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
DEVICEPulse Oximeter sensor
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
Study Site 1: Inclusion Criteria: * Has physical status between ASA 1 or 2 * Able to communicate in English
Exclusion criteria
* Pregnant or sexually active without birth control. * Hemoglobin less than 11g/dL * Known alcohol or drug abuse * Skin abnormalities affecting the digits such as psoriasis, eczema, angioma, scar tissue, burn, fungal infection * Nail polish * Head injury with loss of consciousness within the last year * Known neurological and psychiatric conditions. * Known concurrent chronic usage of psychoactive or anti-convulsive drugs within the last 90 days, or use in the last 7 days (i.e. tricyclic antidepressants, MAO inhibitors, lithium, neuroleptics, anxiolytics or antipsychotics. Except SSRIs * Subject has any medical condition which, in the judgement of the investigator, renders them inappropriate for participation in this study, such as Raynaud's syndrome * Hypertension: Systolic BP \>= 140 mmHg or Diastolic BP \>= 90 mmHg * Baseline heart rate \<50 beats per minute Study Site 2: Inclusion Criteria: * Male or female * 18-35 years of age * Physical status of ASA I or II * Able to read and communicate in English * Has signed written informed consent * If female, non pregnant. If female subject is currently sexually active and not on birth control they must have a negative pregnancy test prior to study enrollment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Accuracy of Sensor by Arms Calculation | 1-3 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 will receive the pulse oximeter sensor. | 118 |
| Total | 118 |
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 | 118 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 118 participants | — |
| Sex: Female, Male Female | 40 Participants | — |
| Sex: Female, Male Male | 78 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 118 |
| other Total, other adverse events | 0 / 118 |
| serious Total, serious adverse events | 0 / 118 |
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: 1-3 hours
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Noninvasive Hemoglobin Sensor | Accuracy of Sensor by Arms Calculation | 0.96 g/dL |