Chronic Obstructive Pulmonary DiseaseNCT02744170
Effects of Supplemental Oxygen Delivery Via Demand Versus Continuous Flow in Hypoxemic COPD Patients
A study testing 1 continuous flow oxygen supplementation, 2 demand delivery liquid oxygen supplementation and 3 demand delivery oxygen supplementation via concentrator in people with Chronic Obstructive Pulmonary Disease, run by Schön Klinik Berchtesgadener Land at 1 site in Germany.
Trial summary
Oxygen supplementation has been proven to be effective in hypoxemic COPD patients by increasing oxygenation and reducing dyspnea. In clinical practice there are three common oxygen delivery systems used: continuous oxygen flow (CF), demand oxygen delivery with liquid oxygen (DDL) and demand oxgen delivery with… Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- 1 continuous flow oxygen supplementation, 2 demand delivery liquid oxygen supplementation and 3 demand delivery oxygen supplementation via concentrator
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2016to Oct 2018
- 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 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- COPD patients (GOLD stage III to IV) with hypoxemia at rest or during exercise (paO2<60mmHg)
- Participation in an inpatient pulmonary rehabilitation program (Schön Klinik BGL)
- Written informed consent
Who cannot join
- General exclusion criteria for exercise tests, e.g. acute coronary syndrome, acute myo- or pericarditis, acute lung embolism, pulmonary infarction, acute uncontrolled heart insufficiency
- Signs of acute exacerbation
- Any orthopedic or neurological disabilities that prevent patient from walking
Trial locations and contacts
1 site in 1 country.
Germany1 site
Klinikum Berchtesgadener Land
Schönau, Berchtesgardener Land, 83471
About this study
Oxygen supplementation has been proven to be effective in hypoxemic COPD patients by increasing oxygenation and reducing dyspnea. In clinical practice there are three common oxygen delivery systems used: continuous oxygen flow (CF), demand oxygen delivery with liquid oxygen (DDL) and demand oxgen delivery with portable oxygen concentrator (DDC). The CF involves considerable wastage of oxygen because oxygen is supplied during in- and exhalation. Demand oxygen delivery saves oxygen and results in a comparable oxygen saturation at rest in COPD patients. However, it is unknown, if oxygen supplementation via demand oxygen delivery is also sufficient during exercise in hypoxemic COPD patients. In addition, it has to be considered that the lower weight of demand oxygen delivery system might enable patients for higher physical activity level and mobility in daily life.
The effects of These three oxygen delivery systems shall be investigated by a randomized, controlled cross-over Trial. Every patient has to perform an Incremental Shuttle Walk Test and three Endurance Shuttle Walk Tests with three different oxygen supplementation (via CF, DDL or DDK) in randomized order.
Read the detailed description
The Principal Investigator will inform each patient about procedure, content and measurements of the study. It is obligatory that each patient participating in the study gives a written informed consent.
Following an initial incremental shuttle walk test (ISWT) in order to determine the individual maximum capacity, patients will perform three endurance shuttle walk tests (ESWT) at 85% of the maximal pace. In randomized order, patients will complete one ESWT on CF, one on DDL (liquid oxygen) and one on DDC (portable oxygen concentrator). The time between the three ESWTs will be 24 hours in order to give enough time for regeneration. All patients will use the same oxygen devices (CF: Companion 1000 (CE 0050), Chart Industries, Inc. Garfield Heights, Ohio, USA; DD [liquid oxygen]: Caire Spirit 300 (CE 0029), Chart Industries, Inc. Garfield Heights, Ohio, USA), DD [portable concentrator]: Inogen G2, California, USA) and will carry the oxygen device in a backpack. Continuous oxygen flow in liter per minute will be compared to the level of demand delivery (e.g.: 2 l/min CF will be compared to DD level 2).
