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Hemoglobin MASIMO (Pronto 7) and Laboratory Measurement

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01321580
First Posted: March 23, 2011
Last Update Posted: November 3, 2016
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.
Information provided by (Responsible Party):
Hopital Foch
  Purpose
The purpose of this study is to compare the hemoglobin results obtained with the Masimo Pronto 7 and the Clinical Laboratory.

Condition Intervention
Emergencies Device: Masimo Pronto 7

Study Type: Interventional
Study Design: 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

Further study details as provided by Hopital Foch:

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


Enrollment: 300
Study Start Date: January 2011
Study Completion Date: February 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group A Device: Masimo Pronto 7
non invasive hemoglobin determination by the Masimo Pronto 7 versus laboratory hemoglobin measurement

  Eligibility

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 Submitted: March 19, 2011
First Posted: March 23, 2011
Last Update Posted: November 3, 2016
Last Verified: November 2016

Additional relevant MeSH terms:
Emergencies
Disease Attributes
Pathologic Processes