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Accuracy of Hemoglobin Measurement for Various Rainbow Pulse Oximeter Sensors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03124966
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):

Study Description
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
Healthy Device: Pulse Oximeter sensor

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 118 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Actual Study Start Date : December 9, 2009
Primary Completion Date : December 31, 2009
Study Completion Date : December 31, 2009
Arms and Interventions

Arm Intervention/treatment
Experimental: Noninvasive Hemoglobin Sensor
All subjects are enrolled into the test group and all will receive the pulse oximeter sensor.
Device: Pulse Oximeter sensor


Outcome Measures

Primary Outcome Measures :
  1. Accuracy of Sensor by Arms Calculation [ Time Frame: 1-3 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.


Eligibility Criteria

Information from the National Library of Medicine

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

Study Site 1:

Inclusion Criteria:

  • Has physical status between ASA 1 or 2
  • Able to communicate in English

Exclusion Criteria:

  • Pregnant or sexually active without birth control.
  • Hemoglobin less than 11g/dL
  • Known alcohol or drug abuse
  • Skin abnormalities affecting the digits such as psoriasis, eczema, angioma, scar tissue, burn, fungal infection
  • Nail polish
  • Head injury with loss of consciousness within the last year
  • Known neurological and psychiatric conditions.
  • Known concurrent chronic usage of psychoactive or anti-convulsive drugs within the last 90 days, or use in the last 7 days (i.e. tricyclic antidepressants, MAO inhibitors, lithium, neuroleptics, anxiolytics or antipsychotics. Except SSRIs
  • Subject has any medical condition which, in the judgement of the investigator, renders them inappropriate for participation in this study, such as Raynaud's syndrome
  • Hypertension: Systolic BP >= 140 mmHg or Diastolic BP >= 90 mmHg
  • Baseline heart rate <50 beats per minute

Study Site 2:

Inclusion Criteria:

  • Male or female
  • 18-35 years of age
  • Physical status of ASA I or II
  • Able to read and communicate in English
  • Has signed written informed consent
  • If female, non pregnant. If female subject is currently sexually active and not on birth control they must have a negative pregnancy test prior to study enrollment.

Exclusion Criteria

  • Age less than 18 yrs and greater than 35 years
  • Hemoglobin less than 12 g/dL
  • ASA physical status of III, IV, or V
  • Pregnant or sexually active without birth control
  • 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, lithium, 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 Raynauds 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
Contacts and Locations

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): NCT03124966


Locations
United States, California
Masimo Clinical Lab
Irvine, California, United States, 92618
Loma Linda University Medical Center
Loma Linda, California, United States, 92354
Sponsors and Collaborators
Masimo Corporation
More Information

Responsible Party: Masimo Corporation
ClinicalTrials.gov Identifier: NCT03124966     History of Changes
Other Study ID Numbers: TR19443-56044
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