Spot-Check Noninvasive Hemoglobin (SpHb) Clinical Validation

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02930850

Enrollment

447

Registered

2016-10-12

Start date

2016-09-30

Completion date

2016-10-31

Last updated

2019-04-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anemia, Healthy, Pediatric ALL

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.

Interventions

DEVICERad-67 Pulse oximeter

Noninvasive pulse oximeter that measures hemoglobin

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

1 Months to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Accuracy of hemoglobin measurement	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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026