Influence of Oxygen on Non-invasive Measurement of Hemoglobin

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

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Key information

Conditions

Anesthesia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hopital Lariboisière, Paris, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

hemoglobin measurement

Device

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).

Primary outcomes

influence of the inspired oxygen fraction on the noninvasive measurement of hemoglobin (Pronto 7 and NBM-200 devices)

Time frame: one year (end of the recrutement period)

Statistical comparison of the 3 measurements (baseline, FiO2 50%, FiO295%) for each device

Secondary outcomes

agreement between the noninvasive methods of measurement of hemoglobin and the laboratory analysis

Time frame: one year (end of the recrutement period)

Statistical comparison of the 2 devices

Sponsors and collaborators

Lead sponsor

Hopital Foch

Other

Registry information

Official study title

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

Acronym: Hb-O2

Important dates

Study start: 2012
Primary completion: 2014
Study completion: 2014
First posted: Aug 1, 2012
Registry last updated: Oct 31, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed