Back to resultsHemoglobin MASIMO (Pronto 7) and Laboratory Measurement
Primary Purpose
Emergencies
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Masimo Pronto 7
Sponsored by
About this trial
This is an interventional diagnostic trial for Emergencies
Eligibility Criteria
Inclusion Criteria:
- emergency unit patients requiring an hemoglobin determination
Exclusion Criteria:
- none
Sites / Locations
- Hôpital Foch
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Group A
Arm Description
Outcomes
Primary Outcome Measures
accuracy of Masimo Pronto 7
correlation, Bland and Altman analysis
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01321580
Brief Title
Hemoglobin MASIMO (Pronto 7) and Laboratory Measurement
Official Title
Comparison of the Hemoglobin Results Obtained With the Masimo Pronto 7 and the Clinical Laboratory Measurement Study
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
February 2011 (Actual)
Study Completion Date
February 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hopital Foch
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to compare the hemoglobin results obtained with the Masimo Pronto 7 and the Clinical Laboratory.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Emergencies
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
300 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group A
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Masimo Pronto 7
Intervention Description
non invasive hemoglobin determination by the Masimo Pronto 7 versus laboratory hemoglobin measurement
Primary Outcome Measure Information:
Title
accuracy of Masimo Pronto 7
Description
correlation, Bland and Altman analysis
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
emergency unit patients requiring an hemoglobin determination
Exclusion Criteria:
none
Facility Information:
Facility Name
Hôpital Foch
City
Suresnes
ZIP/Postal Code
92150
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
22238693
Citation
Gayat E, Aulagnier J, Matthieu E, Boisson M, Fischler M. Non-invasive measurement of hemoglobin: assessment of two different point-of-care technologies. PLoS One. 2012;7(1):e30065. doi: 10.1371/journal.pone.0030065. Epub 2012 Jan 6.
Results Reference
derived
Learn more about this trial
Hemoglobin MASIMO (Pronto 7) and Laboratory Measurement
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