator
Arm Description
Using first the conventional nasal cannula and 24 h later the Oxymizer
Intervention Type
Device
Intervention Name(s)
Oxymizer
Intervention Description
Using first the Oxymizer and 24 h later the conventional nasal cannula.
Intervention Type
Device
Intervention Name(s)
conventional nasal cannula
Intervention Description
Using first the conventional nasal cannula and 24h later the Oxymizer
Primary Outcome Measure Information:
Title
Difference between Endurance time with Oxymizer and conventional nasal cannula
Time Frame
From starting until stopping cycling, up to 60 minutes
Secondary Outcome Measure Information:
Title
Difference in oxygen saturation with Oxymizer and with conventional nasal cannula
Time Frame
stopping cycling, up to 60 minutes
Title
Difference in PaCO2 with Oxymizer and with conventional nasal cannula
Description
measured by Sentec device
Time Frame
Stopping cycling, up to 60 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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)
Facility Information:
Facility Name
Klinikum Berchtesgadener Land
City
Berchtesgaden
State/Province
Bavaria
ZIP/Postal Code
83714
Country
Germany

12. IPD Sharing Statement

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

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