Clinical trial NCT04189250: Comparison of the Automatized and the Optimized Carbon Monoxid Rebreathing Protocol
Official title: Comparison of the Automatized and the Optimized Carbon Monoxid Rebreathing Protocol Determining Hemoglobinmass With Capillary and Venous Blood Sampling
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hemoglobins
Lead sponsor: Swiss Federal Institute of Sport Magglingen
Sponsor class: OTHER_GOV
First posted: 2019-12-06
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Comparison of two CO rebreathing protocols (aCO and oCO)
timeFrame: During data collection (3 months)
measure: Comparison of capillary and venous bloodsampling
timeFrame: During data collection (3 months)
Secondary outcomes:
measure: Reliability of aCO and oCO
timeFrame: During data collection (3 months)
Other outcomes:
Locations:
city: Magglingen
country: Switzerland
facility: Swiss Federal Instistiution of Sport
Study officials:
affiliation: Swiss Federal Institute of Sport Magglingen
name: Jon Wehrlin, Dr. scient., MSc.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Fagoni 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.
citation: Siebenmann 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.
citation: Steiner 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.