Accuracy of Noninvasive Hemoglobin Sensor (Rainbow Reusable DCI)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Masimo Corporation
- Enrollment
- 354
- Locations
- 1
- Primary Endpoint
- Accuracy of Sensor by Arms Calculation
Study Overview
Brief Summary
In this study, the accuracy of a noninvasive hemoglobin sensor(s) will be assessed by comparison to hemoglobin measurements from a laboratory hematology analyzer. Blood samples are collected from healthy volunteers who are enrolled in either a blood draw procedure or a hemodilution procedure wherein blood is repeatedly sampled as the concentration of hemoglobin is reduced in a controlled manner by administering fluids intravenously.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •A. Hemodilution Test Procedure
- •Inclusion Criteria:
- •Weight of more than 110 lbs and less than 220 lbs.
- •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 35 years
- •Weight of less than 110 lbs or more than 220 lbs.
- •Hemoglobin less than 12 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).
- •Subject has any medical condition which in the judgment 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 bpm.
- •Inability to tolerate sitting still or minimal movement for up to 90 minutes
- •Discretion of investigator
- •B. Blood Draw Test Procedure
- •Inclusion Criteria:
- •Subjects must understand and consent to be in the study.
- •Exclusion Criteria
- •Subjects less than 18 years of age.
- •Subjects who do not understand the study and the risks involved.
- •Anyone deemed ineligible by test personnel.
Arms & Interventions
Noninvasive Hemoglobin Sensor
All subjects are enrolled into the test group and all subjects received the Noninvasive Hemoglobin Sensor (Rainbow Reusable DCI, DCIP)
Intervention: Hemoglobin Sensor ((Rainbow Reusable DCI, DCIP)) (Device)
Outcomes
Primary Outcomes
Accuracy of Sensor 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.
Secondary Outcomes
No secondary outcomes reported