Idiopathic Pulmonary FibrosisIPF/Oxymizer2NCT03411876
Effects of Oxymizer Pendant Cannula Versus Conventional Nasal Cannula During Endurance Shuttle Walk Tests in Hypoxemic Patients With Idiopathic Pulmonary Fibrosis
A study testing Oxymizer® pendant nasal cannula and conventional nasal cannula in people with Idiopathic Pulmonary Fibrosis and Hypoxemia, run by Klaus Kenn at 1 site in Germany.
Trial summary
Aim of this study is to investigate the effects of an Oxymizer pendant nasal cannula in hypoxemic patients with idiopathic pulmonary fibrosis during walking. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Idiopathic Pulmonary Fibrosis, Hypoxemia
- What is being tested?
- Oxymizer® pendant nasal cannula and conventional nasal cannula
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteGermany
- Study dates
- 18 Jan 2018to 15 Jan 2019
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- firmed diagnosis of idiopathic pulmonary fibrosis
- indication for supplemental oxygen therapy during exercise
- referred to an inpatient rehabilitation program at the Schön Klinik Berchtesgadener Land
Who cannot join
- cardiovascular diseases that influence the patient's physical performance
- orthopedic comorbidities that prevent the patient from performing an incremental or endurance shuttle walk test
- carbon dioxide pressure above 45 mmHg at rest and ambient air
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of an Oxymizer Pendant Cannula Versus a Conventional Nasal Cannula During Endurance Shuttle Walk Test (ESWT) in Hypoxemic Patients With Idiopathic Pulmonary Fibrosis
Aim of this study is to investigate the effects of an Oxymizer pendant nasal cannula in hypoxemic patients with idiopathic pulmonary fibrosis during walking.
Read the detailed description
Patients will be recruited during an inpatient pulmonary rehabilitation program. They will perform three shuttle walk tests on three consecutive days (see below). While performing those tests, the patient's prescribed oxygen flow rate is applicated either through the conventional nasal cannula (CNC) or the Oxymizer.On the first day, patients perform an incremental shuttle walk test to determine maximum walking speed using a conventional nasal cannula.
On two consecutive days, patients will perform two endurance shuttle walk tests at 85% of the maximum incremental shuttle walk test speed. Supplemental oxygen will be provided via nasal cannula at the prescribed oxygen flow rate. Patients will be randomly assigned to perform one test with the Oxymizer and the other one with a conventional nasal cannula.
- Conditions
- Idiopathic Pulmonary Fibrosis, Hypoxemia
- Being tested
- Oxymizer® pendant nasal cannula, conventional nasal cannula
- Keywords
- IPF, Oxymizer, oxygen conserving device, pulmonary disease
- Medical subject headings
- Idiopathic Pulmonary Fibrosis, Hypoxia, Lung Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxymizer® pendant nasal cannulaDevice
Supplemental oxygen is provided by an Oxymizer pendant nasal cannula.
conventional nasal cannulaDevice
Supplemental oxygen is provided by a conventional nasal cannula.
| Study group | Role | What they receive |
|---|---|---|
| First ESWT with Oxymizer, second ESWT with CNC | Experimental | Patients in this study arm first perform the first endurance shuttle walk test (ESWT) with the Oxymizer and the second ESWT with a conventional nasal cannula (CNC). Receives: Device: Oxymizer® pendant nasal cannula; Device: conventional nasal cannula |
| First ESWT with CNC, second ESWT with Oxymizer | Experimental | Patients in this study arm first perform the first endurance shuttle walk test (ESWT) with the CNC and the second ESWT with the Oxymizer. Receives: Device: Oxymizer® pendant nasal cannula; Device: conventional nasal cannula |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endurance shuttle walk test distance
Distance patients walk during an endurance shuttle walk test
Measured: at baseline, at isotime of endurance shuttle walk test and at the end (maximum 20 min) of endurance shuttle walk test
Secondary outcomes (5)
oxygen saturation
measured by Sentec Digital Monitoring System
Measured: at baseline, at isotime of endurance shuttle walk test and at the end (maximum 20 min) of endurance shuttle walk test
heart rate
measured by Sentec Digital Monitoring System
Measured: at baseline, at isotime of endurance shuttle walk test and at the end (maximum 20 min) of endurance shuttle walk test
breathing frequency
measured by NoxT3 device
Measured: at baseline, at isotime of endurance shuttle walk test and at the end (maximal 20 min) of endurance shuttle walk test
carbon dioxide pressure
transcutaneously carbon dioxide pressure measured by Sentec Digital Monitoring System
Measured: at baseline, at isotime of endurance shuttle walk test and at the end (maximum 20 min) of endurance shuttle walk test
time to desaturation
time (seconds) is measured until oxygen saturation drops below 90% or 85 % respectively
Measured: From beginning of endurance shuttle walk test until the oxygen saturation reaches defined thresholds, or ESWT reaches maximum time frame of 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2018
- Study start18 Jan 2018
- Primary completion15 Jan 2019
- Study completion15 Jan 2019
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
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Klaus Kenn
- Sponsor type
- University, hospital or other
- Collaborators
- Schön Klinik Berchtesgadener Land
- Responsible party
- Sponsor-investigator, Klaus Kenn, Schön Klinik Berchtesgadener Land
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03411876
- Sponsor's protocol ID
- IPF Oxymizer study II
- Acronym
- IPF/Oxymizer2
- Status last verified
- Apr 2020
- First submitted
- 18 Jan 2018
- Last updated
- 16 Apr 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of an Oxymizer Pendant Cannula Versus a Conventional Nasal Cannula During Endurance Shuttle Walk Test (ESWT) in Hypoxemic Patients With Idiopathic Pulmonary Fibrosis
- ClinicalTrials.gov ID
- NCT03411876
- Acronym / sponsor ID
- IPF/Oxymizer2 / IPF Oxymizer study II
- Conditions
- Idiopathic Pulmonary Fibrosis, Hypoxemia
- Keywords
- IPF, Oxymizer, oxygen conserving device, pulmonary disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Klaus KennUniversity, hospital or other
- Collaborators
- Schön Klinik Berchtesgadener Land
- Study start
- 18 Jan 2018 (actual)
- Primary completion
- 15 Jan 2019 (actual)
- Study completion
- 15 Jan 2019 (actual)
- First posted
- 26 Jan 2018 (actual)
- 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.
