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

Study 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.

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Device: Rainbow Resposable Adhesive Sensors


Participation Criteria
=================
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. 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rainbow Resposable Adhesive Sensors<br>All subjects are enrolled into the test group and all subjects received the Rainbow Resposable Adhesive Sensors. | Device: Rainbow Resposable Adhesive Sensors<br>* Noninvasive Measurement of SpHb<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy of Sensor by Arms Calculation | 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. | 1-5 hours |