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Dysfunctional Hemoglobin Pulse Oximetry

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: NCT03030833
Recruitment Status : Completed
First Posted : January 25, 2017
Last Update Posted : September 1, 2017
Sponsor:
Information provided by (Responsible Party):
Nonin Medical, Inc

Brief Summary:
The purpose of the study is to assess device performance in the presence of carbon monoxide.

Condition or disease Intervention/treatment
Carbon Monoxide Poisoning Device: Pulse Oximeter

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Study Type : Observational
Actual Enrollment : 36 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Dysfunctional Hemoglobin Pulse Oximeter
Actual Study Start Date : February 6, 2017
Actual Primary Completion Date : April 30, 2017
Actual Study Completion Date : April 30, 2017

Resource links provided by the National Library of Medicine



Intervention Details:
  • Device: Pulse Oximeter
    Comparison of pulse oximetry to blood gas analyzer.


Primary Outcome Measures :
  1. Carboxyhemoglobin accuracy [ Time Frame: Through study completion, an average of 3 months. ]
    Values from the test device will be compared to the values from co-oximetry to determine accuracy of the test device.



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Healthy male and females.
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 50 years of age (self-reported).
  • The subject does not have significant medical problems (self-reported).
  • 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 30.0 (calculated from self-reported weight and height).
  • Has had any relevant injury at the sensor location site (self-reported).
  • Has a deformity or abnormalities that may prevent proper application of the device under test (based on visual inspection).
  • Has a known respiratory condition (self-reported).
  • Is currently a smoker (self-reported).
  • Has a known heart or cardiovascular condition (self-reported).
  • Is currently pregnant (positive serum pregnancy test at screening visit or positive urine POC test on day of study).
  • Is female and actively trying to get pregnant (self-reported).
  • Has a clotting disorder (self-reported).
  • Has Raynaud's Disease (self-reported).
  • Is known to have anemia (hemoglobin value below lower range of normal for gender)
  • Is known to have a hemoglobinopathy such as sickle-cell anemia or thalassemia (abnormal hemoglobin electrophoresis).
  • Is known to have a inherited or congenital methemoglobinemia (self-reported).
  • Has unacceptable collateral circulation from the ulnar artery (based on exam).
  • Is unwilling or unable to provide written informed consent to participate in the study.
  • 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): NCT03030833


Locations
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United States, North Carolina
HPPL Duke Univeristy
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Nonin Medical, Inc
Investigators
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Principal Investigator: David B MacLeod, MD Duke University

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Responsible Party: Nonin Medical, Inc
ClinicalTrials.gov Identifier: NCT03030833     History of Changes
Other Study ID Numbers: QATP3040
First Posted: January 25, 2017    Key Record Dates
Last Update Posted: September 1, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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.: Yes
Additional relevant MeSH terms:
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Poisoning
Carbon Monoxide Poisoning
Chemically-Induced Disorders
Gas Poisoning