Idiopathic Pulmonary FibrosisNCT02268981
Effects of an Oxymizer® During Daytime in Patients With Pulmonary Fibrosis (IPF)
A study testing Oxymizer® compared to CNC in people with Idiopathic Pulmonary Fibrosis, run by Schön Klinik Berchtesgadener Land at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Idiopathic Pulmonary Fibrosis
- What is being tested?
- Oxymizer® compared to CNC
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2014to Sep 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- IPF patients with indication for long term oxygen therapy ≥ 2l/min
- VC >30% and < 70% pred.
Who cannot join
- failure to comply with study process
- acute infection
Trial locations and contacts
1 site in 1 country.
Germany1 site
Klinikum Berchtesgadener Land der Schön-Kliniken
Schönau am Königssee, Bavaria, 83471
About this study
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.
Read the 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.
- Conditions
- Idiopathic Pulmonary Fibrosis
- Being tested
- Oxymizer® compared to CNC
- Keywords
- Oxymizer, Oxygen conserving device, Conventional nasal cannula (CNC), Idiopathic pulmonary fibrosis
- Medical subject headings
- Idiopathic Pulmonary Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxymizer® compared to CNCDevice
Also called Conventional Nasal Cannula (CNC)
Oxygen Saturation measurement for 12 h with CNC
Oxymizer® compared to CNCDevice
Also called Oxymizer
Oxygen Saturation measurement for 12 h with Oxymizer®
Oxymizer® compared to CNCDevice
Also called Oxymizer with reduced flow rate (-1l/min)
Saturation measurement for 12 h with Oxymizer® by reduced flow rate (-1l/min)
| Study group | Role | What they receive |
|---|---|---|
| Oxymizer® compared to CNC | Experimental | 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. Receives: Device: Oxymizer® compared to CNC |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: day 1 to 13
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2014 (estimated)
- Study startSep 2014
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Pulmonary FibrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Schön Klinik Berchtesgadener Land
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Klaus Kenn, Schön Klinik Berchtesgadener Land
- Investigators
- Klaus Kenn, Dr. med, Study chair, Schoen Klinik BGL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02268981
- Sponsor's protocol ID
- 12hOXY-ILD2014
- Status last verified
- Sep 2015
- First submitted
- 17 Sep 2014
- Last updated
- 3 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of an Oxymizer® During Daytime in Patients With Pulmonary Fibrosis (IPF)
- ClinicalTrials.gov ID
- NCT02268981
- Acronym / sponsor ID
- 12hOXY-ILD2014
- Conditions
- Idiopathic Pulmonary Fibrosis
- Keywords
- Oxymizer, Oxygen conserving device, Conventional nasal cannula (CNC), Idiopathic pulmonary fibrosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Schön Klinik Berchtesgadener LandUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 20 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Oxymizer® compared to CNC | Experimental | Device: Oxymizer® compared to CNCFrom 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. |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- IPF patients with indication for long term oxygen therapy ≥ 2l/min
- VC >30% and < 70% pred.
Key exclusion criteria (2 listed)
- failure to comply with study process
- acute infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oxymizer® compared to CNCAlso: Conventional Nasal Cannula (CNC)Oxygen Saturation measurement for 12 h with CNC | Device | Oxymizer® compared to CNC |
| Oxymizer® compared to CNCAlso: OxymizerOxygen Saturation measurement for 12 h with Oxymizer® | Device | Oxymizer® compared to CNC |
| Oxymizer® compared to CNCAlso: Oxymizer with reduced flow rate (-1l/min)Saturation measurement for 12 h with Oxymizer® by reduced flow rate (-1l/min) | Device | Oxymizer® compared to CNC |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Klaus Kenn, Dr. med study chair
Schoen Klinik BGL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oxymizer® compared to CNC in people with Idiopathic Pulmonary Fibrosis, run by Schön Klinik Berchtesgadener Land at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in oxygen saturation between Oxymizer and conventional nasal cannula (time frame: day 1 to 13). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2015.