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OpenTrials
Completed

NCT Number: NCT03124771

Accuracy of Noninvasive Hemoglobin Pulse Oximeter (Rainbow Resposable Adhesive Sensors)

In this study, the concentration of hemoglobin within the subject's blood will be reduced in a controlled manner by administering fluids intravenously. 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

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Masimo

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
  • 18-40 years of age
  • Weight of at least 110 lbs and less than 250 lbs or a BMI under 36 for subjects taller than 6 feet.
  • Physical status of ASA I of II
  • Able to read and communicate in English
  • Has signed written informed consent
  • Female, non pregnant. Female subjects will be provided with a pregnancy test free of charge.

Exclusion criteria

  • Age less than 18 yrs and greater than 40 years
  • Weight of less than 110 lbs or more than 250 lbs. or a BMI of 36 or greater for people over 6 feet tall.
  • Hemoglobin less than 11 g/dL
  • ASA physical status of III. IV, V.
  • Pregnant
  • Subject has known drug or alcohol abuse
  • Subject has skin abnormalities affecting the digits such as psoriasis, eczema, angioma, scar tissue, burn, fungal infection, substantial skin breakdown, nail polish or acrylic nails.
  • Subject has experienced a head injury with loss of consciousness within the last year.
  • Subject has known neurological and psychiatric disorder that interferes with the subjects' level of consciousness.
  • Known or concurrent chronic usage of psychoactive or anticonvulsive drugs within the last 90 days, or any use in the last 7 day (i.e. tricyclic antidepressants, MAO inhibitors, Lithum, neuroleptics, anxiolytics or antipsychotics, except SSRIs).
  • Subject has any medical condition which in the judgment of the investigator, renders them inappropriate for participation in this study, such as Reynauds Syndrome.
  • Systolic BP >140 mmHg or Diastolic BP > 100 mmHg.
  • Baseline heart rate < 50 bpm.
  • Inability to tolerate sitting still or minimal movement for up to 90 minutes
  • Discretion of investigator

Treatment and study plan

Rainbow Resposable Adhesive Sensors

Device

Noninvasive Measurement of SpHb

Primary outcomes

  1. Accuracy of Sensor by Arms Calculation

    Time frame: 1-5 hours

    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
2011
Primary completion
2012
Study completion
2012
First posted
Apr 24, 2017
Registry last updated
Jul 27, 2017

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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