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Hemoglobin Measured by MASIMO SpHb™ Device and Laboratory Measurement

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00912379
First Posted: June 3, 2009
Last Update Posted: September 26, 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 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 ]

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

  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
Sampling Method:   Probability Sample
Study Population
emergency unit patients and ICU patients requiring an hemoglobin determination
Criteria

Inclusion Criteria:

  • emergency unit patients, PACU (post-anaesthesia care unit) and ICU 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): NCT00912379


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

Responsible Party: Hopital Foch
ClinicalTrials.gov Identifier: NCT00912379     History of Changes
Other Study ID Numbers: 2009/10
First Submitted: June 1, 2009
First Posted: June 3, 2009
Last Update Posted: September 26, 2016
Last Verified: September 2016