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Dysfunctional Hemoglobin CO-ox

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: NCT02427685
Recruitment Status : Completed
First Posted : April 28, 2015
Last Update Posted : June 17, 2015
Sponsor:
Information provided by (Responsible Party):
Nonin Medical, Inc

Brief Summary:
The study verifies accuracy of a new pulse co-oximeter in the presence of elevated carboxyhemoglobin levels.

Condition or disease Intervention/treatment
Elevated Levels of Carboxyhemoglobin Device: Pulse Co-Ox

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Study Type : Observational
Actual Enrollment : 27 participants
Time Perspective: Prospective
Official Title: Dysfunctional Hemoglobin
Study Start Date : April 2015
Actual Primary Completion Date : May 2015
Actual Study Completion Date : May 2015

Intervention Details:
  • Device: Pulse Co-Ox
    Comparison of pulse co-oximeter to blood gas analyzer.


Primary Outcome Measures :
  1. Carboxyhemoglobin over the range of 0-15 percent as assessed by co-oximetry. [ Time Frame: 3 hours ]

Secondary Outcome Measures :
  1. Oxygen saturation accuracy in conditions of elevated carboxyhemoglobin. [ Time Frame: 3 hours ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Healthy adult volunteers
Criteria

Inclusion Criteria:

  • The subject is male or female.
  • The subject is of any racial or ethnic group.
  • The subject is between 18 years and 45 years of age.
  • The subject does not have significant medical problems.
  • The subject is willing to provide written informed consent and is willing and able to comply with study procedures.

Exclusion Criteria:

  • Has a BMI greater than 31
  • Has had any relevant injury at the sensor location site
  • Has deformities or abnormalities that may prevent proper application of the device under test.
  • Has a known respiratory condition.
  • Is currently a smoker.
  • Has a known heart or cardiovascular condition.
  • Is currently pregnant.
  • Is female and actively trying to get pregnant.
  • Has a clotting disorder.
  • Has Raynaud's Disease.
  • Is known to have a hemoglobinopathy such as (anemia, bilirubinemia, sickle-cell anemia, inherited or congenital methemoglobinemia).
  • The subject has a COHb greater than 3% or MetHb greater than 2%.
  • Has taken blood thinners or medication with aspirin within the last 24 hours.
  • Has unacceptable collateral circulation from the ulnar artery.
  • Has donated more than 300 mL of blood within one month prior to start of study.
  • Is unwilling or unable to provide written informed consent to participate in the study.
  • Is unwilling or unable to comply with the study procedures for the primary objectives.
  • Has another health condition which in the opinion of the principal investigator makes him/her unsuitable for testing.

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): NCT02427685


Locations
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United States, California
University of California San Francisco
San Francisco, California, United States, 94118
Sponsors and Collaborators
Nonin Medical, Inc
Investigators
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Principal Investigator: Phillip E Bickler, MD, PhD University of California, San Francisco
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Responsible Party: Nonin Medical, Inc
ClinicalTrials.gov Identifier: NCT02427685    
Other Study ID Numbers: QATP2687
First Posted: April 28, 2015    Key Record Dates
Last Update Posted: June 17, 2015
Last Verified: April 2015