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Completed

NCT Number: NCT03030833

Dysfunctional Hemoglobin Pulse Oximetry

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

Completed

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Key information

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Observational

Primary location

HPPL Duke Univeristy

Durham, North Carolina, 27710, United States

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pulse Oximeter

Device

Comparison of pulse oximetry to blood gas analyzer.

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Nonin Medical, Inc

Industry

Registry information

Official study title

Dysfunctional Hemoglobin Pulse Oximeter

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Jan 25, 2017
Registry last updated
Sep 1, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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