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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by Hopital Foch
Sponsor:
Information provided by (Responsible Party):
Hopital Foch
ClinicalTrials.gov Identifier:
NCT01654913
First received: July 16, 2012
Last updated: December 5, 2013
Last verified: December 2013
  Purpose

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


Condition Intervention
Anesthesia
Device: hemoglobin measurement

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: 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)

Resource links provided by NLM:


Further study details as provided by Hopital Foch:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
    Statistical comparison of the 3 measurements (baseline, FiO2 50%, FiO295%) for each device


Secondary Outcome Measures:
  • agreement between the noninvasive methods of measurement of hemoglobin and the laboratory analysis [ Time Frame: one year (end of the recrutement period) ] [ Designated as safety issue: No ]
    Statistical comparison of the 2 devices


Estimated Enrollment: 50
Study Start Date: July 2012
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01654913

Contacts
Contact: Marc Fischler, MD 46252442 ext 00331 m.fischler@hopital-foch.org

Locations
France
Hopital Lariboisière Recruiting
Paris, France, 75010
Contact: Etienne Gayat, MD         
Hopital Foch Recruiting
Suresnes, France, 92151
Contact: Marc Fischler, MD    46252442 ext 00331    m.fischler@hopital-foch.org   
Principal Investigator: Marc Fischler, MD         
Sponsors and Collaborators
Hopital Foch
  More Information

Publications:
Responsible Party: Hopital Foch
ClinicalTrials.gov Identifier: NCT01654913     History of Changes
Other Study ID Numbers: 2012/16
Study First Received: July 16, 2012
Last Updated: December 5, 2013
Health Authority: France: Direction Générale de la Santé

Keywords provided by Hopital Foch:
hemoglobin determination
oxygen

ClinicalTrials.gov processed this record on September 16, 2014