Accuracy of Noninvasive Rainbow Adhesive R1 Pulse Oximeter Sensor

NCT ID: NCT03134313

Last Updated: 2017-07-02

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-12-12

Study Completion Date

2009-06-19

Brief Summary

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In this study, the concentration of hemoglobin will be measured using a noninvasive pulse oximeter sensor and compared with the hemoglobin value from a blood sample of the volunteer. The accuracy of a noninvasive hemoglobin sensor(s) will be assessed by comparison to hemoglobin measurements from a laboratory analyzer.

Detailed Description

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Conditions

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Healthy

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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R1-25 Sensor

All subjects will be enrolled in the test group and will receive Rainbow Adhesive Noninvasive R1 Pulse Oximeter Sensor

Group Type EXPERIMENTAL

Rainbow Adhesive Noninvasive R1 Pulse Oximeter Sensor

Intervention Type DEVICE

Interventions

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Rainbow Adhesive Noninvasive R1 Pulse Oximeter Sensor

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Greater than 18 years old
* Healthy

Exclusion Criteria

* Do not understand the study and the risks involved
* Deemed ineligible by study test personnel
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Masimo Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Masimo Clinical Lab

Irvine, California, United States

Site Status

Countries

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United States

Other Identifiers

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TR18670-1029

Identifier Type: -

Identifier Source: org_study_id

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