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Comparison of Noninvasive Hemoglobin Disposable Sensors

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ClinicalTrials.gov Identifier: NCT03125031
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 two noninvasive hemoglobin sensors will be assessed by comparison to hemoglobin measurements from a laboratory analyzer.

Condition or disease Intervention/treatment Phase
Healthy Device: Rainbow adhesive adult/pediatric sensor Device: Rainbow adhesive adult/neonatal sensor Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Actual Study Start Date : July 10, 2014
Actual Primary Completion Date : July 25, 2014
Actual Study Completion Date : July 25, 2014

Arm Intervention/treatment
Experimental: Group- Sensor 1
All subjects are enrolled into the test group and receive the Rainbow adhesive adult/pediatric sensors.
Device: Rainbow adhesive adult/pediatric sensor
Experimental: Group- Sensor 2
All subjects are enrolled into the test group and receive the Rainbow adhesive adult/neonatal sensors.
Device: Rainbow adhesive adult/neonatal sensor



Primary Outcome Measures :
  1. Accuracy of Noninvasive Sensors 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. The accuracy results from both sensors will be assessed for equivalence



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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 for subjects under 6 feet tall.
  • Physical status of ASA I of II
  • Able to read and communicate in English
  • Has signed written informed consent
  • Female, non pregnant.

Exclusion Criteria:

  • Age less than 18 yrs and greater than 40 years
  • If the Warming and cooling subjects have open cuts of skin abrasions on their extremities they will be excluded because alcohol spray may be painful.
  • Weight of less than 110 lbs or more than 250 lbs if the subject is less than 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): NCT03125031


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

Responsible Party: Masimo Corporation
ClinicalTrials.gov Identifier: NCT03125031     History of Changes
Other Study ID Numbers: TR26947-TP16847A
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