HemoglobinsNCT04189250
Comparison of the Automatized and the Optimized Carbon Monoxid Rebreathing Protocol
A study testing Automatized carbonmonoxide rebreathing machine - OpCO Detalo instruments in people with Hemoglobins, run by Swiss Federal Institute of Sport Magglingen at 1 site in Switzerland.
Trial summary
The aim of this study is the comparison of two measurement protocols determining hemoglobin mass with two different blood sampling strategies.Both protocols are based on the principle of the carbonmonoxid (CO) rebreathing method. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hemoglobins
- What is being tested?
- Automatized carbonmonoxide rebreathing machine - OpCO Detalo instruments
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 31 participants
- Where
- 1 siteSwitzerland
- Study dates
- 20 Jan 2020to 1 Aug 2020
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age 18 or higher
- healthy (self-reported)
- women and men
Who cannot join
- smoker
- implementation of high altitude training six weeks before and during the study
- sickness before and during the study
- blood donation 6 weeks before and during the study
- pregnancy
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
Swiss Federal Instistiution of Sport
Magglingen
Jon Wehrlin, +58 4676125, jon.wehrlin@baspo.admin.ch
Katja Kellenberger, +41792782109, katja.kellenberger@baspo.admin.ch
About this study
Official title: Comparison of the Automatized and the Optimized Carbon Monoxid Rebreathing Protocol Determining Hemoglobinmass With Capillary and Venous Blood Sampling
The aim of this study is the comparison of two measurement protocols determining hemoglobin mass with two different blood sampling strategies.Both protocols are based on the principle of the carbonmonoxid (CO) rebreathing method. During this measurement, CO is inhaled for a specific time period by the subject in a closed circuit and it is used as a marker to tag circulating hemoglobin.
Read the detailed description
The optimized CO rebreathing protocol (oCO) will be compared against the automatized CO rebreathing protocol (aCO). Although theses two protocols using the same method, they show some relevant differences.
The oCO use a 2 minutes rebreathing period in a seated position and capillary blood is taken. The aCO use a 10 minutes rebreathing period in a supine position and venous blood samples are taken.
It is essential to know to what extent the aCO with capillary or venous blood sampling with different rebreathing time and position compared to oCO will influence the provided hemoglobin mass values. It is important to ensure the comparability of formely hemoglobinmass data measured using oCO with hemoglobinmass data measured using aCO for scientific research.
- Conditions
- Hemoglobins
- Being tested
- Automatized carbonmonoxide rebreathing machine - OpCO Detalo instruments
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Automatized carbonmonoxide rebreathing machine - OpCO Detalo instrumentsDevice
The automatized protocol (aCO) will be conducted with automated system OpCO of Detalo instruments. The intended use of the OpCO Detalo instrument is to quantify hemoglobin mass in human. The principle behind the machine is the widely used CO rebreathing technique. The machine applies automatically the desired CO dose to the patient to determine hemoglobin mass. The Detalo Instruments OpCO is certified conform to the following CE norms: Electromagentic compabilitiy: DIN EN 60601-1-2 and electrical Safety test: LVD 2014/35/EU.
| Study group | Role | What they receive |
|---|---|---|
| Optimized carbonmonoxid rebreathing protocol (oCO) | Placebo comparator | 2 min rebreathing period seated position capillary blood sampling Receives: Device: Automatized carbonmonoxide rebreathing machine - OpCO Detalo instruments |
| Automatized carbonmonoxide rebreathing protocol (aCO) | Active comparator | 10 minutes rebreathing period supine position venous blood sampling Receives: Device: Automatized carbonmonoxide rebreathing machine - OpCO Detalo instruments |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of two CO rebreathing protocols (aCO and oCO)
The aim is to assess the confidence interval of aCO with a ten min rebreathing period in supine position compared to oCO with a two min seated rebreathing period. The mean difference in hemoglobin mass will be determined, using the aCO and oCO.
Measured: During data collection (3 months)
Comparison of capillary and venous bloodsampling
The aim is to compare capillary and venous blood samples collected simultaneously during aCO. The goal is to determine, if the site of blood sampling alters the measured carboxy-hemoglobin and hence the calculated hemoglobin mass.
The outcome will be the confidence interval of mean difference measured with capillary and venous blood sampling.
Measured: During data collection (3 months)
Secondary outcomes (1)
Reliability of aCO and oCO
The aim is the determination of the reliability of aCO and oCO by implementing double measurements for both protocols. The coefficient of variation (CV) of hemoglobin mass measured for aCO and oCO will be a further outcome of the study.
Measured: During data collection (3 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2019
- Study start20 Jan 2020
- Primary completion20 Apr 2020 (estimated)
- Study completion1 Aug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for HemoglobinsStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 31 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Swiss Federal Institute of Sport Magglingen
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Jon Wehrlin, Dr. scient., MSc., Principal investigator, Swiss Federal Institute of Sport Magglingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04189250
- Sponsor's protocol ID
- COMP_aCO_oCO
- Status last verified
- Mar 2020
- First submitted
- 3 Dec 2019
- Last updated
- 11 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Schmidt W, Prommer N. The optimised CO-rebreathing method: a new tool to determine total haemoglobin mass routinely. Eur J Appl Physiol. 2005 Dec;95(5-6):486-95. doi: 10.1007/s00421-005-0050-3. Epub 2005 Oct 13.
PubMed 16222540Fagoni N, Breenfeldt Andersen A, Oberholzer L, Haider T, Meinild Lundby AK, Lundby C. Reliability and validity of non-invasive determined haemoglobin mass and blood volumes. Clin Physiol Funct Imaging. 2018 Mar;38(2):240-245. doi: 10.1111/cpf.12406. Epub 2017 Jan 30.
PubMed 28135764Siebenmann C, Keiser S, Robach P, Lundby C. CORP: The assessment of total hemoglobin mass by carbon monoxide rebreathing. J Appl Physiol (1985). 2017 Sep 1;123(3):645-654. doi: 10.1152/japplphysiol.00185.2017. Epub 2017 Jun 29.
PubMed 28663373Steiner T, Wehrlin JP. Comparability of haemoglobin mass measured with different carbon monoxide-based rebreathing procedures and calculations. Scand J Clin Lab Invest. 2011 Feb;71(1):19-29. doi: 10.3109/00365513.2010.534174. Epub 2010 Nov 23.
PubMed 21091271
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Automatized and the Optimized Carbon Monoxid Rebreathing Protocol Determining Hemoglobinmass With Capillary and Venous Blood Sampling
- ClinicalTrials.gov ID
- NCT04189250
- Acronym / sponsor ID
- COMP_aCO_oCO
- Conditions
- Hemoglobins
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 31 participants (estimated)
- Lead sponsor
- Swiss Federal Institute of Sport MagglingenOther government
- Study start
- 20 Jan 2020 (actual)
- Primary completion
- 20 Apr 2020 (estimated)
- Study completion
- 1 Aug 2020 (estimated)
- First posted
- 6 Dec 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.
The aim of this study is the comparison of two measurement protocols determining hemoglobin mass with two different blood sampling strategies.Both protocols are based on the principle of the carbonmonoxid (CO) rebreathing method. During this measurement, CO is inhaled for a specific time period by the subject in a closed circuit and it is used as a marker to tag circulating hemoglobin.
Detailed description
The optimized CO rebreathing protocol (oCO) will be compared against the automatized CO rebreathing protocol (aCO). Although theses two protocols using the same method, they show some relevant differences.
The oCO use a 2 minutes rebreathing period in a seated position and capillary blood is taken. The aCO use a 10 minutes rebreathing period in a supine position and venous blood samples are taken.
It is essential to know to what extent the aCO with capillary or venous blood sampling with different rebreathing time and position compared to oCO will influence the provided hemoglobin mass values. It is important to ensure the comparability of formely hemoglobinmass data measured using oCO with hemoglobinmass data measured using aCO for scientific research.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Optimized carbonmonoxid rebreathing protocol (oCO) | Placebo comparator | Device: Automatized carbonmonoxide rebreathing machine - OpCO Detalo instruments2 min rebreathing period seated position capillary blood sampling |
| Automatized carbonmonoxide rebreathing protocol (aCO) | Active comparator | Device: Automatized carbonmonoxide rebreathing machine - OpCO Detalo instruments10 minutes rebreathing period supine position venous blood sampling |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age 18 or higher
- healthy (self-reported)
- women and men
Key exclusion criteria (5 listed)
- smoker
- implementation of high altitude training six weeks before and during the study
- sickness before and during the study
- blood donation 6 weeks before and during the study
- pregnancy
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 |
|---|---|---|
| Automatized carbonmonoxide rebreathing machine - OpCO Detalo instrumentsThe automatized protocol (aCO) will be conducted with automated system OpCO of Detalo instruments. The intended use of the OpCO Detalo instrument is to quantify hemoglobin mass in human. The principle behind the machine is the widely used CO rebreathing technique. The machine applies automatically the desired CO dose to the patient to determine hemoglobin mass. The Detalo Instruments OpCO is certified conform to the following CE norms: Electromagentic compabilitiy: DIN EN 60601-1-2 and electrical Safety test: LVD 2014/35/EU. | Device | Automatized carbonmonoxide rebreathing protocol (aCO), Optimized carbonmonoxid rebreathing protocol (oCO) |
Primary outcome
Comparison of two CO rebreathing protocols (aCO and oCO)
Time frame: During data collection (3 months)
The aim is to assess the confidence interval of aCO with a ten min rebreathing period in supine position compared to oCO with a two min seated rebreathing period. The mean difference in hemoglobin mass will be determined, using the aCO and oCO.
Comparison of capillary and venous bloodsampling
Time frame: During data collection (3 months)
The aim is to compare capillary and venous blood samples collected simultaneously during aCO. The goal is to determine, if the site of blood sampling alters the measured carboxy-hemoglobin and hence the calculated hemoglobin mass. The outcome will be the confidence interval of mean difference measured with capillary and venous blood sampling.
1 secondary outcome
Reliability of aCO and oCO
Time frame: During data collection (3 months)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2020.
- Background: PubMed 16222540Schmidt W, Prommer N. The optimised CO-rebreathing method: a new tool to determine total haemoglobin mass routinely. Eur J Appl Physiol. 2005 Dec;95(5-6):486-95. doi: 10.1007/s00421-005-0050-3. Epub 2005 Oct 13.
- Background: PubMed 28135764Fagoni N, Breenfeldt Andersen A, Oberholzer L, Haider T, Meinild Lundby AK, Lundby C. Reliability and validity of non-invasive determined haemoglobin mass and blood volumes. Clin Physiol Funct Imaging. 2018 Mar;38(2):240-245. doi: 10.1111/cpf.12406. Epub 2017 Jan 30.
- Background: PubMed 28663373Siebenmann C, Keiser S, Robach P, Lundby C. CORP: The assessment of total hemoglobin mass by carbon monoxide rebreathing. J Appl Physiol (1985). 2017 Sep 1;123(3):645-654. doi: 10.1152/japplphysiol.00185.2017. Epub 2017 Jun 29.
- Background: PubMed 21091271Steiner T, Wehrlin JP. Comparability of haemoglobin mass measured with different carbon monoxide-based rebreathing procedures and calculations. Scand J Clin Lab Invest. 2011 Feb;71(1):19-29. doi: 10.3109/00365513.2010.534174. Epub 2010 Nov 23.
- 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.
Jon Wehrlin, Dr. scient., MSc. principal investigator
Swiss Federal Institute of Sport Magglingen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Automatized carbonmonoxide rebreathing machine - OpCO Detalo instruments in people with Hemoglobins, run by Swiss Federal Institute of Sport Magglingen at 1 site in Switzerland.
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 5 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 11 Mar 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 Switzerland. 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. Some participants in this study may receive a placebo. 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 Jon Wehrlin, Dr. scient., MSc. (+41 58 467 61 25, jon.wehrlin@baspo.admin.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of two CO rebreathing protocols (aCO and oCO) (time frame: During data collection (3 months)). 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?
On the ClinicalTrials.gov record for NCT04189250, which also lists 4 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 11 Mar 2020.