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

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.

Study Overview

• Status: Unknown
• Conditions: Hemoglobins
• Intervention / Treatment: Device: Automatized carbonmonoxide rebreathing machine - OpCO Detalo instruments

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 Type: Interventional
• Enrollment (Anticipated): 31
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jon Wehrlin, Dr. scient., MSc.; Phone Number: +41 58 467 61 25; Email: jon.wehrlin@baspo.admin.ch
• Study Contact Backup: Name: Katja Kellenberger, MSc; Phone Number: +41584661803 +41584661803; Email: katja.kellenberger@baspo.admin.ch

Study Locations

• Switzerland
  • Magglingen, Switzerland
    • Recruiting
    • Swiss Federal Instistiution of Sport
    • Contact: Jon Wehrlin; Phone Number: +58 4676125; Email: jon.wehrlin@baspo.admin.ch
    • Contact: Katja Kellenberger; Phone Number: +41792782109; Email: katja.kellenberger@baspo.admin.ch
    • Principal Investigator: Jon Wehrlin, Dr.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Optimized carbonmonoxid rebreathing protocol (oCO); 2 min rebreathing period seated position capillary blood sampling	Device: Automatized 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.
ACTIVE_COMPARATOR: Automatized carbonmonoxide rebreathing protocol (aCO); 10 minutes rebreathing period supine position venous blood sampling	Device: Automatized 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of two CO rebreathing protocols (aCO and oCO)	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.	During data collection (3 months)
Comparison of capillary and venous bloodsampling	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.	During data collection (3 months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reliability of aCO and oCO	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.	During data collection (3 months)

Collaborators and Investigators

• Sponsor: Swiss Federal Institute of Sport Magglingen
• Investigators: Principal Investigator: Jon Wehrlin, Dr. scient., MSc., Swiss Federal Institute of Sport Magglingen

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 20, 2020
• Primary Completion (ANTICIPATED): April 20, 2020
• Study Completion (ANTICIPATED): August 1, 2020

Study Registration Dates

• First Submitted: December 3, 2019
• First Submitted That Met QC Criteria: December 3, 2019
• First Posted (ACTUAL): December 6, 2019

Study Record Updates

• Last Update Posted (ACTUAL): March 11, 2020
• Last Update Submitted That Met QC Criteria: March 9, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Antimetabolites; Gasotransmitters; Carbon Monoxide
• Other Study ID Numbers: COMP_aCO_oCO

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No