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OpenTrials
Completed

NCT Number: NCT02427685

Dysfunctional Hemoglobin CO-ox

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

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Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of California San Francisco

San Francisco, California, 94118, United States

Who can participate

Healthy volunteers accepted: Yes

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 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.

Treatment and study plan

Pulse Co-Ox

Device

Comparison of pulse co-oximeter to blood gas analyzer.

Primary outcomes

  1. Carboxyhemoglobin over the range of 0-15 percent as assessed by co-oximetry.

    Time frame: 3 hours

Secondary outcomes

  1. Oxygen saturation accuracy in conditions of elevated carboxyhemoglobin.

    Time frame: 3 hours

Sponsors and collaborators

Lead sponsor

Nonin Medical, Inc

Industry

Registry information

Official study title

Dysfunctional Hemoglobin

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Apr 28, 2015
Registry last updated
Jun 17, 2015

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.