Dysfunctional Hemoglobin CO-ox

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

27 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-04-30

Study Completion Date

2015-05-31

Brief Summary

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

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Detailed Description

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Conditions

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Elevated Levels of Carboxyhemoglobin

Study Design

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Study Time Perspective

PROSPECTIVE

Interventions

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Pulse Co-Ox

Comparison of pulse co-oximeter to blood gas analyzer.

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes