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Completed

NCT Number: NCT02930850

Spot-Check Noninvasive Hemoglobin (SpHb) Clinical Validation

The purpose study is to report on the accuracy of noninvasive hemoglobin (SpHb) as compared to hemoglobin measurements obtained from a laboratory hematology analyzer.

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Key information

Conditions

Anemia Healthy Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, Lymphoid Lymphatic Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Pediatric ALL Precursor Cell Lymphoblastic Leukemia-Lymphoma

Age range

1 month and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Site 4, Burbank, California, United States

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About this study

The primary objective of this clinical investigation is to report on the accuracy of the Rad-67 and DCI Mini sensor to measure SpHb as compared to hemoglobin measurements obtained from a manual HiCN analytical method and automated Beckman Coulter laboratory hematology analyzers.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Age: Greater than one month
  • Weight: Greater than or equal to 3kg
  • The subject or the subject's legally authorized representative has given written informed consent/assent to participate in the study

Exclusion criteria

  • Subjects with skin abnormalities at the planned application sites that may interfere with sensor application, per directions-for-use (DFU) or trans-illumination of the site, such as burns, scar tissue, nail polish, acrylic nails, infections, abnormalities, etc.
  • Subjects deemed not suitable for the study at the discretion of the investigator
  • Subjects unlikely to be able to refrain from excessive motion during data collection. Excessive motion includes postural changes, making hand gestures, involuntary muscular movements, etc.
  • Decision-impaired adult and pediatric subjects who are unable to give consent and assent

Treatment and study plan

Rad-67 Pulse oximeter

Device

Noninvasive pulse oximeter that measures hemoglobin

Primary outcomes

  1. Accuracy of hemoglobin measurement

    Time frame: Up to 2 hours per subject

    Accuracy willl be determined by comparing the noninvasive hemoglobin measurement of the pulse oximeter to the hemoglobin value obtained from a blood sample and calculating the arithmetic root mean square(Arms) error value.

Sponsors and collaborators

Lead sponsor

Masimo Corporation

Industry

Registry information

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Oct 12, 2016
Registry last updated
Apr 8, 2019

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.

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