Comparing Validity of Non-Invasive Hemoglobin Monitoring to Laboratory Results in Critically Ill Children

Completed

• Conditions: Hemoglobin Results
• Interventions: Other: Masimo Pronto Rad 7 Non-Invasive hemoglobin monitor; Other: Standard Laboratory Blood Draw and Hemoglobin Analysis

• Registration Number: NCT01750463
• Lead Sponsor: University of North Carolina, Chapel Hill

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.

Study Timeline

• Study First Submitted: 2012-12-05
• Study First Submitted QC: 2012-12-12
• Study First Posted: 2012-12-17
• Study Start: 2013-01
• Primary Completion: 2013-05
• Study Completion: 2013-05
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-01
• Last Update Posted: 2014-12-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 65

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Arm A	Masimo Pronto Rad 7 Non-Invasive hemoglobin monitor	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.
Arm A	Standard Laboratory Blood Draw and Hemoglobin Analysis	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.

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Pediatric Intensive Care Unit, University of North Carolina; 🇺🇸 Chapel Hill, North Carolina, United States