Hemoglobin MASIMO (Pronto 7) and Laboratory Measurement

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01321580
Recruitment Status : Completed
First Posted : March 23, 2011
Last Update Posted : November 3, 2016
Information provided by (Responsible Party):
Hopital Foch

Brief Summary:
The purpose of this study is to compare the hemoglobin results obtained with the Masimo Pronto 7 and the Clinical Laboratory.

Condition or disease Intervention/treatment Phase
Emergencies Device: Masimo Pronto 7 Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 300 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Comparison of the Hemoglobin Results Obtained With the Masimo Pronto 7 and the Clinical Laboratory Measurement Study
Study Start Date : January 2011
Actual Primary Completion Date : February 2011
Actual Study Completion Date : February 2011

Arm Intervention/treatment
Experimental: Group A Device: Masimo Pronto 7
non invasive hemoglobin determination by the Masimo Pronto 7 versus laboratory hemoglobin measurement

Primary Outcome Measures :
  1. accuracy of Masimo Pronto 7 [ Time Frame: 6 months ]
    correlation, Bland and Altman analysis

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

Inclusion Criteria:

  • emergency unit patients requiring an hemoglobin determination

Exclusion Criteria:

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 identifier (NCT number): NCT01321580

Hôpital Foch
Suresnes, France, 92150
Sponsors and Collaborators
Hopital Foch

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Hopital Foch Identifier: NCT01321580     History of Changes
Other Study ID Numbers: 2010/43
2010-A00541-38 ( Other Identifier: ANSM )
First Posted: March 23, 2011    Key Record Dates
Last Update Posted: November 3, 2016
Last Verified: November 2016

Additional relevant MeSH terms:
Disease Attributes
Pathologic Processes