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Comparison of the Automatized and the Optimized Carbon Monoxid Rebreathing Protocol

S

Swiss Federal Institute of Sport Magglingen

Status

Unknown

Conditions

Hemoglobins

Treatments

Device: Automatized carbonmonoxide rebreathing machine - OpCO Detalo instruments

Study type

Interventional

Funder types

Other

Identifiers

NCT04189250
COMP_aCO_oCO

Details and patient eligibility

About

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.

Full 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.

Enrollment

31 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

31 participants in 2 patient groups, including a placebo group

Optimized carbonmonoxid rebreathing protocol (oCO)
Placebo Comparator group
Description:
2 min rebreathing period seated position capillary blood sampling
Treatment:
Device: Automatized carbonmonoxide rebreathing machine - OpCO Detalo instruments
Automatized carbonmonoxide rebreathing protocol (aCO)
Active Comparator group
Description:
10 minutes rebreathing period supine position venous blood sampling
Treatment:
Device: Automatized carbonmonoxide rebreathing machine - OpCO Detalo instruments

Trial contacts and locations

1

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Central trial contact

Jon Wehrlin, Dr. scient., MSc.; Katja Kellenberger, MSc

Data sourced from clinicaltrials.gov

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