COPDNCT04955561
CO2-Patterns During Hyperoxia and Physical Exercise in COPD
A study testing Oxygen therapy, Medical Air and 10L/min O2 in people with COPD, run by Schön Klinik Berchtesgadener Land at 1 site in Germany.
Trial summary
The aim of the study is to investigate a possible correlation between the change in PCO2 during a hyperoxia-test and the change in PCO2 during walking in people with COPD Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- COPD
- What is being tested?
- Oxygen therapy, Medical Air and 10L/min O2
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteGermany
- Study dates
- 13 Jul 2021to May 2022
- 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
- COPD III/ IV
- 35mmHg < PCO2 <= 55mmHg (under resting conditions, breathing room air)
- Hypoxemia (PaO2<60mmHg) under room air conditions (rest or during exercise) or SpO2 <88% during exercise
- established oxygen therapy or given indication for oxygen therapy
- written informed consent
Who cannot join
- acute exacerbation of COPD
- exercise limiting cardiac or orthopedic comorbidites
- PaO2 <50mmHg at rest, breathing room air
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Klinikum Berchtesgadener Land, Schön Kliniken
Schönau am Königssee, 83471
Tessa Schneeberger, MSc, 0049 - 8652 - 932730, tschneeberger@schoen-klinik.de
About this study
Official title: CO2-Patterns During Hyperoxia and Physical Exercise in People With Severe COPD - a Randomized, Double-blind Cross Over Trial
The aim of the study is to investigate a possible correlation between the change in PCO2 during a hyperoxia-test and the change in PCO2 during walking in people with COPD
Read the detailed description
Rationale:
Carbon dioxide partial pressure (PCO2) varies significantly in patients with advanced chronic obstructive pulmonary disease (COPD). Data from the Swedish LTOT Registry showed that PCO2 is an independent predictor for mortality and that there is a U-shaped relationship. Patients with advanced COPD who are still normocapnic at rest may still develop a clinically relevant, exercise-induced carbon dioxide (CO2) retention during exercise/ activity. It is also known that altered breathing patterns at night in COPD patients can lead to nocturnal hypercapnia, especially during REM sleep. The course of PCO2 cannot be reliably predicted by lung function parameters or resting blood gas analysis. Since exercise tests with blood gas control or nightly PCO2 monitoring are rarely performed in clinical routine, exercise induced CO2 retention often remains undetected. In the literature, there is little information on PCO2 behaviour under everyday conditions (with or without LTOT) such as rest, physical exertion and nightly sleep. Therefore, predictors that could describe the PCO2 patterns are missing. However, one former study by O'Donnel from 2002 showed that the change in CO2 under hyperoxia conditions could provide predictive information for the change in CO2 with exercise.
Objective:
Primary aim of this study is to investigate whether the change of PCO2 during a hyperoxia-test (10l/min O2 at rest) correlates with the change of PCO2 during walking exercise with either a: l/min O2 as prescribed; b: medical air; c: 10l/min O2.
Design:
This study is a randomized, controlled cross-over trial. Following an initial maximal incremental shuttle walk test (ISWT), the participant will perform 3 endurance shuttle walk tests (ESWT) at 85% of the maximum ISWT pace on three consecutive days (24h break between ESWTs). In a randomized order, participants will perform one ESWTs with O2-flow as prescribed (e.g. study day 1), one with medical air (same flow rate as prescribed oxygen) (e.g. study day 2) and one with 10l/min O2 (e.g. study day 3). An additional hyperoxia test (10l/min O2 for ten minutes; at resting condition) will be perfomed on each day prior to performing an ESWT.
- Conditions
- COPD
- Being tested
- Oxygen therapy, Medical Air, 10L/min O2
- Keywords
- CO2, oxygen, walking exercise
- 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.
Oxygen therapyOther
Supplemental O2 at rest of 10 l/min for ten minutes followed by supplemental O2 at the prescribed exercise O2-flow rate during ESWT.
Medical AirOther
Supplemental O2 at rest of 10 l/min for ten minutes followed by medical Air at prescribed O2 flow rate during ESWT.
10L/min O2Other
Supplemental O2 at rest of 10 l/min for ten minutes followed by 10L/min O2 during ESWT.
