Spot-Check Noninvasive Pulse CO-Oximeter Validation

Masimo

Status

Completed

Conditions

Anemia

Treatments

Device: Masimo Rad-67 Pulse Oximeter

Study type

Interventional

Funder types

Industry

Identifiers

NCT02782806

TORR0001

Details and patient eligibility

About

In this study, the accuracy of a noninvasive hemoglobin sensor(s) will be assessed by comparison to hemoglobin measurements from a laboratory analyzer.

Enrollment

368 patients

Sex

All

Ages

1+ month old

Volunteers

Accepts Healthy Volunteers

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.