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- 1 continuous flow oxygen supplementation, 2 demand delivery liquid oxygen supplementation, 3 demand delivery oxygen supplementation via concentrator
- Keywords
- COPD, Incremental Shuttle Walk Test, Endurance Shuttle Walk Test, oxygen therapy
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1 continuous flow oxygen supplementationDevice
Also called Companion 1000 Chart Industries, Inc. Garfield Heights, USA
This oxygen Supplementation is used in special order
2 demand delivery liquid oxygen supplementationDevice
Also called Caire Spirit 300 Chart Industries, Inc. Garfield Heights
This oxygen Supplementation is used in special order
3 demand delivery oxygen supplementation via concentratorDevice
Also called one oxygen concentrator, Inogen, Goleta, CA, USA
This oxygen Supplementation is used in special order
| Study group | Role | What they receive |
|---|---|---|
| COPD patients with delivery order 1, 2, 3 | Experimental | Patients on long-term oxygen therapy will perform 3 Endurance Shuttle Walk Tests on three consecutive days with one of three different Oxygen delivery devices. Receives: Device: 1 continuous flow oxygen supplementation; Device: 2 demand delivery liquid oxygen supplementation; Device: 3 demand delivery oxygen supplementation via concentrator |
| COPD patients with delivery order 2,3, 1 | Experimental | Patients on long-term oxygen therapy will perform 3 Endurance Shuttle Walk Tests on three consecutive days with one of three different Oxygen delivery devices. Receives: Device: 1 continuous flow oxygen supplementation; Device: 2 demand delivery liquid oxygen supplementation; Device: 3 demand delivery oxygen supplementation via concentrator |
| COPD patients with delivery order 3, 2, 1 | Experimental | Patients on long-term oxygen therapy will perform 3 Endurance Shuttle Walk Tests on three consecutive days with one of three different Oxygen delivery devices. Receives: Device: 1 continuous flow oxygen supplementation; Device: 2 demand delivery liquid oxygen supplementation; Device: 3 demand delivery oxygen supplementation via concentrator |
| COPD patients with delivery order 1, 3, 2 | Experimental | Patients on long-term oxygen therapy will perform 3 Endurance Shuttle Walk Tests on three consecutive days with one of three different Oxygen delivery devices. Receives: Device: 1 continuous flow oxygen supplementation; Device: 2 demand delivery liquid oxygen supplementation; Device: 3 demand delivery oxygen supplementation via concentrator |
| COPD patients with delivery order 2, 1, 3 | Experimental | Patients on long-term oxygen therapy will perform 3 Endurance Shuttle Walk Tests on three consecutive days with one of three different Oxygen delivery devices. Receives: Device: 1 continuous flow oxygen supplementation; Device: 2 demand delivery liquid oxygen supplementation; Device: 3 demand delivery oxygen supplementation via concentrator |
| COPD patients with delivery order 3, 1, 2 | Experimental | Patients on long-term oxygen therapy will perform 3 Endurance Shuttle Walk Tests on three consecutive days with one of three different Oxygen delivery devices. Receives: Device: 1 continuous flow oxygen supplementation; Device: 2 demand delivery liquid oxygen supplementation; Device: 3 demand delivery oxygen supplementation via concentrator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxygen saturation at isotime of the endurance shuttle walk test (ESWT), compared between CF (liquid oxygen) and DD (liquid oxygen)
continuous transcutaneous recording during ESWT by Sentec-Digital-Monitor
Measured: at baseline, at isotime of ESWT and at the end (maximal 20 min) of ESWT
Secondary outcomes (6)
Breathing frequency
measured by Visionox
Measured: at baseline, at isotime of ESWT and at the end (maximal 20 min) of ESWT
Inspiratory capacity
measured by Spiropalm
Measured: at baseline, at isotime of ESWT and at the end (maximal 20 min) of ESWT
Heart rate
continuous transcutaneous recording during ESWT by Sentec-Digital-Monitor
Measured: at baseline, at isotime of ESWT and at the end (maximal 20 min) of ESWT
Walking distance during ESWT
total distance walked during ESWT
Measured: at baseline, at isotime of ESWT and at the end (maximal 20 min) of ESWT
dyspnea
assessed by modified Borg scale (0 to 10)
Measured: at baseline, at isotime of ESWT and at the end (maximal 20 min) of ESWT
partial pressure of carbon dioxide
continuous transcutaneous recording during ESWT by Sentec-Digital-Monitor
Measured: at baseline, at isotime of ESWT and at the end (maximal 20 min) of ESWT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2016 (estimated)
- Study startApr 2016
- Primary completionOct 2018
- Study completionOct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 70 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, Prof. Dr., Principal investigator, Philipps University Marburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02744170
- Sponsor's protocol ID
- O2-Demand-Study
- Status last verified
- Jan 2019
- First submitted
- 8 Mar 2016
- Last updated
- 22 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Supplemental Oxygen Delivery Via Demand Versus Continuous Flow in Hypoxemic COPD Patients
- ClinicalTrials.gov ID
- NCT02744170
- Acronym / sponsor ID
- O2-Demand-Study
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- COPD, Incremental Shuttle Walk Test, Endurance Shuttle Walk Test, oxygen therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Schön Klinik Berchtesgadener LandUniversity, hospital or other
- Study start
- Apr 2016 (actual)
- Primary completion
- Oct 2018 (actual)
- Study completion
- Oct 2018 (actual)
- First posted
- 20 Apr 2016 (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.