| Study group | Role | What they receive |
|---|---|---|
| Randomised to begin with oxygen-supplementation at 10L/min during ESWT | Experimental | Randomised order of tests starting with the 10L/min O2, during the ESWT followed by prescribed O2 flow rate or medical air in randomised order on seperate days Receives: Other: Oxygen therapy; Other: Medical Air; Other: 10L/min O2 |
| Randomised to begin with medical air supplementation at prescibed O2 flow rate during ESWT | Experimental | Randomised order of tests starting with the medical air during the ESWT followed by prescribed O2 flow rate or 10L/min O2 in randomised order on seperate days Receives: Other: Oxygen therapy; Other: Medical Air; Other: 10L/min O2 |
| Randomised to begin with oxygen supplementation at prescibed O2 flow rate during ESWT | Experimental | Randomised order of tests starting with the prescribed O2 flow rate, during the ESWT followed by 10L/min O2 or medical air in randomised order on seperate days Receives: Other: Oxygen therapy; Other: Medical Air; Other: 10L/min O2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in PCO2 during hyperoxia at rest
pCO2 measured by capillary blood gases taken before and after the hyperoxia test
Measured: Change from baseline to after 10 minutes breathing 10L/min oxygen
Change in PCO2 from rest to end exercise (endurance shuttle walk test)
pCO2 measured by capillary blood gases taken before and after the ESWT
Measured: Change from baseline to the end of the ESWT, up to 20 minutes
Secondary outcomes (8)
Transcutaneous partial pressure of CO2 (TcPCO2) during hyperoxia test
TcPCO2 measured by continuous transcutaneous recording via Sentec-Digital Monitor® (Sentec, Therwil, Switzerland)
Measured: Continuously from baseline to 10 minutes breathing 10L/min oxygen
Transcutaneous partial pressure of CO2 (TcPCO2) during endurance shuttle walk test
TcPCO2 measured by continuous transcutaneous recording via Sentec-Digital Monitor® (Sentec, Therwil, Switzerland)
Measured: Continuously during ESWT, up to 20 minutes
Breathing frequency during hyperoxia test
Breathing frequency during the hyperoxia test measured by ApneaLink Air™ (ResMed)
Measured: Continuously from baseline to 10 minutes breathing 10L/min oxygen
Breathing frequency during endurance shuttle walk test
Breathing frequency during the ESWT measured by ApneaLink Air™ (ResMed)
Measured: Continuously during ESWT, up to 20 minutes
Heart rate during endurance shuttle walk test
Heart rate measured by continuous transcutaneous recordung via Sentec-Digital Monitor® (Sentec, Therwil, Switzerland)
Measured: Continuously during ESWT, up to 20 minutes
Heart rate during hyperoxia test
Heart rate measured by continuous transcutaneous recordung via Sentec-Digital Monitor® (Sentec, Therwil, Switzerland)
Measured: Continuously from baseline to 10 minutes breathing 10L/min oxygen
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: Change from baseline to the end of the ESWT, up to 20 minutes
Change of inspiratory capacity during endurance shuttle walk test
IC measured by SpiroSense (Pari) before and after the ESWT
Measured: Change from baseline to the end of the ESWT, up to 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2021
- Study start13 Jul 2021
- Primary completionMay 2022 (estimated)
- Study completionMay 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 (estimated)
Sponsor and investigators
- Lead sponsor
- Schön Klinik Berchtesgadener Land
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Klaus Kenn, Philipps University Marburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04955561
- Sponsor's protocol ID
- CO2-Hyperoxia & Exercise
- Status last verified
- Jul 2021
- First submitted
- 4 May 2021
- Last updated
- 14 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CO2-Patterns During Hyperoxia and Physical Exercise in People With Severe COPD - a Randomized, Double-blind Cross Over Trial
- ClinicalTrials.gov ID
- NCT04955561
- Acronym / sponsor ID
- CO2-Hyperoxia & Exercise
- Conditions
- COPD
- Keywords
- CO2, oxygen, walking exercise
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- Schön Klinik Berchtesgadener LandUniversity, hospital or other
- Study start
- 13 Jul 2021 (actual)
- Primary completion
- May 2022 (estimated)
- Study completion
- May 2022 (estimated)
- First posted
- 9 Jul 2021 (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.
The aim of the study is to investigate a possible correlation between the change in PCO2 during a hyperoxia-test and the change in PCO2 during walking in people with COPD
Detailed description
Rationale:
Carbon dioxide partial pressure (PCO2) varies significantly in patients with advanced chronic obstructive pulmonary disease (COPD). Data from the Swedish LTOT Registry showed that PCO2 is an independent predictor for mortality and that there is a U-shaped relationship. Patients with advanced COPD who are still normocapnic at rest may still develop a clinically relevant, exercise-induced carbon dioxide (CO2) retention during exercise/ activity. It is also known that altered breathing patterns at night in COPD patients can lead to nocturnal hypercapnia, especially during REM sleep. The course of PCO2 cannot be reliably predicted by lung function parameters or resting blood gas analysis. Since exercise tests with blood gas control or nightly PCO2 monitoring are rarely performed in clinical routine, exercise induced CO2 retention often remains undetected. In the literature, there is little information on PCO2 behaviour under everyday conditions (with or without LTOT) such as rest, physical exertion and nightly sleep. Therefore, predictors that could describe the PCO2 patterns are missing. However, one former study by O'Donnel from 2002 showed that the change in CO2 under hyperoxia conditions could provide predictive information for the change in CO2 with exercise.
Objective:
Primary aim of this study is to investigate whether the change of PCO2 during a hyperoxia-test (10l/min O2 at rest) correlates with the change of PCO2 during walking exercise with either a: l/min O2 as prescribed; b: medical air; c: 10l/min O2.
