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NCT01321580 Clinical Trial

Hemoglobin MASIMO (Pronto 7) and Laboratory Measurement

Emergencies Clinical Trial

Official title:
Comparison of the Hemoglobin Results Obtained With the Masimo Pronto 7 and the Clinical Laboratory Measurement Study

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01321580
Other study ID # 2010/43
Secondary ID 2010-A00541-38
Status Completed
Phase N/A
First received March 19, 2011
Last updated November 2, 2016
Start date January 2011
Est. completion date February 2011

Study information
Verified date November 2016
Source Hopital Foch
Contact n/a
Is FDA regulated No
Health authority France: Direction Générale de la Santé
Study type Interventional

Clinical Trial Summary

The purpose of this study is to compare the hemoglobin results obtained with the Masimo Pronto 7 and the Clinical Laboratory.

Recruitment information / eligibility
Status Completed
Enrollment 300
Est. completion date February 2011
Est. primary completion date February 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- emergency unit patients requiring an hemoglobin determination

Exclusion Criteria:

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

Intervention

Device:
• Masimo Pronto 7
non invasive hemoglobin determination by the Masimo Pronto 7 versus laboratory hemoglobin measurement

Locations
Country Name City State
France Hôpital Foch Suresnes

Sponsors (1)
Lead Sponsor Collaborator
Hopital Foch

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary accuracy of Masimo Pronto 7 correlation, Bland and Altman analysis 6 months No
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