Healthy
Conditions
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.
Interventions
DEVICERainbow Resposable Adhesive Sensors
Noninvasive Measurement of SpHb
Sponsors
Masimo Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
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. * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Accuracy of Sensor by Arms Calculation | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Rainbow Resposable Adhesive Sensors All subjects are enrolled into the test group and all subjects received the Rainbow Resposable Adhesive Sensor. | 132 |
| Total | 132 |
Baseline characteristics
| Characteristic | Rainbow Resposable Adhesive Sensors |
|---|---|
| Age, Customized 18-40 years | 132 Participants |
| Sex: Female, Male Female | 65 Participants |
| Sex: Female, Male Male | 67 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 132 |
| serious Total, serious adverse events | 0 / 132 |
Outcome results
Primary
Accuracy of Sensor by Arms Calculation
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.
Time frame: 1-5 hours
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Rainbow Resposable Adhesive Sensor | Accuracy of Sensor by Arms Calculation | 1.0 g/dL |