Influence of Oxygen on Non-invasive Measurement of Hemoglobin

NCT ID: NCT01654913

Last Updated: 2016-10-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

47 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-31

Study Completion Date

2014-11-30

Brief Summary

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

Detailed Description

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Conditions

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Anesthesia

Keywords

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hemoglobin determination oxygen

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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surgical patients

patients studied just before induction of anesthesia

Group Type EXPERIMENTAL

hemoglobin measurement

Intervention Type 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).

Interventions

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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).

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hopital Foch

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hopital Lariboisière

Paris, , France

Site Status

Hopital Foch

Suresnes, , France

Site Status

Countries

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France

References

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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.

Reference Type BACKGROUND
PMID: 22238693 (View on PubMed)

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. No abstract available.

Reference Type BACKGROUND
PMID: 21658016 (View on PubMed)

Gayat 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.

Reference Type DERIVED
PMID: 28221201 (View on PubMed)

Other Identifiers

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2012-A00416-37

Identifier Type: OTHER

Identifier Source: secondary_id

2012/16

Identifier Type: -

Identifier Source: org_study_id