HypoxaemiaNCT06545851
Effects of an Automatic Oxygen Titration System in People With Hypoxemia During Exercise Training
A study testing Oxygen therapy - constant oxygen flow and Oxygen therapy - automatic titrating oxygen flow in people with Hypoxaemia and Chronic Lung Disease, run by Schön Klinik Berchtesgadener Land at 1 site in Germany.
Trial summary
Long-term oxygen therapy is a fundamental treatment modality for patients with chronic hypoxaemic lung disease. Typically, oxygen is administered at a constant flow rate. However, due to fluctuating activity levels, patients' oxygenation status can vary, potentially leading to oxygen desaturation and increased… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hypoxaemia, Chronic Lung Disease
- What is being tested?
- Oxygen therapy - constant oxygen flow and Oxygen therapy - automatic titrating oxygen flow
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteGermany
- Study dates
- 14 Aug 2023to 30 Nov 2024
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic lung disease
- Hypoxemia (pO2< 55mmHg) under room air conditions (rest or during exercise) or SpO2<88% during exercise
- established Long-term oxygen therapy or given indication for a Long-term oxygen therapy/ supplemental oxygen therapy for exercise
- Age: 18 to 80 years
- Participation in an inpatient pulmonary rehabilitation program (Schoen Klinik BGL, Germany)
- Written informed consent
Who cannot join
- Acute exacerbation of underlying pulmonary disease requiring cessation of exercise training.
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Klinikum Berchtesgadener Land, Schön Kliniken
Schönau am Königssee, Bavaria, 83471
Tessa Schneeberger, PhD, 0049 - 8652 - 932730, tschneeberger@schoen-klinik.de
About this study
Official title: Automatic Oxygen Titration Versus Constant Oxygen Flow Rates During Exercise Training in Hypoxemic People With Chronic Lung Disease - a Randomized, Double-blind, Controlled Cross-over Pilot Study
Long-term oxygen therapy is a fundamental treatment modality for patients with chronic hypoxaemic lung disease. Typically, oxygen is administered at a constant flow rate. However, due to fluctuating activity levels, patients' oxygenation status can vary, potentially leading to oxygen desaturation and increased dyspnoea.
Emerging evidence suggests that automatic oxygen titration - a method of adjusting oxygen flow in response to current oxygen saturation - may have acute advantages over constant oxygen flow.
The primary objective of this study is to investigate the effect of automatic oxygen titration compared to prescribed constant oxygen flow rates on patients' perceived dyspnoea during exercise endurance training.
Read the detailed description
Rationale:
Hypoxaemia is common in people with chronic lung disease and can affect exercise tolerance. Oxygen therapy is then recommended.
Oxygen supplementation is usually delivered at constant oxygen flow rates. Only a few studies have investigated the short-term effects of automated oxygen delivery compared to a constant oxygen flow rate during exercise tests (e.g. 6-minute walk test, shuttle walk tests). These studies have shown that automatic oxygen delivery can lead to an acute increase in exercise capacity, including an improvement in the perception of breathlessness. The use of automated oxygen delivery during endurance exercise has not been studied. The most common reason for stopping prolonged exercise in patients with chronic lung disease is dyspnoea. Therefore, the use of automatic oxygen delivery in a pulmonary rehabilitation clinic could be beneficial in the context of personalised therapy for patients requiring oxygen if it further reduces dyspnoea, potentially enabling the patient to train their endurance even better.
Therefore, the primary aim of this study was to investigate whether the use of automatic oxygen supplementation versus constant oxygen supplementation has a different effect on the perception of dyspnoea in patients with hypoxaemia during endurance exercise.
Design:
This study is designed as a randomised, double-blind, controlled cross-over trial. Participants will first undergo a cycle-based peak work rate test to determine their individual maximal peak work rate. They then take part in two sets of five endurance training sessions. One set is performed with a constant oxygen flow prescribed for each participant, while the other uses automatic oxygen titration. The order in which these two sessions are performed is randomised.
