Pulse CO-Oximetry Noninvasive Monitoring and Laboratory Measurements of Subject Blood Samples

Masimo

Status: Completed

Conditions: Various Comorbidities

Treatments: Device: Noninvasive device

Study type: Interventional

Funder types: Industry

Identifiers

NCT01638455

Masimo-Noninvasive 1

Details and patient eligibility

About

Characterize Masimo noninvasive technology in spot check reading on subjects and make comparison to invasive blood sampling tested on reference analyzers.

Full description

Noninvasive readings from subjects done according to manufacturer's directions of use compared to simultaneously derived blood samples measured on in vitro analyzers

Enrollment: 2,776 patients

Sex: All

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Male or female of any age ≥ 3 kg.
• Subjects may include healthy volunteers, outpatient or inpatient populations

Exclusion criteria

• Subjects with skin abnormalities at the planned application sites that may interfere with sensor application or trans-illumination of the site, such as burns, scar tissue, nail polish, acrylic nails, infections, etc.
• Subjects deemed not suitable for study at the discretion of the investigator

Trial design

2,776 participants in 1 patient group

Test Group

Experimental group

Description:

All subjects will be enrolled in the test group and will receive the noninvasive device

Treatment:

Device: Noninvasive device