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

Sponsor
Schön Klinik Berchtesgadener Land (Other)
Overall Status
Completed
CT.gov ID
NCT02268981
Collaborator
(none)
18
Enrollment
1
Location
1
Arm
12
Duration (Months)
1.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Oxymizer® compared to CNC
  • Device: Oxymizer® compared to CNC
  • Device: Oxymizer® compared to CNC
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
18 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Effects of an Oxymizer® During Daytime in Patients With Pulmonary Fibrosis (IPF)
Study Start Date :
Sep 1, 2014
Actual Primary Completion Date :
Sep 1, 2015
Actual Study Completion Date :
Sep 1, 2015

Arms and Interventions

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)

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Difference in oxygen saturation between Oxymizer and conventional nasal cannula [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    30 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Klinikum Berchtesgadener Land der Schön-Kliniken Schoenau am Koenigssee Bayern Germany 83471

    Sponsors and Collaborators

    • Schön Klinik Berchtesgadener Land

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Klaus Kenn, Dr. med., Schön Klinik Berchtesgadener Land
    ClinicalTrials.gov Identifier:
    NCT02268981
    Other Study ID Numbers:
    • 12hOXY-ILD2014
    First Posted:
    Oct 20, 2014
    Last Update Posted:
    Sep 3, 2015
    Last Verified:
    Sep 1, 2015
    Keywords provided by Klaus Kenn, Dr. med., Schön Klinik Berchtesgadener Land
    Oxymizer
    Oxygen conserving device
    Conventional nasal cannula (CNC)
    Idiopathic pulmonary fibrosis
    Additional relevant MeSH terms:
    Pulmonary Fibrosis
    Idiopathic Pulmonary Fibrosis
    Fibrosis

    Study Results

    No Results Posted as of Sep 3, 2015