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临床试验/NCT04189250
NCT04189250Unknown不适用

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

Swiss Federal Institute of Sport Magglingen1 个研究点 分布在 1 个国家目标入组 31 人开始时间: 2020年1月20日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
31
试验地点
1
主要终点
Comparison of two CO rebreathing protocols (aCO and oCO)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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

结局指标

主要结局

Comparison of two CO rebreathing protocols (aCO and oCO)

时间窗: 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

时间窗: 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.

次要结局

  • Reliability of aCO and oCO(During data collection (3 months))

研究者

发起方
Swiss Federal Institute of Sport Magglingen
申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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