Comparing Validity of Non-Invasive Hemoglobin Monitoring to Laboratory Results in Critically Ill Children
|ClinicalTrials.gov Identifier: NCT01750463|
Recruitment Status : Completed
First Posted : December 17, 2012
Last Update Posted : December 3, 2014
|Condition or disease||Intervention/treatment|
|Hemoglobin Results||Other: Masimo Pronto Rad 7 Non-Invasive hemoglobin monitor Other: Standard Laboratory Blood Draw and Hemoglobin Analysis|
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.
|Study Type :||Observational|
|Actual Enrollment :||65 participants|
|Official Title:||Verifying the Accuracy of the Masimo Pronto Non-Invasive Hemoglobin (Hb) Monitor and Associated Rainbow Probes Compared to Measured Laboratory Values in Critically Ill Pediatric Patients|
|Study Start Date :||January 2013|
|Primary Completion Date :||May 2013|
|Study Completion Date :||May 2013|
Critically ill pediatric patients admitted to PICU requiring hemoglobin monitoring.
Patients admitted to PICU requiring hemoglobin monitoring will have a reading total hemoglobin (SpHb) assessment done with the Masimo Pronto Rad 7 Non-Invasive hemoglobin monitor,prior to standard laboratory blood draw and hemoglobin analysis.
Other: Masimo 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.
Other Names:Other: Standard 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.
- Comparison of standard hemoglobin monitoring vs. the MASIO non-invasive hemoglobin monitor [ Time Frame: 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01750463
|United States, North Carolina|
|Pediatric Intensive Care Unit, University of North Carolina|
|Chapel Hill, North Carolina, United States, 27599|
|Principal Investigator:||Michael Phillips, MD||University of North Carolina,Chapel Hill, NC|