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

NCT03157232 | Completed Results FDA Device

• 1 other identifier: TR18695-TP14480
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

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

  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.

  1-5 hours per subject

Study Arms (1)

Test Group

EXPERIMENTAL

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

Device: Rainbow DCI and R1-25 sensor

Interventions

Rainbow DCI and R1-25 sensor DEVICE

Noninvasive Measurement of SpHb

Test Group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Masimo Corporation: lead

Study Sites (1)

Masimo

Irvine, California, 92618, United States

Location

Results Point of Contact

• Title: Tala Harake
• Organization: Masimo

studies@masimo.com

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2017
• First Posted: May 17, 2017
• Study Start: June 19, 2009
• Primary Completion: June 29, 2009
• Study Completion: June 29, 2009
• Last Updated: July 27, 2017
• Results First Posted: July 27, 2017

Record last verified: 2017-06

Locations

US (1)