Hemoglobin MASIMO (Pronto 7) and Laboratory Measurement

This study has been completed.
Sponsor:
Information provided by:
Hopital Foch
ClinicalTrials.gov Identifier:
NCT01321580
First received: March 19, 2011
Last updated: June 4, 2011
Last verified: June 2011
  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: 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 ] [ Designated as safety issue: No ]
    correlation, Bland and Altman analysis


Estimated 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)
Intervention Details:
    Device: Masimo Pronto 7
    non invasive hemoglobin determination by the Masimo Pronto 7 versus laboratory hemoglobin measurement
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • emergency unit patients requiring an hemoglobin determination

Exclusion Criteria:

  • none
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01321580

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

No publications provided by Hopital Foch

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Pr Fischler, Hopital Foch
ClinicalTrials.gov Identifier: NCT01321580     History of Changes
Other Study ID Numbers: 2010-43
Study First Received: March 19, 2011
Last Updated: June 4, 2011
Health Authority: France: Direction Générale de la Santé

Additional relevant MeSH terms:
Emergencies
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on July 31, 2014