Anemia
Conditions
Brief summary
The primary objective of this clinical investigation is to evaluate the accuracy of using Masimo's INVSENSOR00026 Pulse CO-Oximeter and Sensor to measure hemoglobin, as compared to hemoglobin measurements obtained from various lab analyzer(s) and point of care device(s).
Interventions
DEVICEINVSENSOR00026 (Pulse CO-Oximeter and sensor)
Noninvasive Pulse CO-Oximeter and sensor that measures 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
* 18 years of age or older * Subject has given written informed consent to participate in the study
Exclusion criteria
* (\*) Pregnant or positive human chorionic gonadotropin (hCG) test * (\*) Any severe coagulopathy, chronic bleeding disorders (i.e., hemophilia) or recent thrombolysis * (\*) Hemoglobinopathies and synthesis disorders (i.e., sickle cell, thalassemias, etc.) * (\*) Subjects who are currently taking anticoagulant medication * (\*) Subjects with allergies to lidocaine, Pain Ease, latex, adhesives, or plastic * (\*) 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 psoriasis, eczema, angioma, burns, scar tissue, substantial skin breakdown, nail polish, acrylic nails, infections, abnormalities, etc. * (\*) 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. * (\*) Subjects with elevated blood pressure, skin or wrist abnormalities that may interfere with an arterial blood draw as determined by investigator or research medical staff. * (\*) Subjects who intend on participating in heavy lifting, repetitive movement of their wrist (including riding a motorcycle) or exercise (working out, riding a bike, etc.), or any activity that will put additional stress on the wrist within 24 hours following a study involving an arterial blood draw * Subjects deemed not suitable for the study at the discretion of the investigator or research medical staff Note: (\*) May be self-reported by subject
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Accuracy of Noninvasive Hemoglobin (SpHb) Measurement by Arms Calculation | Up to 2 hours per subject | Accuracy of the INVSENSOR00026 will be determined by comparing the noninvasive hemoglobin measurement (SpHb) of the INVSENSOR00026 to the hemoglobin value obtained from a reference blood sample and calculating the accuracy root mean square (Arms) error value. In order to obtain the Arms value, the blood sample hemoglobin value is subtracted from the INVSENSOR00026 hemoglobin value for a number of samples, the average of this difference is computed as the bias. The standard deviation of the differences is computed as the precision. The square root of the sum of the squares of bias and precision is computed as the Arms Error value. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| INVSENSOR00026 All enrolled subjects receive INVSENSOR00026 Pulse CO-Oximeter and sensor for the noninvasive measurement of hemoglobin (SpHb). | 111 |
| Total | 111 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Physician Decision | 10 |
| Overall Study | Protocol Violation | 1 |
| Overall Study | Screen fail | 4 |
| Overall Study | Unable to draw blood | 1 |
Baseline characteristics
| Characteristic | INVSENSOR00026 |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 10 Participants |
| Age, Categorical Between 18 and 65 years | 101 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 106 Participants |
| Region of Enrollment United States | 111 participants |
| Sex: Female, Male Female | 68 Participants |
| Sex: Female, Male Male | 43 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 127 |
| other Total, other adverse events | 2 / 127 |
| serious Total, serious adverse events | 0 / 127 |
Outcome results
Primary
Accuracy of Noninvasive Hemoglobin (SpHb) Measurement by Arms Calculation
Accuracy of the INVSENSOR00026 will be determined by comparing the noninvasive hemoglobin measurement (SpHb) of the INVSENSOR00026 to the hemoglobin value obtained from a reference blood sample and calculating the accuracy root mean square (Arms) error value. In order to obtain the Arms value, the blood sample hemoglobin value is subtracted from the INVSENSOR00026 hemoglobin value for a number of samples, the average of this difference is computed as the bias. The standard deviation of the differences is computed as the precision. The square root of the sum of the squares of bias and precision is computed as the Arms Error value.
Time frame: Up to 2 hours per subject
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| INVSENSOR00026 | Accuracy of Noninvasive Hemoglobin (SpHb) Measurement by Arms Calculation | 0.93 g/dL |