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

Masimo Corporation1 site in 1 country132 target enrollmentDecember 27, 2011

ConditionsHealthy

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Healthy
Sponsor: Masimo Corporation
Enrollment: 132
Locations: 1
Primary Endpoint: Accuracy of Sensor by Arms Calculation
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

December 27, 2011

End Date

April 3, 2012

Last Updated

8 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Masimo Corporation

Responsible Party

Sponsor

Eligibility Criteria

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.
•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.

Outcomes

Primary Outcomes

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.