Spot-Check Noninvasive Pulse CO-Oximeter Validation

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

368 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-11

Study Completion Date

2016-05-19

Brief Summary

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In this study, the accuracy of a noninvasive hemoglobin sensor(s) will be assessed by comparison to hemoglobin measurements from a laboratory analyzer.

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Detailed Description

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Conditions

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Anemia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Test group

All subjects are enrolled into the test group and receive Masimo Rad-67 Pulse Oximeter for measurement of hemoglobin.

Group Type EXPERIMENTAL

Masimo Rad-67 Pulse Oximeter

Intervention Type DEVICE

Noninvasive pulse oximeter

Interventions

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Masimo Rad-67 Pulse Oximeter

Noninvasive pulse oximeter

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Male or female
* Age: Greater than one month
* Weight: Greater than or equal to 3kg
* Any racial or ethnic group
* The subject or the subject's legally authorized representative has given written informed consent/assent to participate in the study
* If an ICU patient, total hemoglobin of \< 9 g/dL at time of screening.

Exclusion Criteria

* Subjects with skin abnormalities at the planned application sites that may interfere with sensor application, per directions-for-use (DFU) or trans-illumination of the site, such as burns, scar tissue, nail polish, acrylic nails, infections, abnormalities, etc.
* Subjects deemed not suitable for the study at the discretion of the investigator
* Subjects unlikely to be able to refrain from excessive motion during data collection. Excessive motion includes postural changes, making hand gestures, involuntary muscular movements, etc.

Minimum Eligible Age

1 Month

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes