NCT01321580

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2011

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 19, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 23, 2011

Completed
Last Updated

November 3, 2016

Status Verified

November 1, 2016

Enrollment Period

1 month

First QC Date

March 19, 2011

Last Update Submit

November 2, 2016

Conditions

Emergencies

Outcome Measures

Primary Outcomes (1)

  • accuracy of Masimo Pronto 7

    correlation, Bland and Altman analysis

    6 months

Study Arms (1)

Group A

EXPERIMENTAL
Device: Masimo Pronto 7

Interventions

Masimo Pronto 7DEVICE

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

Group A

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • emergency unit patients requiring an hemoglobin determination

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Foch

Suresnes, 92150, France

Location

Related Publications (1)

  • 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.

    PMID: 22238693DERIVED

MeSH Terms

Conditions

Emergencies

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 19, 2011

First Posted

March 23, 2011

Study Start

January 1, 2011

Primary Completion

February 1, 2011

Study Completion

February 1, 2011

Last Updated

November 3, 2016

Record last verified: 2016-11

Locations

FR(1)