- Conditions
- Hypoxaemia, Chronic Lung Disease
- Being tested
- Oxygen therapy - constant oxygen flow, Oxygen therapy - automatic titrating oxygen flow
- Medical subject headings
- Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxygen therapy - constant oxygen flowOther
During five exercise training sessions, oxygen therapy is delivered via prescribed constant oxygen flow
Oxygen therapy - automatic titrating oxygen flowOther
During five exercise sessions, oxygen therapy is delivered via an automatically titrated oxygen flow rate to maintain an SpO2 target of 90-94%.
| Study group | Role | What they receive |
|---|---|---|
| Excercise Training Order A and B | Experimental | The first series of five exercise trainings (A) involves supplemental oxygen therapy, with automatically titrated oxygen flow rates to maintain an oxygen saturation of 90-94% (A). The second series of five exercise trainings employs supplemental oxygen therapy with constant flow rates (B), as prescribed. Receives: Other: Oxygen therapy - constant oxygen flow; Other: Oxygen therapy - automatic titrating oxygen flow |
| Excercise Training Order B and A | Experimental | The first series of five exercise trainings employs supplemental oxygen therapy with constant flow rates (B), as prescribed.The second five series of five exercise trainings involves supplemental oxygen therapy, with automatically titrated oxygen flow rates to maintain an oxygen saturation of 90-94% (A). Receives: Other: Oxygen therapy - constant oxygen flow; Other: Oxygen therapy - automatic titrating oxygen flow |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dyspnea
Change of dyspnea sensation rated by modified Borg scale (0 to 10) taken before and after exercise training
Measured: Day 1 to 5 and 6 to 10
Secondary outcomes (9)
Change of oxygen saturation (SpO2) during exercise training
SpO2 measured by continuous transcutaneous recordung via Sentec-Digital Monitor® (Sentec, Therwil, Switzerland).
Measured: Day 1 to 5 and 6 to 10
Change of transcutaneous partial CO2 pressure (TcPCO2) during exercise training
TcPCO2 measured by continuous transcutaneous recording via Sentec-Digital Monitor® (Sentec, Therwil, Switzerland)
Measured: Day 1 to 5 and 6 to 10
Change of heart rate during exercise training
Heart rate measured by continuous transcutaneous recordung via Sentec-Digital Monitor® (Sentec, Therwil, Switzerland).
Measured: Day 1 to 5 and 6 to 10
Change of capillary partial pressure of CO2 (pCO2) during exercise training
pCO2 measured by capillary blood gases taken before and after the exercise training
Measured: Day 1 to 5 and 6 to 10
Change of capillary partial pressure of O2 (pO2) during exercise training
pO2 measured by capillary blood gases taken before and after the exercise training
Measured: Day 1 to 5 and 6 to 10
Change of inspiratory capacity (IC) during exercise training
IC measured by Spirometry taken before and after exercise training via SpiroSense Pro® (Pari, Starnberg, Germany)
Measured: Day 1 to 5 and 6 to 10
Time to desaturation (SpO2 <=90%) and to severe desaturation (SpO2 <=85%) during exercise training
SpO2 measured by continuous transcutaneous recordung via Sentec-Digital Monitor® (Sentec, Therwil, Switzerland)
Measured: Day 1 to 5 and 6 to 10
Assessment of leg fatigue via BORG scale
Change of leg fatigue assessed by modified Borg scale (0 to 10) taken before and after exercise training
Measured: Day 1 to 5 and 6 to 10
Patients sensation regarding the oxygen delivery system
Patients will be asked to rate their experienced comfort after Session 1 and Session 2 via a 5-point Likert Skale: strongly agree, agree, neutral, disagree, strongly disagree
Measured: Day 5 and 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2024
- Study start14 Aug 2023
- Primary completion30 Nov 2024 (estimated)
- Study completion30 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HypoxaemiaStudies 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
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Schön Klinik Berchtesgadener Land
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr. Andreas Rembert Koczulla, Schön Klinik Berchtesgadener Land
- Investigators
- Andreas Rembert Koczulla, Prof. Dr., Principal investigator, Philipps University Marburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06545851
- Sponsor's protocol ID
- O2matic exercise training
- Status last verified
- Aug 2024
- First submitted
- 8 Aug 2023
- Last updated
- 13 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kofod LM, Westerdahl E, Kristensen MT, Brocki BC, Ringbaek T, Hansen EF. Effect of Automated Oxygen Titration during Walking on Dyspnea and Endurance in Chronic Hypoxemic Patients with COPD: A Randomized Crossover Trial. J Clin Med. 2021 Oct 20;10(21):4820. doi: 10.3390/jcm10214820.