Aim of this study is to investigate the effects of an Oxymizer pendant nasal cannula in hypoxemic patients with idiopathic pulmonary fibrosis during walking.
Detailed description
Patients will be recruited during an inpatient pulmonary rehabilitation program. They will perform three shuttle walk tests on three consecutive days (see below). While performing those tests, the patient's prescribed oxygen flow rate is applicated either through the conventional nasal cannula (CNC) or the Oxymizer.On the first day, patients perform an incremental shuttle walk test to determine maximum walking speed using a conventional nasal cannula.
On two consecutive days, patients will perform two endurance shuttle walk tests at 85% of the maximum incremental shuttle walk test speed. Supplemental oxygen will be provided via nasal cannula at the prescribed oxygen flow rate. Patients will be randomly assigned to perform one test with the Oxymizer and the other one with a conventional nasal cannula.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| First ESWT with Oxymizer, second ESWT with CNC | Experimental | Device: Oxymizer® pendant nasal cannula, Device: conventional nasal cannulaPatients in this study arm first perform the first endurance shuttle walk test (ESWT) with the Oxymizer and the second ESWT with a conventional nasal cannula (CNC). |
| First ESWT with CNC, second ESWT with Oxymizer | Experimental | Device: Oxymizer® pendant nasal cannula, Device: conventional nasal cannulaPatients in this study arm first perform the first endurance shuttle walk test (ESWT) with the CNC and the second ESWT with the Oxymizer. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- firmed diagnosis of idiopathic pulmonary fibrosis
- indication for supplemental oxygen therapy during exercise
- referred to an inpatient rehabilitation program at the Schön Klinik Berchtesgadener Land
Key exclusion criteria (3 listed)
- cardiovascular diseases that influence the patient's physical performance
- orthopedic comorbidities that prevent the patient from performing an incremental or endurance shuttle walk test
- carbon dioxide pressure above 45 mmHg at rest and ambient air
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® pendant nasal cannulaSupplemental oxygen is provided by an Oxymizer pendant nasal cannula. | Device | First ESWT with CNC, second ESWT with Oxymizer, First ESWT with Oxymizer, second ESWT with CNC |
| conventional nasal cannulaSupplemental oxygen is provided by a conventional nasal cannula. | Device | First ESWT with CNC, second ESWT with Oxymizer, First ESWT with Oxymizer, second ESWT with CNC |
Primary outcome
Endurance shuttle walk test distance
Time frame: at baseline, at isotime of endurance shuttle walk test and at the end (maximum 20 min) of endurance shuttle walk test
Distance patients walk during an endurance shuttle walk test
5 secondary outcomes
oxygen saturation
Time frame: at baseline, at isotime of endurance shuttle walk test and at the end (maximum 20 min) of endurance shuttle walk test
heart rate
Time frame: at baseline, at isotime of endurance shuttle walk test and at the end (maximum 20 min) of endurance shuttle walk test
breathing frequency
Time frame: at baseline, at isotime of endurance shuttle walk test and at the end (maximal 20 min) of endurance shuttle walk test
carbon dioxide pressure
Time frame: at baseline, at isotime of endurance shuttle walk test and at the end (maximum 20 min) of endurance shuttle walk test
time to desaturation
Time frame: From beginning of endurance shuttle walk test until the oxygen saturation reaches defined thresholds, or ESWT reaches maximum time frame of 20 minutes
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 16 Apr 2020.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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® pendant nasal cannula and conventional nasal cannula in people with Idiopathic Pulmonary Fibrosis and Hypoxemia, run by Klaus Kenn 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 3 inclusion and 3 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 16 Apr 2020. 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?
Endurance shuttle walk test distance (time frame: at baseline, at isotime of endurance shuttle walk test and at the end (maximum 20 min) of endurance shuttle walk test). 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 16 Apr 2020.