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

Not Applicable

Completed

• Conditions: Various Comorbidities
• Interventions: Device: Noninvasive device

• Registration Number: NCT01638455
• Lead Sponsor: Masimo Corporation

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

Study Timeline

• Study Start: 2012-06
• Study First Submitted: 2012-07-09
• Study First Submitted QC: 2012-07-10
• Study First Posted: 2012-07-11
• Primary Completion: 2016-09-07
• Study Completion: 2016-09-07
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-11
• Last Update Posted: 2017-05-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2776

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Test Group	Noninvasive device	All subjects will be enrolled in the test group and will receive the noninvasive device

Trial Locations

Locations (1)

Masimo; 🇺🇸 Irvine, California, United States