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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):

Study Description
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
Emergencies Device: Masimo Pronto 7

Study Design

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
Primary Completion Date : February 2011
Study Completion Date : February 2011
Arms and Interventions

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


Outcome Measures

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


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:

  • emergency unit patients requiring an hemoglobin determination

Exclusion Criteria:

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): NCT01321580


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

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