PubMed 34768338Schneeberger 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 34656996Vivodtzev I, L'Her E, Vottero G, Yankoff C, Tamisier R, Maltais F, Lellouche F, Pepin JL. Automated O2 titration improves exercise capacity in patients with hypercapnic chronic obstructive pulmonary disease: a randomised controlled cross-over trial. Thorax. 2019 Mar;74(3):298-301. doi: 10.1136/thoraxjnl-2018-211967. Epub 2018 Aug 30.
PubMed 30166425
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Automatic Oxygen Titration Versus Constant Oxygen Flow Rates During Exercise Training in Hypoxemic People With Chronic Lung Disease - a Randomized, Double-blind, Controlled Cross-over Pilot Study
- ClinicalTrials.gov ID
- NCT06545851
- Acronym / sponsor ID
- O2matic exercise training
- Conditions
- Hypoxaemia, Chronic Lung Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Schön Klinik Berchtesgadener LandUniversity, hospital or other
- Study start
- 14 Aug 2023 (actual)
- Primary completion
- 30 Nov 2024 (estimated)
- Study completion
- 30 Nov 2024 (estimated)
- First posted
- 9 Aug 2024 (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.
Long-term oxygen therapy is a fundamental treatment modality for patients with chronic hypoxaemic lung disease. Typically, oxygen is administered at a constant flow rate. However, due to fluctuating activity levels, patients' oxygenation status can vary, potentially leading to oxygen desaturation and increased dyspnoea.
Emerging evidence suggests that automatic oxygen titration - a method of adjusting oxygen flow in response to current oxygen saturation - may have acute advantages over constant oxygen flow.
The primary objective of this study is to investigate the effect of automatic oxygen titration compared to prescribed constant oxygen flow rates on patients' perceived dyspnoea during exercise endurance training.
Detailed description
Rationale:
Hypoxaemia is common in people with chronic lung disease and can affect exercise tolerance. Oxygen therapy is then recommended.
Oxygen supplementation is usually delivered at constant oxygen flow rates. Only a few studies have investigated the short-term effects of automated oxygen delivery compared to a constant oxygen flow rate during exercise tests (e.g. 6-minute walk test, shuttle walk tests). These studies have shown that automatic oxygen delivery can lead to an acute increase in exercise capacity, including an improvement in the perception of breathlessness. The use of automated oxygen delivery during endurance exercise has not been studied. The most common reason for stopping prolonged exercise in patients with chronic lung disease is dyspnoea. Therefore, the use of automatic oxygen delivery in a pulmonary rehabilitation clinic could be beneficial in the context of personalised therapy for patients requiring oxygen if it further reduces dyspnoea, potentially enabling the patient to train their endurance even better.
Therefore, the primary aim of this study was to investigate whether the use of automatic oxygen supplementation versus constant oxygen supplementation has a different effect on the perception of dyspnoea in patients with hypoxaemia during endurance exercise.
