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

This study is currently recruiting participants.
Verified July 2012 by Hopital Foch
Sponsor:
Information provided by (Responsible Party):
Hopital Foch
ClinicalTrials.gov Identifier:
NCT01654913
First received: July 16, 2012
Last updated: July 30, 2012
Last verified: July 2012
History of Changes
  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:

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

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: July 2013
Estimated Primary Completion Date: July 2013 (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
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: July 30, 2012
Health Authority: France: Direction Générale de la Santé

Keywords provided by Hopital Foch:
hemoglobin determination
oxygen

ClinicalTrials.gov processed this record on May 19, 2013