Anemia, Healthy
Conditions
Brief summary
The objective of this clinical investigation is to evaluate the pulse oximeter devices for screening prospective blood donors. The purpose study is to report on the accuracy of noninvasive hemoglobin (SpHb) as compared to hemoglobin measurements obtained from a laboratory hematology analyzer in a blood donation setting.
Interventions
Noninvasive pulse oximeter that measures 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 and/or unable 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 * Subjects 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 * Excessive motion includes postural changes, making hand gestures, involuntary muscular movements, etc.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rad-67 Sensitivity | Up to one hour per subject | Sensitivity of the the Rad-67 will be determined for its use in a blood donation center |
| Rad-67 Specificity | Up to one hour per subject | Specificity of the the Rad-67 will be determined for its use in a blood donation center |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Test Subjects All subjects are enrolled and receive Rad-67 Pulse oximeter & DCI Mini sensor for measurement of hemoglobin.
Rad-67 Pulse oximeter & DCI Mini sensor: Noninvasive pulse oximeter that measures hemoglobin | 125 |
| Total | 125 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Protocol Violation | 4 |
| Overall Study | Wrong device setting | 2 |
Baseline characteristics
| Characteristic | Test Subjects |
|---|---|
| Age, Categorical <=18 years | 1 Participants |
| Age, Categorical >=65 years | 18 Participants |
| Age, Categorical Between 18 and 65 years | 106 Participants |
| Race/Ethnicity, Customized Race American Indian or Alaska Native | 1 Participants |
| Race/Ethnicity, Customized Race Asian | 16 Participants |
| Race/Ethnicity, Customized Race Black or African American | 2 Participants |
| Race/Ethnicity, Customized Race More Than One Race | 6 Participants |
| Race/Ethnicity, Customized Race Native Hawaiian or Other Pacific Islander | 2 Participants |
| Race/Ethnicity, Customized Race Other: American | 1 Participants |
| Race/Ethnicity, Customized Race Other: Assyrian | 1 Participants |
| Race/Ethnicity, Customized Race Other: Mexican | 16 Participants |
| Race/Ethnicity, Customized Race Other: Native American | 1 Participants |
| Race/Ethnicity, Customized Race Unknown or Not Reported | 3 Participants |
| Race/Ethnicity, Customized Race White | 76 Participants |
| Region of Enrollment United States | 125 participants |
| Sex: Female, Male Female | 76 Participants |
| Sex: Female, Male Male | 49 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 131 |
| other Total, other adverse events | 0 / 131 |
| serious Total, serious adverse events | 0 / 131 |
Outcome results
Primary
Rad-67 Sensitivity
Sensitivity of the the Rad-67 will be determined for its use in a blood donation center
Time frame: Up to one hour per subject
Population: 2 subjects were excluded from analysis due to wrong device setting
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Test Subjects | Rad-67 Sensitivity | 44 percentage of sensitivity |
Primary
Rad-67 Specificity
Specificity of the the Rad-67 will be determined for its use in a blood donation center
Time frame: Up to one hour per subject
Population: 2 subjects were excluded from analysis due to wrong device setting
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Test Subjects | Rad-67 Specificity | 86.73 percentage of specificity |