Accuracy of Hemoglobin Measurement for Various Rainbow Pulse Oximeter 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 a noninvasive hemoglobin sensor(s) 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: Pulse Oximeter sensor


Participation Criteria
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Eligibility Criteria
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Study Site 1: Inclusion Criteria: Has physical status between ASA 1 or 2 Able to communicate in English Exclusion Criteria: Pregnant or sexually active without birth control. Hemoglobin less than 11g/dL Known alcohol or drug abuse Skin abnormalities affecting the digits such as psoriasis, eczema, angioma, scar tissue, burn, fungal infection Nail polish Head injury with loss of consciousness within the last year Known neurological and psychiatric conditions. Known concurrent chronic usage of psychoactive or anti-convulsive drugs within the last 90 days, or use in the last 7 days (i.e. tricyclic antidepressants, MAO inhibitors, lithium, neuroleptics, anxiolytics or antipsychotics. Except SSRIs Subject has any medical condition which, in the judgement of the investigator, renders them inappropriate for participation in this study, such as Raynaud's syndrome Hypertension: Systolic BP >= 140 mmHg or Diastolic BP >= 90 mmHg Baseline heart rate <50 beats per minute Study Site 2: Inclusion Criteria: Male or female 18-35 years of age Physical status of ASA I or II Able to read and communicate in English Has signed written informed consent If female, non pregnant. If female subject is currently sexually active and not on birth control they must have a negative pregnancy test prior to study enrollment. Exclusion Criteria Age less than 18 yrs and greater than 35 years Hemoglobin less than 12 g/dL ASA physical status of III, IV, or V Pregnant or sexually active without birth control 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, lithium, 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 Raynauds 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

Ages Eligible for Study
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Minimum Age: 18 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Noninvasive Hemoglobin Sensor<br>All subjects are enrolled into the test group and all will receive the pulse oximeter sensor. | Device: Pulse Oximeter sensor<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy of Sensor 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. | 1-3 hours |