Accuracy of Noninvasive Hemoglobin Measurement (SpHb) Using Rainbow DCI Pulse Oximeter Sensor

Study Overview
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Brief Summary
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In this study, the concentration of hemoglobin within the subject's blood is affected by fluid status changes. The fluid status is affected by fluid loss during surgery for hospitalized study subjects or controlled administration of fluids intravenously for healthy study volunteers. The accuracy of a noninvasive hemoglobin sensor(s) will be assessed by comparing with blood sample analysis.

Conditions
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Healthy, Surgery

Intervention / Treatment
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* Device: Rainbow DCI pulse oximeter sensor


Participation Criteria
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Eligibility Criteria
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Healthy Volunteers 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 Reynauds syndrome Hypertension: Systolic BP >= 140 mmHg or Diastolic BP >= 90 mmHg Baseline heart rate <50 beats per minute Surgical Subjects Inclusion Criteria: Age > 18 years old Scheduled for surgery requiring frequent schedule blood draws as a part of their routine care Exclusion Criteria: Pregnant or lactating women Skin abnormalities at the planed application sites that would interfere with transilluminating the finger, or other measurement sites, like burns, scar tissue, nail polish, infections etc.

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: Test Group<br>All subjects are enrolled into the test group and all subjects received the Rainbow DCI pulse oximeter sensor. | Device: Rainbow DCI 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. | Up to 24 hours |