Accuracy of Noninvasive Hemoglobin Pulse Oximeter (Rainbow Resposable Adhesive Sensors)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Masimo Corporation
- Enrollment
- 132
- Locations
- 2
- Primary Endpoint
- Accuracy of Sensor by Arms Calculation
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 40 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
- •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
Arms & Interventions
Rainbow Resposable Adhesive Sensors
All subjects are enrolled into the test group and all subjects received the Rainbow Resposable Adhesive Sensors.
Intervention: Rainbow Resposable Adhesive Sensors (Device)
Outcomes
Primary Outcomes
Accuracy of Sensor by Arms Calculation
Time Frame: 1-5 hours
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.
Secondary Outcomes
No secondary outcomes reported