Comparison of the Automatized and the Optimized Carbon Monoxid Rebreathing Protocol Determining Hemoglobinmass With Capillary and Venous Blood Sampling
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 31
- Locations
- 1
- Primary Endpoint
- Comparison of two CO rebreathing protocols (aCO and oCO)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •age 18 or higher
- •healthy (self-reported)
- •women and men
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Reliability of aCO and oCO(During data collection (3 months))