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

University of North Carolina (UNC)

Status: Completed

Conditions: Hemoglobin Results

Treatments: Other: Standard Laboratory Blood Draw and Hemoglobin Analysis; Other: Masimo Pronto Rad 7 Non-Invasive hemoglobin monitor

Study type: Observational

Funder types: Other

Identifiers

NCT01750463

12-2019

Details and patient eligibility

About

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.

Full 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.

Enrollment: 65 patients

Sex: All

Ages: 30 days to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

65 participants in 1 patient group

Arm A

Description:

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.

Treatment:

Other: Standard Laboratory Blood Draw and Hemoglobin Analysis

Other: Masimo Pronto Rad 7 Non-Invasive hemoglobin monitor