Influence of Oxygen on Non-invasive Measurement of Hemoglobin (Hb-O2)

October 28, 2016 updated by: Hopital Foch

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

47

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75010
        • Hopital Lariboisiere
      • Suresnes, France, 92151
        • Hopital Foch

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: surgical patients
patients studied just before induction of anesthesia
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
one year (end of the recrutement period)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
one year (end of the recrutement period)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hopital Foch

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2012

Primary Completion (ACTUAL)

November 1, 2014

Study Completion (ACTUAL)

November 1, 2014

Study Registration Dates

First Submitted

July 16, 2012

First Submitted That Met QC Criteria

July 30, 2012

First Posted (ESTIMATE)

August 1, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

October 31, 2016

Last Update Submitted That Met QC Criteria

October 28, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012/16
  • 2012-A00416-37 (OTHER: ANSM)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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