Design:
This study is designed as a randomised, double-blind, controlled cross-over trial. Participants will first undergo a cycle-based peak work rate test to determine their individual maximal peak work rate. They then take part in two sets of five endurance training sessions. One set is performed with a constant oxygen flow prescribed for each participant, while the other uses automatic oxygen titration. The order in which these two sessions are performed is randomised.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Excercise Training Order A and B | Experimental | Other: Oxygen therapy - constant oxygen flow, Other: Oxygen therapy - automatic titrating oxygen flowThe first series of five exercise trainings (A) involves supplemental oxygen therapy, with automatically titrated oxygen flow rates to maintain an oxygen saturation of 90-94% (A). The second series of five exercise trainings employs supplemental oxygen therapy with constant flow rates (B), as prescribed. |
| Excercise Training Order B and A | Experimental | Other: Oxygen therapy - constant oxygen flow, Other: Oxygen therapy - automatic titrating oxygen flowThe first series of five exercise trainings employs supplemental oxygen therapy with constant flow rates (B), as prescribed.The second five series of five exercise trainings involves supplemental oxygen therapy, with automatically titrated oxygen flow rates to maintain an oxygen saturation of 90-94% (A). |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Chronic lung disease
- Hypoxemia (pO2< 55mmHg) under room air conditions (rest or during exercise) or SpO2<88% during exercise
- established Long-term oxygen therapy or given indication for a Long-term oxygen therapy/ supplemental oxygen therapy for exercise
- Age: 18 to 80 years
- Participation in an inpatient pulmonary rehabilitation program (Schoen Klinik BGL, Germany)
Key exclusion criteria (1 listed)
- Acute exacerbation of underlying pulmonary disease requiring cessation of exercise training.
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 therapy - constant oxygen flowDuring five exercise training sessions, oxygen therapy is delivered via prescribed constant oxygen flow | Other | Excercise Training Order A and B, Excercise Training Order B and A |
| Oxygen therapy - automatic titrating oxygen flowDuring five exercise sessions, oxygen therapy is delivered via an automatically titrated oxygen flow rate to maintain an SpO2 target of 90-94%. | Other | Excercise Training Order A and B, Excercise Training Order B and A |
Primary outcome
Dyspnea
Time frame: Day 1 to 5 and 6 to 10
Change of dyspnea sensation rated by modified Borg scale (0 to 10) taken before and after exercise training
9 secondary outcomes
Change of oxygen saturation (SpO2) during exercise training
Time frame: Day 1 to 5 and 6 to 10
Change of transcutaneous partial CO2 pressure (TcPCO2) during exercise training
Time frame: Day 1 to 5 and 6 to 10
Change of heart rate during exercise training
Time frame: Day 1 to 5 and 6 to 10
Change of capillary partial pressure of CO2 (pCO2) during exercise training
Time frame: Day 1 to 5 and 6 to 10
Change of capillary partial pressure of O2 (pO2) during exercise training
Time frame: Day 1 to 5 and 6 to 10
Change of inspiratory capacity (IC) during exercise training
Time frame: Day 1 to 5 and 6 to 10
Time to desaturation (SpO2 <=90%) and to severe desaturation (SpO2 <=85%) during exercise training
Time frame: Day 1 to 5 and 6 to 10
Assessment of leg fatigue via BORG scale
Time frame: Day 1 to 5 and 6 to 10
Patients sensation regarding the oxygen delivery system
Time frame: Day 5 and 10
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2024.
- Background: PubMed 34768338Kofod LM, Westerdahl E, Kristensen MT, Brocki BC, Ringbaek T, Hansen EF. Effect of Automated Oxygen Titration during Walking on Dyspnea and Endurance in Chronic Hypoxemic Patients with COPD: A Randomized Crossover Trial. J Clin Med. 2021 Oct 20;10(21):4820. doi: 10.3390/jcm10214820.
- Background: 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.
- Background: PubMed 30166425Vivodtzev I, L'Her E, Vottero G, Yankoff C, Tamisier R, Maltais F, Lellouche F, Pepin JL. Automated O2 titration improves exercise capacity in patients with hypercapnic chronic obstructive pulmonary disease: a randomised controlled cross-over trial. Thorax. 2019 Mar;74(3):298-301. doi: 10.1136/thoraxjnl-2018-211967. Epub 2018 Aug 30.
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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.
Andreas Rembert Koczulla, 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 - constant oxygen flow and Oxygen therapy - automatic titrating oxygen flow in people with Hypoxaemia and Chronic Lung 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 6 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 13 Aug 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andreas Rembert Koczulla, Prof. Dr. (0049-8652-932730, rkoczulla@schoen-klinik.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dyspnea (time frame: Day 1 to 5 and 6 to 10). 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 NCT06545851, which also lists 3 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 13 Aug 2024.