Hemoglobin MASIMO and Laboratory Measurement

This study has been completed.
Sponsor:
Information provided by:
Hopital Foch
ClinicalTrials.gov Identifier:
NCT00912379
First received: June 1, 2009
Last updated: April 19, 2010
Last verified: April 2010
  Purpose

The purpose of this study is to compare the hemoglobin results obtained with the Masimo SpHb™ 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™ 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 ]

Estimated 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
hemogobin determination
ICU and emergency unit patients
Biological: hemoglobin determination
laboratory and non invasive hemoglobin determinations

  Eligibility

Ages Eligible for Study:   18 Years and older
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

Criteria

Inclusion Criteria:

  • emergency unit patients, PACU and ICU 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: NCT00912379

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

No publications provided

Responsible Party: Pr Fischler, Hopital Foch
ClinicalTrials.gov Identifier: NCT00912379     History of Changes
Other Study ID Numbers: 2009/10
Study First Received: June 1, 2009
Last Updated: April 19, 2010
Health Authority: France: Direction Générale de la Santé

ClinicalTrials.gov processed this record on October 30, 2014