Oxygen supplementation has been proven to be effective in hypoxemic COPD patients by increasing oxygenation and reducing dyspnea. In clinical practice there are three common oxygen delivery systems used: continuous oxygen flow (CF), demand oxygen delivery with liquid oxygen (DDL) and demand oxgen delivery with portable oxygen concentrator (DDC). The CF involves considerable wastage of oxygen because oxygen is supplied during in- and exhalation. Demand oxygen delivery saves oxygen and results in a comparable oxygen saturation at rest in COPD patients. However, it is unknown, if oxygen supplementation via demand oxygen delivery is also sufficient during exercise in hypoxemic COPD patients. In addition, it has to be considered that the lower weight of demand oxygen delivery system might enable patients for higher physical activity level and mobility in daily life.
The effects of These three oxygen delivery systems shall be investigated by a randomized, controlled cross-over Trial. Every patient has to perform an Incremental Shuttle Walk Test and three Endurance Shuttle Walk Tests with three different oxygen supplementation (via CF, DDL or DDK) in randomized order.
Detailed description
The Principal Investigator will inform each patient about procedure, content and measurements of the study. It is obligatory that each patient participating in the study gives a written informed consent.
Following an initial incremental shuttle walk test (ISWT) in order to determine the individual maximum capacity, patients will perform three endurance shuttle walk tests (ESWT) at 85% of the maximal pace. In randomized order, patients will complete one ESWT on CF, one on DDL (liquid oxygen) and one on DDC (portable oxygen concentrator). The time between the three ESWTs will be 24 hours in order to give enough time for regeneration. All patients will use the same oxygen devices (CF: Companion 1000 (CE 0050), Chart Industries, Inc. Garfield Heights, Ohio, USA; DD [liquid oxygen]: Caire Spirit 300 (CE 0029), Chart Industries, Inc. Garfield Heights, Ohio, USA), DD [portable concentrator]: Inogen G2, California, USA) and will carry the oxygen device in a backpack. Continuous oxygen flow in liter per minute will be compared to the level of demand delivery (e.g.: 2 l/min CF will be compared to DD level 2).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| COPD patients with delivery order 1, 2, 3 | Experimental | Device: 1 continuous flow oxygen supplementation, Device: 2 demand delivery liquid oxygen supplementation, Device: 3 demand delivery oxygen supplementation via concentratorPatients on long-term oxygen therapy will perform 3 Endurance Shuttle Walk Tests on three consecutive days with one of three different Oxygen delivery devices. |
| COPD patients with delivery order 2,3, 1 | Experimental | Device: 1 continuous flow oxygen supplementation, Device: 2 demand delivery liquid oxygen supplementation, Device: 3 demand delivery oxygen supplementation via concentratorPatients on long-term oxygen therapy will perform 3 Endurance Shuttle Walk Tests on three consecutive days with one of three different Oxygen delivery devices. |
| COPD patients with delivery order 3, 2, 1 | Experimental | Device: 1 continuous flow oxygen supplementation, Device: 2 demand delivery liquid oxygen supplementation, Device: 3 demand delivery oxygen supplementation via concentratorPatients on long-term oxygen therapy will perform 3 Endurance Shuttle Walk Tests on three consecutive days with one of three different Oxygen delivery devices. |
| COPD patients with delivery order 1, 3, 2 | Experimental | Device: 1 continuous flow oxygen supplementation, Device: 2 demand delivery liquid oxygen supplementation, Device: 3 demand delivery oxygen supplementation via concentratorPatients on long-term oxygen therapy will perform 3 Endurance Shuttle Walk Tests on three consecutive days with one of three different Oxygen delivery devices. |
| COPD patients with delivery order 2, 1, 3 | Experimental | Device: 1 continuous flow oxygen supplementation, Device: 2 demand delivery liquid oxygen supplementation, Device: 3 demand delivery oxygen supplementation via concentratorPatients on long-term oxygen therapy will perform 3 Endurance Shuttle Walk Tests on three consecutive days with one of three different Oxygen delivery devices. |
