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OpenTrials
Completed

NCT Number: NCT02782806

Spot-Check Noninvasive Pulse CO-Oximeter Validation

In this study, the accuracy of a noninvasive hemoglobin sensor(s) will be assessed by comparison to hemoglobin measurements from a laboratory analyzer.

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Key information

Conditions

Anemia 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 Corporation

Irvine, California, 92618, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Male or female
  • Age: Greater than one month
  • Weight: Greater than or equal to 3kg
  • Any racial or ethnic group
  • The subject or the subject's legally authorized representative has given written informed consent/assent to participate in the study
  • If an ICU patient, total hemoglobin of < 9 g/dL at time of screening.

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.

Treatment and study plan

Masimo Rad-67 Pulse Oximeter

Device

Noninvasive pulse oximeter

Primary outcomes

  1. Accuracy of sensor

    Time frame: Up to 1 hr 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

Official study title

Spot-Check Noninvasive Hemoglobin (SpHb) Clinical Validation

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
May 25, 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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