Anemia
Conditions
Keywords
Noninvasive, Pulse, CO-Oximeter, Validation
Brief summary
In this study, the accuracy of a noninvasive hemoglobin sensor(s) will be assessed by comparison to hemoglobin measurements from a laboratory analyzer.
Interventions
DEVICEMasimo Rad-67 Pulse Oximeter
Noninvasive pulse oximeter
Sponsors
Masimo Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Months to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Male or female * Age: Greater than one month * Weight: Greater than or equal to 3kg * Any racial or ethnic group * The subject or the subject's legally authorized representative has given written informed consent/assent to participate in the study * If an ICU patient, total hemoglobin of \< 9 g/dL at time of screening.
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, nail polish, acrylic nails, infections, abnormalities, etc. * 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 |
|---|---|---|
| Accuracy of sensor | Up to 1 hr per subject | Accuracy willl 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
Outcome results
None listed