Hemoglobin Results
Conditions
Keywords
Pediatric critically ill, Masimo, hemoglobin, monitoring, UNC, PICU
Brief summary
This is a prospective study to determine the accuracy of the Masimo Pronto Non-Invasive Hemoglobin Monitor and associated Rainbow® probes in the detection of hemoglobin concentration in critically ill children.
Detailed description
This is a prospective study to determine the accuracy of the Masimo Pronto Non-Invasive Hemoglobin Monitor and associated Rainbow® probes in the detection of hemoglobin concentration in critically ill children. Data from at least 30 patients admitted to the Pediatric Intensive Care Unit (PICU) over a period of 2 months will be collected and analyzed for this study. Note, that this device would not lead to deviations in routine patient care; specifically, the non-invasive monitor placed on the patient's finger is FDA approved. The proposed monitors are identical macroscopically to monitors, which are currently used to measure oxygen saturation at this institution. Clinical decisions, additional blood draws or alterations to the plan of care will not be made based on study data. The objective is to compare the validity of the hemoglobin values determined from non-invasive technology with measured laboratory values for hemoglobin utilized as standard of care.
Interventions
OTHERMasimo Pronto Rad 7 Non-Invasive hemoglobin monitor
Patients admitted to PICU requiring hemoglobin monitoring will have a total hemoglobin (SpHb) assessment from Masimo non-invasive monitor, prior to standard, required blood draw and laboratory analysis.
OTHERStandard Laboratory Blood Draw and Hemoglobin Analysis
Patients admitted to PICU requiring hemoglobin monitoring will have a reading from Masimo non-invasive monitor, prior to standard, required blood draw and laboratory analysis.
Sponsors
University of North Carolina, Chapel Hill
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
30 Days to 18 Years
Healthy volunteers
No
Inclusion criteria
* Patient has been admitted to Pediatric Intensive Care Unit * Patient age is ≥ 30 days old and ≤ 18 years old * Patient weight ≥ 3 Kg. * Patient requires hemoglobin monitoring
Exclusion criteria
* Patient does not have exposed fingers/toes,due to congenital anomalies wound dressing or injury. * Patient weight is less than 3 Kg * Patient is less than 30 days old
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of standard hemoglobin monitoring vs. the MASIO non-invasive hemoglobin monitor | up to 48 hours, post PICU admission | We will obtain measurements using the Masimo Pronto device prior to the standard lab draw at the following time points: post admission to PICU, 12-48 hours. We will then perform analysis using Bland Altman methods to determine the degree of agreement. Data analysis will occur 1 year after enrollment completion. |
Countries
United States
Outcome results
None listed