Comparison of the Automatized and the Optimized Carbon Monoxid Rebreathing Protocol
1 other identifier
interventional
31
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2020
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 3, 2019
CompletedFirst Posted
Study publicly available on registry
December 6, 2019
CompletedStudy Start
First participant enrolled
January 20, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 20, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2020
CompletedMarch 11, 2020
March 1, 2020
3 months
December 3, 2019
March 9, 2020
Conditions
Outcome Measures
Primary Outcomes (2)
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 Outcomes (1)
Reliability of aCO and oCO
During data collection (3 months)
Study Arms (2)
Optimized carbonmonoxid rebreathing protocol (oCO)
PLACEBO COMPARATOR2 min rebreathing period seated position capillary blood sampling
Automatized carbonmonoxide rebreathing protocol (aCO)
ACTIVE COMPARATOR10 minutes rebreathing period supine position venous blood sampling
Interventions
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.
Eligibility Criteria
You may qualify if:
- age 18 or higher
- healthy (self-reported)
- women and men
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Swiss Federal Instistiution of Sport
Magglingen, Switzerland
Related Publications (4)
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.
PMID: 16222540BACKGROUNDFagoni 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.
PMID: 28135764BACKGROUNDSiebenmann 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.
PMID: 28663373BACKGROUNDSteiner 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.
PMID: 21091271BACKGROUND
Study Officials
- PRINCIPAL INVESTIGATOR
Jon Wehrlin, Dr. scient., MSc.
Swiss Federal Institute of Sport Magglingen
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 3, 2019
First Posted
December 6, 2019
Study Start
January 20, 2020
Primary Completion
April 20, 2020
Study Completion
August 1, 2020
Last Updated
March 11, 2020
Record last verified: 2020-03
Data Sharing
- IPD Sharing
- Will not share