Pediatric Intensive Care Unit, University of North Carolina
Chapel Hill, North Carolina, 27599, United States
NCT Number: NCT01750463
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.
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Notify Me30 day–18 year
All sexes
Observational
Chapel Hill, North Carolina, 27599, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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: Rainbow adhesive sonsor R1 20L, Rainbow reusable spot check sensor DCIP SC-200, Rainbow reusable spot check sensor DCI SC-200
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.
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.
University of North Carolina, Chapel Hill
Other
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
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.