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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Sean McLean, MD, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT01750463
First received: December 5, 2012
Last updated: January 31, 2013
Last verified: January 2013
History of Changes
  Purpose

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.


Condition Intervention
Invasive vs Non Invasive Hemoglobin Results
 Other: Masimo Pronto Rad 7 Non-Invasive hemoglobin monitor
Other: Standard Laboratory Blood Draw and Hemoglobin Analysis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by NLM:

MedlinePlus related topics: Rashes
U.S. FDA Resources

Further study details as provided by University of North Carolina, Chapel Hill:

Primary Outcome Measures:
  • Comparison of standard hemoglobin monitoring vs. the MASIO non-invasive hemoglobin monitor [ Time Frame: up to 48 hours, post PICU admission ] [ Designated as safety issue: No ]

    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.



Estimated Enrollment: 30
Study Start Date: January 2013
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Arm A

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:
  • Masimo Pronto Rad 7 Non-Invasive hemoglobin monitor
  • Rainbow adhesive sonsor R1 20L
  • Rainbow reusable spot check sensor DCIP SC-200
  • Rainbow reusable spot check sensor DCI SC-200
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.
Other Name: Standard Laboratory Blood Draw and Hemoglobin Analysis

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.

  Eligibility

Ages Eligible for Study:   up to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

pediatric patients admitted to the PICU requiring hemoglobin monitoring

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01750463

Locations
United States, North Carolina
Pediatric Intensive Care Unit, University of North Carolina
Chapel Hill, North Carolina, United States, 27599
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Investigators
Principal Investigator: Michael Phillips, MD University of North Carolina,Chapel Hill, NC
  More Information

Additional Information:
Link to North Carolina Children's Hospital at UNC  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Sean McLean, MD, MD, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT01750463     History of Changes
Other Study ID Numbers: 12-2019
Study First Received: December 5, 2012
Last Updated: January 31, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of North Carolina, Chapel Hill:
Pediatric critically ill
Masimo
hemoglobin
 monitoring
UNC
PICU

Additional relevant MeSH terms:
Critical Illness
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on May 19, 2013