Effects of an Oxymizer® During Daytime in Patients With Pulmonary Fibrosis (IPF)

September 2, 2015 updated by: Klaus Kenn, Schön Klinik Berchtesgadener Land
This study will investigate the effects of a reservoir nasal cannula (Oxymizer®) compared to a conventional nasal cannula (CNC) in patients with idiopathic pulmonary fibrosis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Patients will be recruited during a 3-week inpatient pulmonary rehabilitation program. They will perform the following three interventions on consecutive days and will repeat them after a week. During these days the time table for prescribed physical activities and therapies will be kept in a comparable fashion.

The following 3 interventions will be performed in randomized order:

Day A: The Patient wears a conventional nasal cannula for 12 h with oxygen flow rate as prescribed during ADL

Day B: The Patient wears the Oxymizer® with prescribed oxygen flow rate for 12 h during ADL

Day C: The patient wears the Oxymizer® with a flow rate reduced by 1l/min in comparison to the prescribed oxygen flow rate, for 12h

The following week the same measurements will be repeated. The mean of the corresponding two measures will be calculated for each approach.

Study Type

Interventional

Enrollment (Actual)

18

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
    • Bayern
      • Schoenau am Koenigssee, Bayern, Germany, 83471
        • Klinikum Berchtesgadener Land der Schön-Kliniken

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

30 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • IPF patients with indication for long term oxygen therapy ≥ 2l/min
  • VC >30% and < 70% pred.

Exclusion Criteria:

  • failure to comply with study process
  • acute infection

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: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Oxymizer® compared to CNC

From 7am to 7pm oxygen saturation is measured by a pulse oximeter. One day with conventional nasal cannula, one day with Oxymizer®, one day with Oxymizer® and reduced Oxygen flow (-1l/min). The order of these days is randomized in 6 groups.

The intervention will be performed on consecutive days and twice during study period.
Device: Oxymizer® compared to CNC
Oxygen Saturation measurement for 12 h with CNC
Other Names:
  • Conventional Nasal Cannula (CNC)
Device: Oxymizer® compared to CNC
Oxygen Saturation measurement for 12 h with Oxymizer®
Other Names:
  • Oxymizer
Device: Oxymizer® compared to CNC
Saturation measurement for 12 h with Oxymizer® by reduced flow rate (-1l/min)
Other Names:
  • Oxymizer with reduced flow rate (-1l/min)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference in oxygen saturation between Oxymizer and conventional nasal cannula
Time Frame: day 1 to 13
Oxygen Saturation will be measured via pulseoxymetry for 12 hours. On 2 days, mean oxygen Saturation will be reported while using Oxymizer or a conventional nasal cannula, both with similar Oxygen flow. The difference of the mean Oxygen Saturation of 12 hours between both cannulae will be the Primary outcome.
day 1 to 13

Collaborators and Investigators

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

Sponsor

Schön Klinik Berchtesgadener Land

Investigators

  • Study Chair: Klaus Kenn, Dr. med, Schoen Klinik BGL

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

September 1, 2014

Primary Completion (ACTUAL)

September 1, 2015

Study Completion (ACTUAL)

September 1, 2015

Study Registration Dates

First Submitted

September 17, 2014

First Submitted That Met QC Criteria

October 16, 2014

First Posted (ESTIMATE)

October 20, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

September 3, 2015

Last Update Submitted That Met QC Criteria

September 2, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12hOXY-ILD2014

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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