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Hemoglobin Measured by MASIMO SpHb™ Device and Laboratory Measurement

This study has been completed.
Information provided by (Responsible Party):
Hopital Foch Identifier:
First received: June 1, 2009
Last updated: September 23, 2016
Last verified: September 2016
The purpose of this study is to compare the hemoglobin results obtained with the Masimo SpHb™ device and the Clinical Laboratory.

Condition Intervention
Patients' Assessment
Biological: hemoglobin determination

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Comparison of the Hemoglobin Results Obtained With the Masimo SpHb™ Device and the Clinical Laboratory Measurement

Further study details as provided by Hopital Foch:

Primary Outcome Measures:
  • Accuracy of the Masimo Labs Pulse-Hemoglobin-Meter Monitor [ Time Frame: End of the period of recruitment ] [ Designated as safety issue: No ]

Enrollment: 300
Study Start Date: June 2009
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
hemoglobin determination
ICU and emergency unit patients
Biological: hemoglobin determination
laboratory and non invasive hemoglobin determinations


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
emergency unit patients and ICU patients requiring an hemoglobin determination

Inclusion Criteria:

  • emergency unit patients, PACU (post-anaesthesia care unit) and ICU patients requiring an hemoglobin determination

Exclusion Criteria:

  Contacts and Locations
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Please refer to this study by its identifier: NCT00912379

Hôpital Foch
Suresnes, France, 92151
Sponsors and Collaborators
Hopital Foch
  More Information

Responsible Party: Hopital Foch Identifier: NCT00912379     History of Changes
Other Study ID Numbers: 2009/10 
Study First Received: June 1, 2009
Last Updated: September 23, 2016
Health Authority: France: Direction Générale de la Santé processed this record on October 21, 2016