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

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ClinicalTrials.gov Identifier: NCT01654913
Recruitment Status : Completed
First Posted : August 1, 2012
Last Update Posted : October 31, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
This study examines the effect of oxygen supplementation on the non-invasive measurement of hemoglobin.

Condition or disease Intervention/treatment
Anesthesia Device: hemoglobin measurement

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 47 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Influence of the Inspired Oxygen Fraction on the Noninvasive Measurement of Hemoglobin Using Two Different Devices (Namely Pronto 7 and NBM-200)
Study Start Date : July 2012
Primary Completion Date : November 2014
Study Completion Date : November 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oxygen Therapy
U.S. FDA Resources

Arms and Interventions

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).


Outcome Measures

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01654913


Locations
France
Hopital Lariboisière
Paris, France, 75010
Hopital Foch
Suresnes, France, 92151
Sponsors and Collaborators
Hopital Foch