Design:
This study is a randomized, controlled cross-over trial. Following an initial maximal incremental shuttle walk test (ISWT), the participant will perform 3 endurance shuttle walk tests (ESWT) at 85% of the maximum ISWT pace on three consecutive days (24h break between ESWTs). In a randomized order, participants will perform one ESWTs with O2-flow as prescribed (e.g. study day 1), one with medical air (same flow rate as prescribed oxygen) (e.g. study day 2) and one with 10l/min O2 (e.g. study day 3). An additional hyperoxia test (10l/min O2 for ten minutes; at resting condition) will be perfomed on each day prior to performing an ESWT.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Randomised to begin with oxygen-supplementation at 10L/min during ESWT | Experimental | Other: Oxygen therapy, Other: Medical Air, Other: 10L/min O2Randomised order of tests starting with the 10L/min O2, during the ESWT followed by prescribed O2 flow rate or medical air in randomised order on seperate days |
| Randomised to begin with medical air supplementation at prescibed O2 flow rate during ESWT | Experimental | Other: Oxygen therapy, Other: Medical Air, Other: 10L/min O2Randomised order of tests starting with the medical air during the ESWT followed by prescribed O2 flow rate or 10L/min O2 in randomised order on seperate days |
| Randomised to begin with oxygen supplementation at prescibed O2 flow rate during ESWT | Experimental | Other: Oxygen therapy, Other: Medical Air, Other: 10L/min O2Randomised order of tests starting with the prescribed O2 flow rate, during the ESWT followed by 10L/min O2 or medical air in randomised order on seperate days |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- COPD III/ IV
- 35mmHg < PCO2 <= 55mmHg (under resting conditions, breathing room air)
- Hypoxemia (PaO2<60mmHg) under room air conditions (rest or during exercise) or SpO2 <88% during exercise
- established oxygen therapy or given indication for oxygen therapy
- written informed consent
Key exclusion criteria (3 listed)
- acute exacerbation of COPD
- exercise limiting cardiac or orthopedic comorbidites
- PaO2 <50mmHg at rest, breathing room 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 |
|---|---|---|
| Oxygen therapySupplemental O2 at rest of 10 l/min for ten minutes followed by supplemental O2 at the prescribed exercise O2-flow rate during ESWT. | Other | Randomised to begin with medical air supplementation at prescibed O2 flow rate during ESWT, Randomised to begin with oxygen supplementation at prescibed O2 flow rate during ESWT, Randomised to begin with oxygen-supplementation at 10L/min during ESWT |
| Medical AirSupplemental O2 at rest of 10 l/min for ten minutes followed by medical Air at prescribed O2 flow rate during ESWT. | Other | Randomised to begin with medical air supplementation at prescibed O2 flow rate during ESWT, Randomised to begin with oxygen supplementation at prescibed O2 flow rate during ESWT, Randomised to begin with oxygen-supplementation at 10L/min during ESWT |
| 10L/min O2Supplemental O2 at rest of 10 l/min for ten minutes followed by 10L/min O2 during ESWT. | Other | Randomised to begin with medical air supplementation at prescibed O2 flow rate during ESWT, Randomised to begin with oxygen supplementation at prescibed O2 flow rate during ESWT, Randomised to begin with oxygen-supplementation at 10L/min during ESWT |
Primary outcome
Change in PCO2 during hyperoxia at rest
Time frame: Change from baseline to after 10 minutes breathing 10L/min oxygen
pCO2 measured by capillary blood gases taken before and after the hyperoxia test
Change in PCO2 from rest to end exercise (endurance shuttle walk test)
Time frame: Change from baseline to the end of the ESWT, up to 20 minutes
pCO2 measured by capillary blood gases taken before and after the ESWT
8 secondary outcomes
Transcutaneous partial pressure of CO2 (TcPCO2) during hyperoxia test
Time frame: Continuously from baseline to 10 minutes breathing 10L/min oxygen
Transcutaneous partial pressure of CO2 (TcPCO2) during endurance shuttle walk test
Time frame: Continuously during ESWT, up to 20 minutes
Breathing frequency during hyperoxia test
Time frame: Continuously from baseline to 10 minutes breathing 10L/min oxygen
Breathing frequency during endurance shuttle walk test
Time frame: Continuously during ESWT, up to 20 minutes
Heart rate during endurance shuttle walk test
Time frame: Continuously during ESWT, up to 20 minutes
Heart rate during hyperoxia test
Time frame: Continuously from baseline to 10 minutes breathing 10L/min oxygen
Change of capillary partial pressure of O2 (pO2) during endurance shuttle walk test
Time frame: Change from baseline to the end of the ESWT, up to 20 minutes
Change of inspiratory capacity during endurance shuttle walk test
Time frame: Change from baseline to the end of the ESWT, up to 20 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2021.
- Individual participant dataSharing planned: Yes
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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.
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, Medical Air and 10L/min O2 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 5 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: status not confirmed, as of the sponsor's last update on 14 Jul 2021. 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 Tessa Schneeberger (+498652931540 ext. +498652931540, TSchneeberger@Schoen-Klinik.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in PCO2 during hyperoxia at rest (time frame: Change from baseline to after 10 minutes breathing 10L/min oxygen). The study lists 2 primary outcomes in all. 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 14 Jul 2021.