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NCT01654913 Clinical Trial

Influence of Oxygen on Non-invasive Measurement of Hemoglobin

Anesthesia Clinical Trial

— Hb-O2  

Official title:
Influence of the Inspired Oxygen Fraction on the Noninvasive Measurement of Hemoglobin Using Two Different Devices (Namely Pronto 7 and NBM-200)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01654913
Other study ID # 2012/16
Secondary ID 2012-A00416-37
Status Completed
Phase N/A
First received July 16, 2012
Last updated October 28, 2016
Start date July 2012
Est. completion date November 2014

Study information
Verified date October 2016
Source Hopital Foch
Contact n/a
Is FDA regulated No
Health authority France: Direction Générale de la Santé
Study type Interventional

Clinical Trial Summary

This study examines the effect of oxygen supplementation on the non-invasive measurement of hemoglobin.

Recruitment information / eligibility
Status Completed
Enrollment 47
Est. completion date November 2014
Est. primary completion date November 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- adult patients scheduled for a potentially hemorrhagic surgical procedure

Exclusion Criteria:

- anomaly (malformation, infection, swelling, irritation, ulceration, degenerative changes or significant edema) of the fingers,

- tremors.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

Intervention

Device:
• hemoglobin measurement
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).

Locations
Country Name City State
France Hopital Lariboisière Paris
France Hopital Foch Suresnes

Sponsors (1)
Lead Sponsor Collaborator
Hopital Foch

Country where clinical trial is conducted

France, 

References & Publications (2)

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. — View Citation

Gayat 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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary 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) No
Secondary agreement between the noninvasive methods of measurement of hemoglobin and the laboratory analysis Statistical comparison of the 2 devices one year (end of the recrutement period) No
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