Healthy
Conditions
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.
Interventions
DEVICEHemoglobin Sensor ((Rainbow Reusable DCI, DCIP))
Measurement of Noninvasive Hemoglobin (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 No maximum
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. * 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. * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Accuracy of Sensor 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Noninvasive Hemoglobin Sensor All subjects are enrolled into the test group and all subjects received the Noninvasive Hemoglobin Sensor (Rainbow Reusable DCI, DCIP) | 354 |
| Total | 354 |
Baseline characteristics
| Characteristic | Noninvasive Hemoglobin Sensor |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 354 Participants |
| Sex: Female, Male Female | 127 Participants |
| Sex: Female, Male Male | 227 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 354 |
| serious Total, serious adverse events | 0 / 354 |
Outcome results
Primary
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.
Time frame: 1-5 hours
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Noninvasive Hemoglobin Sensor | Accuracy of Sensor by Arms Calculation | 1.0 g/dL |