Comparison of Noninvasive Hemoglobin Disposable Sensors

Masimo Corporation1 site in 1 country44 target enrollmentJuly 10, 2014

ConditionsHealthy

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Healthy
Sponsor: Masimo Corporation
Enrollment: 44
Locations: 1
Primary Endpoint: Accuracy of Noninvasive Sensors 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 two noninvasive hemoglobin sensors will be assessed by comparison to hemoglobin measurements from a laboratory analyzer.

Registry

clinicaltrials.gov

Start Date

July 10, 2014

End Date

July 25, 2014

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 for subjects under 6 feet tall.
•Physical status of ASA I of II
•Able to read and communicate in English
•Has signed written informed consent
•Female, non pregnant.

Exclusion Criteria

•Age less than 18 yrs and greater than 40 years
•If the Warming and cooling subjects have open cuts of skin abrasions on their extremities they will be excluded because alcohol spray may be painful.
•Weight of less than 110 lbs or more than 250 lbs if the subject is less than 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).

Outcomes

Primary Outcomes

Accuracy of Noninvasive Sensors 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. The accuracy results from both sensors will be assessed for equivalence