Comparison of Noninvasive Hemoglobin Disposable Sensors

Study Overview
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Brief Summary
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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.

Conditions
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Healthy

Intervention / Treatment
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* Device: Rainbow adhesive adult/pediatric sensor
* Device: Rainbow adhesive adult/neonatal sensor


Participation Criteria
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Eligibility Criteria
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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. 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
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group- Sensor 1<br>All subjects are enrolled into the test group and receive the Rainbow adhesive adult/pediatric sensors. | Device: Rainbow adhesive adult/pediatric sensor<br> <br> |
| Experimental: Group- Sensor 2<br>All subjects are enrolled into the test group and receive the Rainbow adhesive adult/neonatal sensors. | Device: Rainbow adhesive adult/neonatal sensor<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy of Noninvasive Sensors by Arms Calculation | 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 | 1-5 hours |