Influence of Oxygen on Non-invasive Measurement of Hemoglobin
Hb-O2
Influence of the Inspired Oxygen Fraction on the Noninvasive Measurement of Hemoglobin Using Two Different Devices (Namely Pronto 7 and NBM-200)
2 other identifiers
interventional
47
1 country
2
Brief Summary
This study examines the effect of oxygen supplementation on the non-invasive measurement of 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 Jul 2012
Typical duration for not_applicable
2 active sites
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
Study Start
First participant enrolled
July 1, 2012
CompletedFirst Submitted
Initial submission to the registry
July 16, 2012
CompletedFirst Posted
Study publicly available on registry
August 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2014
CompletedOctober 31, 2016
October 1, 2016
2.3 years
July 16, 2012
October 28, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
influence of the inspired oxygen fraction on the noninvasive measurement of hemoglobin (Pronto 7 and NBM-200 devices)
Statistical comparison of the 3 measurements (baseline, FiO2 50%, FiO295%) for each device
one year (end of the recrutement period)
Secondary Outcomes (1)
agreement between the noninvasive methods of measurement of hemoglobin and the laboratory analysis
one year (end of the recrutement period)
Study Arms (1)
surgical patients
EXPERIMENTALpatients studied just before induction of anesthesia
Interventions
Non invasive hemoglobin measurements (Pronto 7 device and NBM-200 device)will be made with : * at baseline (simultaneous blood sample for a laboratory measurement of hemoglobin), * with the patient breathing oxygen via a face-mask (FiO2 50 ± 5%), * with the patient breathing oxygen via a face-mask (FiO2 90 ± 5%) (simultaneous blood sample for a laboratory measurement of hemoglobin).
Eligibility Criteria
You may qualify if:
- adult patients scheduled for a potentially hemorrhagic surgical procedure
You may not qualify if:
- anomaly (malformation, infection, swelling, irritation, ulceration, degenerative changes or significant edema) of the fingers,
- tremors.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hopital Fochlead
Study Sites (2)
Hopital Lariboisière
Paris, 75010, France
Hopital Foch
Suresnes, 92151, France
Related Publications (3)
Gayat E, Aulagnier J, Matthieu E, Boisson M, Fischler M. Non-invasive measurement of hemoglobin: assessment of two different point-of-care technologies. PLoS One. 2012;7(1):e30065. doi: 10.1371/journal.pone.0030065. Epub 2012 Jan 6.
PMID: 22238693BACKGROUNDGayat E, Bodin A, Fischler M. Instability in non-invasive haemoglobin measurement: a possible influence of oxygen administration. Acta Anaesthesiol Scand. 2011 Aug;55(7):902. doi: 10.1111/j.1399-6576.2011.02469.x. Epub 2011 Jun 9. No abstract available.
PMID: 21658016BACKGROUNDGayat E, Imbert N, Roujansky A, Lemasle L, Fischler M. Influence of Fraction of Inspired Oxygen on Noninvasive Hemoglobin Measurement: Parallel Assessment of 2 Monitors. Anesth Analg. 2017 Jun;124(6):1820-1823. doi: 10.1213/ANE.0000000000001783.
PMID: 28221201DERIVED
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 16, 2012
First Posted
August 1, 2012
Study Start
July 1, 2012
Primary Completion
November 1, 2014
Study Completion
November 1, 2014
Last Updated
October 31, 2016
Record last verified: 2016-10