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Accuracy of Noninvasive Hemoglobin Sensor (Rainbow Reusable DCI)

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ClinicalTrials.gov Identifier: NCT03124758
Recruitment Status : Completed
First Posted : April 24, 2017
Results First Posted : June 6, 2017
Last Update Posted : July 27, 2017
Sponsor:
Information provided by (Responsible Party):
Masimo Corporation

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Healthy Device: Hemoglobin Sensor ((Rainbow Reusable DCI, DCIP)) Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 354 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Actual Study Start Date : April 20, 2010
Actual Primary Completion Date : October 31, 2011
Actual Study Completion Date : October 31, 2011

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)




Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03124758


Locations
United States, California
Masimo Corporation
Irvine, California, United States, 92618
Sponsors and Collaborators
Masimo Corporation

Responsible Party: Masimo Corporation
ClinicalTrials.gov Identifier: NCT03124758     History of Changes
Other Study ID Numbers: TR24577-TP15879-TP14065
First Posted: April 24, 2017    Key Record Dates
Results First Posted: June 6, 2017
Last Update Posted: July 27, 2017
Last Verified: June 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No