Accuracy of Noninvasive Hemoglobin Sensor (Rainbow Reusable DCI)

In this study, the accuracy of a noninvasive hemoglobin sensor(s) will be assessed by comparison to hemoglobin measurements from a laboratory hematology analyzer. Blood samples are collected from healthy volunteers who are enrolled in either a blood draw procedure or a hemodilution procedure wherein blood is repeatedly sampled as the concentration of hemoglobin is reduced in a controlled manner by administering fluids intravenously.

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Key information

Conditions

Healthy

Age range

18 year 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.

A. Hemodilution Test Procedure

Inclusion criteria

Weight of more than 110 lbs and less than 220 lbs.
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 35 years
Weight of less than 110 lbs or more than 220 lbs.
Hemoglobin less than 12 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.
Hypertension: Systolic BP >140 mmHg or Diastolic BP > 90 mmHg.
Baseline heart rate < 50 bpm.
Inability to tolerate sitting still or minimal movement for up to 90 minutes
Discretion of investigator

B. Blood Draw Test Procedure

Inclusion criteria

-Subjects must understand and consent to be in the study.

Exclusion criteria

Subjects less than 18 years of age.
Subjects who do not understand the study and the risks involved.
Anyone deemed ineligible by test personnel.

Treatment and study plan

Hemoglobin Sensor ((Rainbow Reusable DCI, DCIP))

Device

Measurement of Noninvasive Hemoglobin (SpHb)

Primary outcomes

Accuracy of Sensor by Arms Calculation

Time frame: 1-5 hours

Accuracy will 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: 2010
Primary completion: 2011
Study completion: 2011
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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Completed