Spot-Check Noninvasive Hemoglobin (SpHb) Clinical Validation

Masimo

Status

Completed

Conditions

Anemia

Healthy

Pediatric ALL

Treatments

Device: Rad-67 Pulse oximeter

Study type

Interventional

Funder types

Industry

Identifiers

NCT02930850

TORR0002

Details and patient eligibility

About

The purpose study is to report on the accuracy of noninvasive hemoglobin (SpHb) as compared to hemoglobin measurements obtained from a laboratory hematology analyzer.

Full 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.

Enrollment

447 patients

Sex

All

Ages

1+ month old

Volunteers

Accepts Healthy Volunteers

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