COPDNCT03803384
Effects of an Auto-Regulating Oxygen System Compared to Constant-Flow Oxygen During Walking in Hypoxemic COPD Patients
A study testing Oxygen therapy in people with COPD, run by Schön Klinik Berchtesgadener Land at 1 site in Germany.
Trial summary
Oxygen therapy is a cornerstone in treating patients with severe chronic obstructive pulmonary disease. Usually, oxygen supplementation is delivered using constant-flow rates. Varying oxygenation levels may occur throughout patients´ changing activity. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- COPD
- What is being tested?
- Oxygen therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteGermany
- Study dates
- 7 Jan 2019to 26 Nov 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- GOLD III/ IV
- Hypoxemia (PaO2<55 mmHg) under roomair conditions (rest or during exercise) or SpO2 <88% during exercise
- established Long-term oxygen therapy or given indication for a Long-term oxygen therapy
- Age: 40 to 80 years
- Participation in an inpatient pulmonary rehabilitation program (Schoen Klinik BGL, Germany)
- Written informed consent
Who cannot join
- Acute Exacerbation of COPD
- Clinical signs of any acute cardiac comorbidity
- Not able to walk
Trial locations and contacts
1 site in 1 country.
Germany1 site
Schoen Klinik Berchtesgadener Land
Schönau am Königssee, Bavaria, 83471
About this study
Official title: Effects of an Auto-Regulating Oxygen System Compared to Constant-Flow Oxygen During Walking in Hypoxemic COPD Patients - a Randomized Controlled Trial
Oxygen therapy is a cornerstone in treating patients with severe chronic obstructive pulmonary disease. Usually, oxygen supplementation is delivered using constant-flow rates. Varying oxygenation levels may occur throughout patients´ changing activity. There is some evidence available that an auto-regulating oxygen flow system (FreeO2), which adjusts the oxygen flow automatically to prevent desoxygenation could be beneficial in comparison to a constant oxygen dose of 2 liter/min during walking. However, these possible benefits are unknown if the FreeO2 is compared to a constant oxygen dose according to the individual prescription. Therefore, the primary aim of this study is to investigate the effects of auto-regulated oxygen flow rates compared to constant oxygen flow rates as prescribed according to international guidelines on walking capacity in patients with COPD.
Read the detailed description
Rationale:
Hypoxemia is frequently observed in COPD and thus can negatively impact exercise tolerance. Supplemental oxygen or long-term oxygen therapy is recommended to ensure that the patient is still able to manage his daily life. Usually, oxygen supplementation is delivered using constant flow rates during day- and nighttime or as needed. However, studies have shown, that auto-regulated oxygen flow systems (FreeO2) may enhance the patients endurance, lower the time in severe hypoxemia and increase the time spent within the SpO2 target range.
Aim of this study is to investigate the effects off an auto-regulated oxygen flow system in hypoxemic COPD patients on the patient´s endurance, the oxygen saturation, the pCO2 blood level as well as on heart rate and breathing frequency compared to the effects off the prescribed constant flow (according to the British Thoracic Society Guidelines for Home Oxygen Use in Adults) during an endurance shuttle walk test (ESWT). Additionally, patients experience, e.g. comfort and Preference of the Oxygen-delivery System will be documented.
Design:
This study is a randomized, controlled cross-over trial. Following an initial incremental shuttle walk test (ISWT) in order to determine the participants individual maximal walking capacity, the participant will perform 2 endurance shuttle walk tests (ESWT) at 85% of the maximal walking rate. In randomized order, the participants will perform one ESWT with constant flow as prescribed and one ESWT with the auto-regulated oxygen flow system.
- Conditions
- COPD
- Being tested
- Oxygen therapy
- Keywords
- hypoxemia, exercise, oxygen, automatic oxygen-titration
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Hypoxia, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxygen therapyOther
Oxygen supply during ESWT, once with the prescribed constant oxygen flow and once using an auto-regulated oxygen flow system setting the SpO2 target at 92%.
| Study group | Role | What they receive |
|---|---|---|
| ESWT Order A and B | Experimental | First Endurance Shuttle walk test (A) with supplemental Oxygen therapy via auto-regulated oxygen flow rates (FreeO2) to maintain a oxygen saturation of 92% and second Endurance Shuttle walk (B) test with supplemental Oxygen therapy via constant oxygen flow rates Receives: Other: Oxygen therapy |
| ESWT Order B and A | Experimental | First Endurance Shuttle walk test (B) with supplemental Oxygen therapy via constant oxygen flow rates and second Endurance Shuttle walk (A) test with supplemental Oxygen therapy via auto-regulated oxygen flow rates (FreeO2) to maintain a oxygen saturation of 92% Receives: Other: Oxygen therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endurance time
Change of Walking Duration during the ESWT
Measured: Day 1 and Day 2
Secondary outcomes (8)
Change of oxygen saturation during the endurance shuttle walk test.
