Rainbow DCI vs. R1-25 Sensor SpHb Sub-Range Performance Equivalence

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

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-06-19

Study Completion Date

2009-06-29

Brief Summary

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In this study, the concentration of hemoglobin was measured using noninvasive pulse oximeter sensors and compared against the hemoglobin measurement from the subject's blood sample under controlled conditions. Data collected in the study was in the sub-range of 11-17 g/dL in the device's 8-17 g/dL specification range.

The purpose of the study was to evaluate a change in the sensor component and to assess performance equivalence in the sub-range. The performance of non-invasive hemoglobin is not uniform across the accuracy range.

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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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Test Group

All subjects are enrolled into the test group and all subjects received both the Rainbow DCI and R1-25 sensor.

Group Type EXPERIMENTAL

Rainbow DCI and R1-25 sensor

Intervention Type DEVICE

Noninvasive Measurement of SpHb

Interventions

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Rainbow DCI and R1-25 sensor

Noninvasive Measurement of SpHb

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Subjects must understand and consent to be in the study.
* American Society of Anesthesiology Class 1 (Healthy subjects without any systemic disease at all).

Exclusion Criteria

* Subjects who have any systemic disease at all.
* Subjects who do not understand the study and the risks.
* Smokers.
* Subjects who are pregnant.
* Subjects having either signs or history or peripheral ischemia. Others deemed ineligible by the clinical staff.

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes