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Comparison of the Automatized and the Optimized Carbon Monoxid Rebreathing Protocol

Comparison of the Automatized and the Optimized Carbon Monoxid Rebreathing Protocol Determining Hemoglobinmass With Capillary and Venous Blood Sampling

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04189250
Enrollment
31
Registered
2019-12-06
Start date
2020-01-20
Completion date
2020-08-01
Last updated
2020-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hemoglobins

Brief 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. 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.

Interventions

DEVICEAutomatized carbonmonoxide rebreathing machine - OpCO Detalo instruments

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.

Sponsors

Swiss Federal Institute of Sport Magglingen
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* age 18 or higher * healthy (self-reported) * women and men

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Comparison of two CO rebreathing protocols (aCO and oCO)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 bloodsamplingDuring 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.

Secondary

MeasureTime frameDescription
Reliability of aCO and oCODuring data collection (3 months)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.

Countries

Switzerland

Contacts

Primary ContactJon Wehrlin, Dr. scient., MSc.
jon.wehrlin@baspo.admin.ch+41 58 467 61 25
Backup ContactKatja Kellenberger, MSc
katja.kellenberger@baspo.admin.ch+41584661803

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026