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

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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Key information

Conditions

Healthy

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Masimo

Irvine, California, 92618, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Rainbow DCI and R1-25 sensor

Device

Noninvasive Measurement of SpHb

Primary outcomes

Sub-Range Performance Equivalence of Rainbow DCI and R1-25 Sensors by ARMS Calculation

Time frame: 1-5 hours per subject

Sub-range performance equivalence was determined by comparing the noninvasive hemoglobin measurement of the pulse oximeter sensor to the hemoglobin value obtained from a blood sample and calculating the arithmetic root mean square (Arms) error value.In order to obtain the Arms value, the blood sample hemoglobin value is subtracted from the pulse oximeter hemoglobin value for a number of samples, the average of this difference is computed as the bias. The standard deviation of these differences is computed as the precision. The square root of the sum of the squares of bias and precision is computed as the Arms Error value.

Sponsors and collaborators

Lead sponsor

Masimo Corporation

Industry

Registry information

Important dates

Study start: 2009
Primary completion: 2009
Study completion: 2009
First posted: May 17, 2017
Registry last updated: Jul 27, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed