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Accuracy of Noninvasive Hemoglobin Pulse Oximeter (Rainbow Resposable Adhesive Sensors)

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ClinicalTrials.gov Identifier: NCT03124771
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 concentration of hemoglobin within the subject's blood will be reduced in a controlled manner by administering fluids intravenously. The accuracy of a noninvasive hemoglobin sensor(s) will be assessed by comparison to hemoglobin measurements from a laboratory analyzer.

Condition or disease Intervention/treatment Phase
Healthy Device: Rainbow Resposable Adhesive Sensors Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 132 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Actual Study Start Date : December 27, 2011
Actual Primary Completion Date : April 3, 2012
Actual Study Completion Date : April 3, 2012

Arm Intervention/treatment
Experimental: Rainbow Resposable Adhesive Sensors
All subjects are enrolled into the test group and all subjects received the Rainbow Resposable Adhesive Sensors.
Device: Rainbow Resposable Adhesive Sensors
Noninvasive Measurement of SpHb




Primary Outcome Measures :
  1. Accuracy of Sensor by Arms Calculation [ Time Frame: 1-5 hours ]
    Accuracy willl 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 to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Male or female
  • 18-40 years of age
  • Weight of at least 110 lbs and less than 250 lbs or a BMI under 36 for subjects taller than 6 feet.
  • 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 40 years
  • Weight of less than 110 lbs or more than 250 lbs. or a BMI of 36 or greater for people over 6 feet tall.
  • Hemoglobin less than 11 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.
  • Systolic BP >140 mmHg or Diastolic BP > 100 mmHg.
  • Baseline heart rate < 50 bpm.
  • Inability to tolerate sitting still or minimal movement for up to 90 minutes
  • Discretion of investigator

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): NCT03124771


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

Responsible Party: Masimo Corporation
ClinicalTrials.gov Identifier: NCT03124771     History of Changes
Other Study ID Numbers: TR23394-TP16171
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
Product Manufactured in and Exported from the U.S.: No