Spot-Check Noninvasive Hemoglobin (SpHb) Repeatability and Reproducibility

Masimo

Status: Completed

Conditions: Anemia; Healthy

Treatments: Device: Rad-67 and DCI Mini Sensor

Study type: Interventional

Funder types: Industry

Identifiers

NCT03128853

TP-18216

Details and patient eligibility

About

Single-arm study to investigate the repeatability and reproducibility of SpHb measurements from the Rad-67 and DCI Mini sensor.

Full description

This study aims to evaluate the repeatability and reproducibility of Masimo's pulse CO-Oximeter and sensor to determine the device and sensor's precision in SpHb measurements.

Enrollment: 57 patients

Sex: All

Ages: 1+ month old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Age one month and older
• Weight greater than or equal to 3 kg
• The subject or the subject's legally authorized representative has given written informed consent/assent to participate in the study

Exclusion criteria

• Decision-impaired adult and pediatric patients who are unable to give informed consent/assent
• Decision-impaired adult on behalf of a pediatric patient who is unable to assent
• 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.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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57 participants in 1 patient group

Test subjects

Experimental group

Description:

Each subject receives the Rad-67 and DCI Mini sensor that will measure hemoglobin repeatedly in order to compare those measurements against a blood sample reference.

Treatment:

Device: Rad-67 and DCI Mini Sensor