Healthy
Conditions
Brief summary
The primary objective of this clinical investigation is to evaluate the repeatability and reproducibility of using Rad-67 Pulse CO-Oximeter
Interventions
DEVICERad-67 Pulse CO-Oximeter and DCI Mini sensor
Noninvasive Pulse CO-Oximeter device and sensor are used to measure hemoglobin.
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
* At least 18 years of age * Weight at least 110 pounds * Subjects with the intention of being screened for eligibility to donate blood * The subject has given written informed consent to participate in the study
Exclusion criteria
* Subjects with skin abnormalities at the planned application sites that may interfere with sensor application, per directions-for-use (DFU) or trans-illumination of the site, such as burns, scar tissue, infections, abnormalities, etc. * Subjects unwilling to remove nail polish or acrylic nails * Subjects with blood cancers such as leukemia * Subjects with hemoglobin disorders such as sickle-cell anemia and thalassemia or with known history of infectious diseases such as HIV/AIDS, syphilis, hepatitis, etc. * Subjects with self-disclosed/known pregnancy at the time of enrollment * Subjects deemed not suitable for the study at the discretion of the investigator * Subjects unlikely to be able to refrain from excessive motion during data collection. Excessive motion includes postural changes, making hand gestures, involuntary muscular movements, etc.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Variation Ratio of Total Repeatability and Reproducibility Hemoglobin Measurements Using Rad-67. | 1 hour | Quality of hemoglobin measurements is defined as a variance ratio of total Gage repeatability and reproducibility variance to total variance. Subject, operator and device were considered as components to calculate this ratio. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Test Subjects All subjects are enrolled and receive Rad-67 Pulse Oximeter and DCI Mini sensor for measurement of hemoglobin.
Rad-67 Pulse CO-Oximeter and DCI Mini sensor: Noninvasive Pulse CO-Oximeter device and sensor are used to measure hemoglobin. | 20 |
| Total | 20 |
Baseline characteristics
| Characteristic | Test Subjects |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 1 Participants |
| Age, Categorical Between 18 and 65 years | 19 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 0 Participants |
| Race/Ethnicity, Customized Asian | 2 Participants |
| Race/Ethnicity, Customized Black or African American | 0 Participants |
| Race/Ethnicity, Customized Hispanic | 9 Participants |
| Race/Ethnicity, Customized More Than One Race | 0 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 1 Participants |
| Race/Ethnicity, Customized Unknown or Not Reported | 0 Participants |
| Race/Ethnicity, Customized White | 8 Participants |
| Region of Enrollment United States | 20 participants |
| Sex: Female, Male Female | 9 Participants |
| Sex: Female, Male Male | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 20 |
| other Total, other adverse events | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 |
Outcome results
Primary
Variation Ratio of Total Repeatability and Reproducibility Hemoglobin Measurements Using Rad-67.
Quality of hemoglobin measurements is defined as a variance ratio of total Gage repeatability and reproducibility variance to total variance. Subject, operator and device were considered as components to calculate this ratio.
Time frame: 1 hour
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Test Subjects | Variation Ratio of Total Repeatability and Reproducibility Hemoglobin Measurements Using Rad-67. | 10 ratio of variance |