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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

2776 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-30

Study Completion Date

2016-09-07

Brief Summary

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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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Detailed Description

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

Conditions

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Various Comorbidities

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Study Groups

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Test Group

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

Group Type EXPERIMENTAL

Noninvasive device

Intervention Type DEVICE

Noninvasive device

Interventions

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Noninvasive device

Intervention Type DEVICE

Eligibility Criteria

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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

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes