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

NCT01713413 | Completed

• 1 other identifier: OXYM2012
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 1

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

Keywords

Oxymizer; endurance time; exercise test; nasal cannula; COPD; ILD; oxygenation

Outcome Measures

Primary Outcomes (1)

• Difference between Endurance time with Oxymizer and conventional nasal cannula

  From starting until stopping cycling, up to 60 minutes

Secondary Outcomes (2)

• 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

Study Arms (2)

Oxymizer

ACTIVE COMPARATOR

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

Device: Oxymizer

nasal cannula

ACTIVE COMPARATOR

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

Device: conventional nasal cannula

Interventions

Oxymizer DEVICE

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

Oxymizer

conventional nasal cannula DEVICE

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

nasal cannula

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• COPD IV
• interstitial lung disease
• long-term oxygen therapy with oxygen flow rate \>= 2 L/min

You may not qualify if:

• acute cardial decompensation
• usual kontraindication for exposure test (higher-grad Hypertension (arterial and pulmonal), cardiac valve vitien, instabile angina pectoris, cardiac arrhythmia)

Sponsors & Collaborators

• Schön Klinik Berchtesgadener Land: lead

Study Sites (1)

Klinikum Berchtesgadener Land

Berchtesgaden, Bavaria, 83714, Germany

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Lung Diseases, Interstitial

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head physician (department of pneumology)

Study Record Dates

• First Submitted: February 24, 2012
• First Posted: October 24, 2012
• Study Start: February 1, 2012
• Primary Completion: February 1, 2014
• Study Completion: March 1, 2014
• Last Updated: April 15, 2014

Record last verified: 2014-04

Locations

DE (1)