Evaluation of the Accuracy and Precision of the Masimo Labs Pulse-Hemoglobin-Meter Monitor in Surgical Patients
1 other identifier
observational
40
1 country
1
Brief Summary
The Masimo monitor can measure hemoglobin level noninvasively and accuratly
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Sep 2008
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2008
CompletedFirst Submitted
Initial submission to the registry
September 26, 2008
CompletedFirst Posted
Study publicly available on registry
September 30, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2011
CompletedMarch 29, 2021
March 1, 2021
3 months
September 26, 2008
March 24, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
corrlation of up to +/-0.1 gr% of the blood analysis to the monitor reading
1 year
Study Arms (1)
Adult patient undergoing a surgery
Adult patient undergoing a surgery in the supine position and require an arterial line for anesthesia/surgery purposes
Interventions
drawing a blood sample less that 0.5 mL each time, for around 10-12 times along the surgery (depends on surgical time)
Eligibility Criteria
Adult patients in UCI Medical Center undergoing surgery
You may qualify if:
- Adult having surgery with arterial line
You may not qualify if:
- Upper extremities surgery
- Pregnant women
- Children
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of California, Irvinelead
- Masimo Labscollaborator
Study Sites (1)
Univeristy of California Irvine Medical Center
Orange, California, 92868, United States
Biospecimen
Blood sample for the measurement of Hct, and ABG
Study Officials
- PRINCIPAL INVESTIGATOR
Abraham Rosenbaum, MD
University of California, Irvine
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 26, 2008
First Posted
September 30, 2008
Study Start
September 1, 2008
Primary Completion
December 1, 2008
Study Completion
December 1, 2011
Last Updated
March 29, 2021
Record last verified: 2021-03