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OpenTrials
Completed

NCT Number: NCT01638455

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

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

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Masimo

Irvine, California, 92618, United States

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Noninvasive device

Device

Noninvasive device

Sponsors and collaborators

Lead sponsor

Masimo Corporation

Industry

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Jul 11, 2012
Registry last updated
May 15, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.