SpO2 measured by continuous transcutaneous recordung via Sentec-Digital Monitor® (Sentec, Therwil, Switzerland).
Measured: Day 1 and Day 2
Time to desaturation (SpO2 <=90%) and to severe desaturation (SpO2 <=85%)
SpO2 measured by continuous transcutaneous recordung via Sentec-Digital Monitor® (Sentec, Therwil, Switzerland) and FreeO2 Device.
Measured: Day 1 and Day 2
Change of capillary partial pressure of CO2 (pCO2) during endurance shuttle walk test
pCO2 measured by capillary blood gases taken before and after the ESWT.
Measured: Day 1 and Day 2
Change of capillary partial pressure of O2 (pO2) during endurance shuttle walk test
pO2 measured by capillary blood gases taken before and after the ESWT.
Measured: Day 1 and Day 2
Change of partial pressure of CO2 (pCO2) during endurance shuttle walk test
pCO2 measured by continuous transcutaneous recording via Sentec-Digital Monitor® (Sentec, Therwil, Switzerland)
Measured: Day 1 and Day 2
Change of heart rate during endurance shuttle walk test
Heart rate measured by continuous transcutaneous recordung via Sentec-Digital Monitor® (Sentec, Therwil, Switzerland).
Measured: Day 1 and Day 2
Change of breathing frequency during endurance shuttle walk test
Breathing frequency during the ESWT measured by ApneaLink Air™ (ResMed, ...)
Measured: Day 1 and Day 2
Patients Preference due to oxygen delivery system
Patients will be asked to rate their experienced comfort after each ESWT
Measured: Day 1 and Day 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2019
- Study start7 Jan 2019
- Primary completion26 Nov 2019
- Study completion26 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for COPDStudies 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, Investigator
- Enrolment
- 55 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
- NCT03803384
- Sponsor's protocol ID
- COPD FreeO2-Study
- Status last verified
- Nov 2019
- First submitted
- 7 Jan 2019
- Last updated
- 27 Nov 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lellouche F, L'Her E, Bouchard PA, Brouillard C, Maltais F. Automatic Oxygen Titration During Walking in Subjects With COPD: A Randomized Crossover Controlled Study. Respir Care. 2016 Nov;61(11):1456-1464. doi: 10.4187/respcare.04406. Epub 2016 Oct 18.
PubMed 27794080Schneeberger T, Jarosch I, Leitl D, Gloeckl R, Hitzl W, Dennis CJ, Geyer T, Criee CP, Koczulla AR, Kenn K. Automatic oxygen titration versus constant oxygen flow rates during walking in COPD: a randomised controlled, double-blind, crossover trial. Thorax. 2023 Apr;78(4):326-334. doi: 10.1136/thoraxjnl-2020-216509. Epub 2021 Oct 16.
PubMed 34656996
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of an Auto-Regulating Oxygen System Compared to Constant-Flow Oxygen During Walking in Hypoxemic COPD Patients - a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03803384
- Acronym / sponsor ID
- COPD FreeO2-Study
- Conditions
- COPD
- Keywords
- hypoxemia, exercise, oxygen, automatic oxygen-titration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Schön Klinik Berchtesgadener LandUniversity, hospital or other
- Study start
- 7 Jan 2019 (actual)
- Primary completion
- 26 Nov 2019 (actual)
- Study completion
- 26 Nov 2019 (actual)
- First posted
- 14 Jan 2019 (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.
Oxygen therapy is a cornerstone in treating patients with severe chronic obstructive pulmonary disease. Usually, oxygen supplementation is delivered using constant-flow rates. Varying oxygenation levels may occur throughout patients´ changing activity. There is some evidence available that an auto-regulating oxygen flow system (FreeO2), which adjusts the oxygen flow automatically to prevent desoxygenation could be beneficial in comparison to a constant oxygen dose of 2 liter/min during walking. However, these possible benefits are unknown if the FreeO2 is compared to a constant oxygen dose according to the individual prescription. Therefore, the primary aim of this study is to investigate the effects of auto-regulated oxygen flow rates compared to constant oxygen flow rates as prescribed according to international guidelines on walking capacity in patients with COPD.
Detailed description
Rationale:
Hypoxemia is frequently observed in COPD and thus can negatively impact exercise tolerance. Supplemental oxygen or long-term oxygen therapy is recommended to ensure that the patient is still able to manage his daily life. Usually, oxygen supplementation is delivered using constant flow rates during day- and nighttime or as needed. However, studies have shown, that auto-regulated oxygen flow systems (FreeO2) may enhance the patients endurance, lower the time in severe hypoxemia and increase the time spent within the SpO2 target range.
