Effects of an Oxymizer® During Daytime in Patients With Pulmonary Fibrosis (IPF)
Primary Purpose
Idiopathic Pulmonary Fibrosis
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Oxymizer® compared to CNC
Oxymizer® compared to CNC
Oxymizer® compared to CNC
Sponsored by
About this trial
This is an interventional treatment trial for Idiopathic Pulmonary Fibrosis focused on measuring Oxymizer, Oxygen conserving device, Conventional nasal cannula (CNC), Idiopathic pulmonary fibrosis
Eligibility Criteria
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
Sites / Locations
- Klinikum Berchtesgadener Land der Schön-Kliniken
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Oxymizer® compared to CNC
Arm Description
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.
Outcomes
Primary Outcome Measures
Difference in oxygen saturation between Oxymizer and conventional nasal cannula
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT02268981
First Posted
September 17, 2014
Last Updated
September 2, 2015
Sponsor
Schön Klinik Berchtesgadener Land
1. Study Identification
Unique Protocol Identification Number
NCT02268981
Brief Title
Effects of an Oxymizer® During Daytime in Patients With Pulmonary Fibrosis (IPF)
Official Title
Effects of an Oxymizer® During Daytime in Patients With Pulmonary Fibrosis (IPF)
Study Type
Interventional
2. Study Status
Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
September 2014 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
September 2015 (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
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Idiopathic Pulmonary Fibrosis
Keywords
Oxymizer, Oxygen conserving device, Conventional nasal cannula (CNC), Idiopathic pulmonary fibrosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Oxymizer® compared to CNC
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Oxymizer® compared to CNC
Other Intervention Name(s)
Conventional Nasal Cannula (CNC)
Intervention Description
Oxygen Saturation measurement for 12 h with CNC
Intervention Type
Device
Intervention Name(s)
Oxymizer® compared to CNC
Other Intervention Name(s)
Oxymizer
Intervention Description
Oxygen Saturation measurement for 12 h with Oxymizer®
Intervention Type
Device
Intervention Name(s)
Oxymizer® compared to CNC
Other Intervention Name(s)
Oxymizer with reduced flow rate (-1l/min)
Intervention Description
Saturation measurement for 12 h with Oxymizer® by reduced flow rate (-1l/min)
Primary Outcome Measure Information:
Title
Difference in oxygen saturation between Oxymizer and conventional nasal cannula
Description
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.
Time Frame
day 1 to 13
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Klaus Kenn, Dr. med
Organizational Affiliation
Schoen Klinik BGL
Official's Role
Study Chair
Facility Information:
Facility Name
Klinikum Berchtesgadener Land der Schön-Kliniken
City
Schoenau am Koenigssee
State/Province
Bayern
ZIP/Postal Code
83471
Country
Germany
12. IPD Sharing Statement
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Effects of an Oxymizer® During Daytime in Patients With Pulmonary Fibrosis (IPF)
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