Accuracy of Noninvasive Hemoglobin Sensor (Rainbow Reusable DCI)

June 28, 2017 updated by: Masimo Corporation
In this study, the accuracy of a noninvasive hemoglobin sensor(s) will be assessed by comparison to hemoglobin measurements from a laboratory hematology analyzer. Blood samples are collected from healthy volunteers who are enrolled in either a blood draw procedure or a hemodilution procedure wherein blood is repeatedly sampled as the concentration of hemoglobin is reduced in a controlled manner by administering fluids intravenously.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

354

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Irvine, California, United States, 92618
        • Masimo Corporation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

A. Hemodilution Test Procedure

Inclusion Criteria:

  • Weight of more than 110 lbs and less than 220 lbs.
  • Physical status of ASA I of II
  • Able to read and communicate in English
  • Has signed written informed consent
  • Female, non pregnant. Female subjects will be provided with a pregnancy test free of charge.

Exclusion Criteria

  • Age less than 18 yrs and greater than 35 years
  • Weight of less than 110 lbs or more than 220 lbs.
  • Hemoglobin less than 12 g/dL
  • ASA physical status of III. IV, V.
  • Pregnant
  • Subject has known drug or alcohol abuse
  • Subject has skin abnormalities affecting the digits such as psoriasis, eczema, angioma, scar tissue, burn, fungal infection, substantial skin breakdown, nail polish or acrylic nails.
  • Subject has experienced a head injury with loss of consciousness within the last year
  • Subject has known neurological and psychiatric disorder that interferes with the subjects level of consciousness
  • Known or concurrent chronic usage of psychoactive or anticonvulsive drugs within the last 90 days, or any use in the last 7 day (i.e. tricyclic antidepressants, MAO inhibitors, Lithum, neuroleptics, anxiolytics or antipsychotics, except SSRIs).
  • Subject has any medical condition which in the judgment of the investigator, renders them inappropriate for participation in this study, such as Reynauds Syndrome.
  • Hypertension: Systolic BP >140 mmHg or Diastolic BP > 90 mmHg.
  • Baseline heart rate < 50 bpm.
  • Inability to tolerate sitting still or minimal movement for up to 90 minutes
  • Discretion of investigator

B. Blood Draw Test Procedure

Inclusion Criteria:

-Subjects must understand and consent to be in the study.

Exclusion Criteria

  • Subjects less than 18 years of age.
  • Subjects who do not understand the study and the risks involved.
  • Anyone deemed ineligible by test personnel.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Noninvasive Hemoglobin Sensor
All subjects are enrolled into the test group and all subjects received the Noninvasive Hemoglobin Sensor (Rainbow Reusable DCI, DCIP)
Device: Hemoglobin Sensor ((Rainbow Reusable DCI, DCIP))
Measurement of Noninvasive Hemoglobin (SpHb)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Accuracy of Sensor by Arms Calculation
Time Frame: 1-5 hours
Accuracy will be determined by comparing the noninvasive hemoglobin measurement of the pulse oximeter to the hemoglobin value obtained from a blood sample and calculating the arithmetic root mean square(Arms) error value.
1-5 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Masimo Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 20, 2010

Primary Completion (Actual)

October 31, 2011

Study Completion (Actual)

October 31, 2011

Study Registration Dates

First Submitted

April 14, 2017

First Submitted That Met QC Criteria

April 20, 2017

First Posted (Actual)

April 24, 2017

Study Record Updates

Last Update Posted (Actual)

July 27, 2017

Last Update Submitted That Met QC Criteria

June 28, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TR24577-TP15879-TP14065

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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