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Hemoglobin MASIMO (Pronto 7) and Laboratory Measurement

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ClinicalTrials.gov Identifier: NCT01321580
Recruitment Status : Completed
First Posted : March 23, 2011
Last Update Posted : November 3, 2016
Sponsor:
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
Criteria

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 ClinicalTrials.gov identifier (NCT number): NCT01321580


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hopital Foch
ClinicalTrials.gov 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:
Emergencies
Disease Attributes
Pathologic Processes