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 two noninvasive hemoglobin sensors will be assessed by comparison to hemoglobin measurements from a laboratory analyzer.
Interventions
DEVICERainbow adhesive adult/pediatric sensor
DEVICERainbow adhesive adult/neonatal sensor
Sponsors
Masimo Corporation
Study design
Allocation
NON_RANDOMIZED
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 for subjects under 6 feet tall. * Physical status of ASA I of II * Able to read and communicate in English * Has signed written informed consent * Female, non pregnant.
Exclusion criteria
* Age less than 18 yrs and greater than 40 years * If the Warming and cooling subjects have open cuts of skin abrasions on their extremities they will be excluded because alcohol spray may be painful. * Weight of less than 110 lbs or more than 250 lbs if the subject is less than 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 Noninvasive Sensors by Arms Calculation | 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. The accuracy results from both sensors will be assessed for equivalence |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Rainbow Adhesive Adult/Pediatric and Adult/Neonatal Sensors All subjects are enrolled into the test group and receive the Rainbow adhesive sensors (adult/pediatric and adult/neonatal sensors). | 44 |
| Total | 44 |
Baseline characteristics
| Characteristic | Rainbow Adhesive Adult/Pediatric and Adult/Neonatal Sensors |
|---|---|
| Age, Customized 18-38 years | 44 Participants |
| Sex: Female, Male Female | 12 Participants |
| Sex: Female, Male Male | 32 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 44 |
| serious Total, serious adverse events | 0 / 44 |
Outcome results
Primary
Accuracy of Noninvasive Sensors 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. The accuracy results from both sensors will be assessed for equivalence
Time frame: 1-5 hours
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group-Sensor 1 | Accuracy of Noninvasive Sensors by Arms Calculation | 1.0 g/dL |
| Group-Sensor 2 | Accuracy of Noninvasive Sensors by Arms Calculation | 1.0 g/dL |