| COPD patients with delivery order 3, 1, 2 | Experimental | Device: 1 continuous flow oxygen supplementation, Device: 2 demand delivery liquid oxygen supplementation, Device: 3 demand delivery oxygen supplementation via concentratorPatients on long-term oxygen therapy will perform 3 Endurance Shuttle Walk Tests on three consecutive days with one of three different Oxygen delivery devices. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- COPD patients (GOLD stage III to IV) with hypoxemia at rest or during exercise (paO2<60mmHg)
- Participation in an inpatient pulmonary rehabilitation program (Schön Klinik BGL)
- Written informed consent
Key exclusion criteria (3 listed)
- General exclusion criteria for exercise tests, e.g. acute coronary syndrome, acute myo- or pericarditis, acute lung embolism, pulmonary infarction, acute uncontrolled heart insufficiency
- Signs of acute exacerbation
- Any orthopedic or neurological disabilities that prevent patient from walking
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 |
|---|---|---|
| 1 continuous flow oxygen supplementationAlso: Companion 1000 Chart Industries, Inc. Garfield Heights, USAThis oxygen Supplementation is used in special order | Device | COPD patients with delivery order 1, 2, 3, COPD patients with delivery order 1, 3, 2, COPD patients with delivery order 2, 1, 3, COPD patients with delivery order 2,3, 1, COPD patients with delivery order 3, 1, 2, COPD patients with delivery order 3, 2, 1 |
| 2 demand delivery liquid oxygen supplementationAlso: Caire Spirit 300 Chart Industries, Inc. Garfield HeightsThis oxygen Supplementation is used in special order | Device | COPD patients with delivery order 1, 2, 3, COPD patients with delivery order 1, 3, 2, COPD patients with delivery order 2, 1, 3, COPD patients with delivery order 2,3, 1, COPD patients with delivery order 3, 1, 2, COPD patients with delivery order 3, 2, 1 |
| 3 demand delivery oxygen supplementation via concentratorAlso: one oxygen concentrator, Inogen, Goleta, CA, USAThis oxygen Supplementation is used in special order | Device | COPD patients with delivery order 1, 2, 3, COPD patients with delivery order 1, 3, 2, COPD patients with delivery order 2, 1, 3, COPD patients with delivery order 2,3, 1, COPD patients with delivery order 3, 1, 2, COPD patients with delivery order 3, 2, 1 |
Primary outcome
Oxygen saturation at isotime of the endurance shuttle walk test (ESWT), compared between CF (liquid oxygen) and DD (liquid oxygen)
Time frame: at baseline, at isotime of ESWT and at the end (maximal 20 min) of ESWT
continuous transcutaneous recording during ESWT by Sentec-Digital-Monitor
6 secondary outcomes
Breathing frequency
Time frame: at baseline, at isotime of ESWT and at the end (maximal 20 min) of ESWT
Inspiratory capacity
Time frame: at baseline, at isotime of ESWT and at the end (maximal 20 min) of ESWT
Heart rate
Time frame: at baseline, at isotime of ESWT and at the end (maximal 20 min) of ESWT
Walking distance during ESWT
Time frame: at baseline, at isotime of ESWT and at the end (maximal 20 min) of ESWT
dyspnea
Time frame: at baseline, at isotime of ESWT and at the end (maximal 20 min) of ESWT
partial pressure of carbon dioxide
Time frame: at baseline, at isotime of ESWT and at the end (maximal 20 min) of ESWT
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 22 Jan 2019.
- 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.
Klaus Kenn, Prof. Dr. principal investigator
Philipps University Marburg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 1 continuous flow oxygen supplementation, 2 demand delivery liquid oxygen supplementation and 3 demand delivery oxygen supplementation via concentrator in people with Chronic Obstructive Pulmonary Disease, 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 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 22 Jan 2019. 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?
Oxygen saturation at isotime of the endurance shuttle walk test (ESWT), compared between CF (liquid oxygen) and DD (liquid oxygen) (time frame: at baseline, at isotime of ESWT and at the end (maximal 20 min) of ESWT). 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 22 Jan 2019.