Effects of an Oxymizer on Endurance Time in Patients With... | NCT01713413

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

NCT01713413

Sponsor

Schön Klinik Berchtesgadener Land

Status

Completed

Last Update Posted

Apr 15, 2014Estimated

Enrollment

67Actual

Phase

Not Applicable

Conditions

COPD
Interstitial Lung Disease

Interventions

Oxymizer
conventional nasal cannula

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2012

Primary Completion Date

Feb 2014Actual

Completion Date

Mar 2014Actual

First Submitted Date

Feb 24, 2012

First Submission Date that Met QC Criteria

Oct 22, 2012

First Posted Date

Oct 24, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 14, 2014

Last Update Posted Date

Apr 15, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Klaus Kenn, Head physician (department of pneumology), Schön Klinik Berchtesgadener LandPrincipal Investigator

Lead Sponsor

Schön Klinik Berchtesgadener LandOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

67Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Oxymizer	Device	Using first the Oxymizer and 24 h later the conventional nasal cannula.	Oxymizer

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
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	measured by Sentec device

Other Outcomes

Not provided

Eligibility Module

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)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Klinikum Berchtesgadener Land		Berchtesgaden	Bavaria	83714	Germany

Condition Browse Module

MeSH Terms

ID	Term
D029424	Pulmonary Disease, Chronic Obstructive
D017563	Lung Diseases, Interstitial

Ancestor Terms

ID	Term
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D002908	Chronic Disease

Browse Leaves

Not provided

Browse Branches

Not provided