Spot-Check Noninvasive Hemoglobin (SpHb) Clinical Validation
Overview
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Masimo Corporation
- Enrollment
- 447
- Locations
- 7
- Primary Endpoint
- Accuracy of hemoglobin measurement
Overview
Brief Summary
The purpose study is to report on the accuracy of noninvasive hemoglobin (SpHb) as compared to hemoglobin measurements obtained from a laboratory hematology analyzer.
Detailed Description
The primary objective of this clinical investigation is to report on the accuracy of the Rad-67 and DCI Mini sensor to measure SpHb as compared to hemoglobin measurements obtained from a manual HiCN analytical method and automated Beckman Coulter laboratory hematology analyzers.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 1 Month to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Age: Greater than one month
- •Weight: Greater than or equal to 3kg
- •The subject or the subject's legally authorized representative has given written informed consent/assent 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, 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.
- •Decision-impaired adult and pediatric subjects who are unable to give consent and assent
Outcomes
Primary Outcomes
Accuracy of hemoglobin measurement
Time Frame: Up to 2 hours 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.
Secondary Outcomes
No secondary outcomes reported