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Influence of Oxygen on Non-invasive Measurement of Hemoglobin

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01654913
Acronym
Hb-O2
Enrollment
47
Registered
2012-08-01
Start date
2012-07-31
Completion date
2014-11-30
Last updated
2016-10-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia

Keywords

hemoglobin determination, oxygen

Brief summary

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

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).

Sponsors

Hopital Foch
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
influence of the inspired oxygen fraction on the noninvasive measurement of hemoglobin (Pronto 7 and NBM-200 devices)one year (end of the recrutement period)Statistical comparison of the 3 measurements (baseline, FiO2 50%, FiO295%) for each device

Secondary

MeasureTime frameDescription
agreement between the noninvasive methods of measurement of hemoglobin and the laboratory analysisone year (end of the recrutement period)Statistical comparison of the 2 devices

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026