Spot-Check Noninvasive Hemoglobin (SpHb) Clinical 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

447 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-30

Study Completion Date

2016-10-31

Brief Summary

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The purpose study is to report on the accuracy of noninvasive hemoglobin (SpHb) as compared to hemoglobin measurements obtained from a laboratory hematology analyzer.

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Detailed Description

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The primary objective of this clinical investigation is to report on the accuracy of the Rad-67 and DCI Mini sensor to measure SpHb as compared to hemoglobin measurements obtained from a manual HiCN analytical method and automated Beckman Coulter laboratory hematology analyzers.

Conditions

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Anemia Healthy Pediatric ALL

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 subjects

All subjects are enrolled and receive Rad-67 Pulse oximeter sensor for measurement of hemoglobin.

Group Type EXPERIMENTAL

Rad-67 Pulse oximeter

Intervention Type DEVICE

Noninvasive pulse oximeter that measures hemoglobin

Interventions

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Rad-67 Pulse oximeter

Noninvasive pulse oximeter that measures hemoglobin

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Age: Greater than one month
* Weight: Greater than or equal to 3kg
* The subject or the subject's legally authorized representative has given written informed consent/assent to participate in the study

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.
* Decision-impaired adult and pediatric subjects who are unable to give consent and assent

Minimum Eligible Age

1 Month

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes