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

Hemoglobin Results Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01750463
• Other study ID #: 12-2019
• Status: Completed
• Phase: N/A
• First received: December 5, 2012
• Last updated: December 1, 2014
• Start date: January 2013
• Est. completion date: May 2013

Study information

• Verified date: December 2014
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 18 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Critical Illness
• Hemoglobin Results

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Pediatric Intensive Care Unit, University of North Carolina	Chapel Hill	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of standard hemoglobin monitoring vs. the MASIO non-invasive hemoglobin monitor	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.	up to 48 hours, post PICU admission	No

External Links

•   Link to North Carolina Children's Hospital at UNC