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Completed

NCT Number: NCT01750463

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

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.

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Key information

Conditions

Age range

30 day–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Pediatric Intensive Care Unit, University of North Carolina

Chapel Hill, North Carolina, 27599, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Masimo Pronto Rad 7 Non-Invasive hemoglobin monitor

Other

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: Rainbow adhesive sonsor R1 20L, Rainbow reusable spot check sensor DCIP SC-200, Rainbow reusable spot check sensor DCI SC-200

Standard Laboratory Blood Draw and Hemoglobin Analysis

Other

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.

Primary outcomes

  1. Comparison of standard hemoglobin monitoring vs. the MASIO non-invasive hemoglobin monitor

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Dec 17, 2012
Registry last updated
Dec 3, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.