Expired Study
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Louisville, Colorado 80027


Purpose:

Study to evaluate the %SpO2 accuracy performance of the Nonin Medical pulse oximetry systems.


Study summary:

Study to evaluate the %SpO2 accuracy performance of the Nonin Medical pulse oximetry systems during motion and non-motion.


Criteria:

Inclusion Criteria: - The subject is male or female - The subject is of any racial or ethnic group - The subject is > 30 kg (>66 pounds) in weight (self-reported) - The subject has at least one finger height of 0.2 - 1.0 inch (based on measurement) - The subject is between 18 years and 45 years of age (self=reported) - The subject shows no evidence of medical problems as indicated by satisfactory completion of the health assessment form - The subject has given written informed consent to participate in the study - The subject is both willing and able to comply with study procedures. Exclusion Criteria: - The subject has a BMI greater than 31 (based on weight and height) - The subject has had any relevant injury at the sensor location site (self-reported) - The subject has deformities or abnormalities that may prevent proper application of the device under test (based on examination) - The subject is current smoker (self-reported) - The subject has a known respiratory condition (self-reported) - The subject has a known heart or cardiovascular condition (self-reported) - The subject is currently pregnant (self-reported) - The subject is actively trying to get pregnant (self-reported) - The subject has a clotting disorder (self-reported) - The subject has Raynaud's Disease (self-reported) - The subject is known to have a hemoglobinopathy (self-reported) - The subject is on blood thinners or medication with aspirin (self-reported) - The subject has unacceptable collateral circulation from the ulnar artery (based on examination) - The subject is unwilling or unable to provide written informed consent to participate in the study - The subject is unwilling or unable to comply with the study procedures - The subject has another health condition which in the opinion of the principal investigator makes him/her unsuitable for testing.


NCT ID:

NCT02475668


Primary Contact:

Principal Investigator
Dave Ransom, MD
Avista Adventis Hospital


Backup Contact:

N/A


Location Contact:

Louisville, Colorado 80027
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: November 21, 2017

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