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Completed

NCT Number: NCT03128853

Spot-Check Noninvasive Hemoglobin (SpHb) Repeatability and Reproducibility

Single-arm study to investigate the repeatability and reproducibility of SpHb measurements from the Rad-67 and DCI Mini sensor.

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Key information

Conditions

Anemia Healthy Hematologic Diseases Hemic and Lymphatic Diseases

Age range

1 month and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Masimo Clinical Laboratory, Irvine, California, United States

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About this study

This study aims to evaluate the repeatability and reproducibility of Masimo's pulse CO-Oximeter and sensor to determine the device and sensor's precision in SpHb measurements.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

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

Exclusion criteria

  • Decision-impaired adult and pediatric patients who are unable to give informed consent/assent
  • Decision-impaired adult on behalf of a pediatric patient who is unable to assent
  • 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.

Treatment and study plan

Rad-67 and DCI Mini Sensor

Device

Primary outcomes

  1. Repeatability and reproducibility of CO-oximeter and sensor

    Time frame: 120 minutes

    The Repeatability and Reproducibility of the sensor will be assessed by varying the testing conditions (operator/device, finger, subject, and repetition) to determine the device and sensor's precision in SpHb measurements.

Sponsors and collaborators

Lead sponsor

Masimo Corporation

Industry

Registry information

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Apr 25, 2017
Registry last updated
Apr 27, 2020

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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