Aim of this study is to investigate the effects off an auto-regulated oxygen flow system in hypoxemic COPD patients on the patient´s endurance, the oxygen saturation, the pCO2 blood level as well as on heart rate and breathing frequency compared to the effects off the prescribed constant flow (according to the British Thoracic Society Guidelines for Home Oxygen Use in Adults) during an endurance shuttle walk test (ESWT). Additionally, patients experience, e.g. comfort and Preference of the Oxygen-delivery System will be documented.
Design:
This study is a randomized, controlled cross-over trial. Following an initial incremental shuttle walk test (ISWT) in order to determine the participants individual maximal walking capacity, the participant will perform 2 endurance shuttle walk tests (ESWT) at 85% of the maximal walking rate. In randomized order, the participants will perform one ESWT with constant flow as prescribed and one ESWT with the auto-regulated oxygen flow system.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ESWT Order A and B | Experimental | Other: Oxygen therapyFirst Endurance Shuttle walk test (A) with supplemental Oxygen therapy via auto-regulated oxygen flow rates (FreeO2) to maintain a oxygen saturation of 92% and second Endurance Shuttle walk (B) test with supplemental Oxygen therapy via constant oxygen flow rates |
| ESWT Order B and A | Experimental | Other: Oxygen therapyFirst Endurance Shuttle walk test (B) with supplemental Oxygen therapy via constant oxygen flow rates and second Endurance Shuttle walk (A) test with supplemental Oxygen therapy via auto-regulated oxygen flow rates (FreeO2) to maintain a oxygen saturation of 92% |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- GOLD III/ IV
- Hypoxemia (PaO2<55 mmHg) under roomair conditions (rest or during exercise) or SpO2 <88% during exercise
- established Long-term oxygen therapy or given indication for a Long-term oxygen therapy
- Age: 40 to 80 years
- Participation in an inpatient pulmonary rehabilitation program (Schoen Klinik BGL, Germany)
Key exclusion criteria (3 listed)
- Acute Exacerbation of COPD
- Clinical signs of any acute cardiac comorbidity
- Not able to walk
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 |
|---|---|---|
| Oxygen therapyOxygen supply during ESWT, once with the prescribed constant oxygen flow and once using an auto-regulated oxygen flow system setting the SpO2 target at 92%. | Other | ESWT Order A and B, ESWT Order B and A |
Primary outcome
Endurance time
Time frame: Day 1 and Day 2
Change of Walking Duration during the ESWT
8 secondary outcomes
Change of oxygen saturation during the endurance shuttle walk test.
Time frame: Day 1 and Day 2
Time to desaturation (SpO2 <=90%) and to severe desaturation (SpO2 <=85%)
Time frame: Day 1 and Day 2
Change of capillary partial pressure of CO2 (pCO2) during endurance shuttle walk test
Time frame: Day 1 and Day 2
Change of capillary partial pressure of O2 (pO2) during endurance shuttle walk test
Time frame: Day 1 and Day 2
Change of partial pressure of CO2 (pCO2) during endurance shuttle walk test
Time frame: Day 1 and Day 2
Change of heart rate during endurance shuttle walk test
Time frame: Day 1 and Day 2
Change of breathing frequency during endurance shuttle walk test
Time frame: Day 1 and Day 2
Patients Preference due to oxygen delivery system
Time frame: Day 1 and Day 2
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 27 Nov 2019.
- Background: PubMed 27794080Lellouche F, L'Her E, Bouchard PA, Brouillard C, Maltais F. Automatic Oxygen Titration During Walking in Subjects With COPD: A Randomized Crossover Controlled Study. Respir Care. 2016 Nov;61(11):1456-1464. doi: 10.4187/respcare.04406. Epub 2016 Oct 18.
- Derived from this study: PubMed 34656996Schneeberger T, Jarosch I, Leitl D, Gloeckl R, Hitzl W, Dennis CJ, Geyer T, Criee CP, Koczulla AR, Kenn K. Automatic oxygen titration versus constant oxygen flow rates during walking in COPD: a randomised controlled, double-blind, crossover trial. Thorax. 2023 Apr;78(4):326-334. doi: 10.1136/thoraxjnl-2020-216509. Epub 2021 Oct 16.
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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 Oxygen therapy in people with COPD, 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 6 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 27 Nov 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?
Endurance time (time frame: Day 1 and Day 2). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03803384, which also lists 2 linked publications.
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 27 Nov 2019.