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

History of Changes

Tracking Information
First Received Date ^ICMJE	June 1, 2009
Last Updated Date	April 19, 2010
Start Date ^ICMJE	June 2009
Primary Completion Date	April 2010 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: June 2, 2009)	Accuracy of the Masimo Labs Pulse-Hemoglobin-Meter Monitor [ Time Frame: End of the period of recruitment ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00912379 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Hemoglobin MASIMO and Laboratory Measurement
Official Title ^ICMJE	Comparison of the Hemoglobin Results Obtained With the Masimo SpHb™ and the Clinical Laboratory Measurement
Brief Summary	The purpose of this study is to compare the hemoglobin results obtained with the Masimo SpHb™ and the Clinical Laboratory.
Detailed Description	Not Provided
Study Type ^ICMJE	Observational
Study Design ^ICMJE	Observational Model: Cohort Time Perspective: Prospective
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
Sampling Method	Probability Sample
Study Population	emergency unit patients and ICU patients requiring an hemoglobin determination
Condition ^ICMJE	Patients' Assessment
Intervention ^ICMJE	Biological: hemoglobin determination laboratory and non invasive hemoglobin determinations
Study Group/Cohort (s)	hemogobin determination ICU and emergency unit patients Intervention: Biological: hemoglobin determination
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Estimated Enrollment ^ICMJE	300
Completion Date	April 2010
Primary Completion Date	April 2010 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: emergency unit patients, PACU and ICU patients requiring an hemoglobin determination Exclusion Criteria: none
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	France

Administrative Information
NCT Number ^ICMJE	NCT00912379
Other Study ID Numbers ^ICMJE	2009/10
Has Data Monitoring Committee	No
Responsible Party	Pr Fischler, Hopital Foch
Study Sponsor ^ICMJE	Hopital Foch
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Hopital Foch
Verification Date	April 2010
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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