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

Noninvasive Parameter Testing With Pulse CO-Oximetry and Measurement of Blood Constituents With In-Vitro Analyzers

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01638455

Enrollment

2776

Registered

2012-07-11

Start date

2012-06-30

Completion date

2016-09-07

Last updated

2017-05-15

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

Conditions

Various Comorbidities

Brief summary

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

Detailed description

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

Interventions

DEVICENoninvasive device

Noninvasive device

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

OTHER

Eligibility

Sex/Gender

ALL

Healthy volunteers

Yes

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

Countries

United States

Outcome results

None listed

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