Comparing Validity of Non-Invasive Hemoglobin Monitoring to Laboratory Results in Critically Ill Children
NCT ID: NCT01750463
Last Updated: 2014-12-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
65 participants
OBSERVATIONAL
2013-01-31
2013-05-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patient age is ≥ 30 days old and ≤ 18 years old
* Patient weight ≥ 3 Kg.
* Patient requires hemoglobin monitoring
Exclusion Criteria
* Patient weight is less than 3 Kg
* Patient is less than 30 days old
30 Days
18 Years
ALL
No
Sponsors
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University of North Carolina, Chapel Hill
OTHER
Responsible Party
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Sean McLean, MD
MD
Principal Investigators
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Michael Phillips, MD
Role: PRINCIPAL_INVESTIGATOR
University of North Carolina,Chapel Hill, NC
Locations
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Pediatric Intensive Care Unit, University of North Carolina
Chapel Hill, North Carolina, United States
Countries
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Other Identifiers
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12-2019
Identifier Type: -
Identifier Source: org_study_id