SpO2 Hypoxia Accuracy Validation Study

Completed

Conditions studied: Hypoxia

In brief

The primary objective of this study is to evaluate the % oxygen saturation by pulse oximetry accuracy of a combined pulse oximetry system which consists of a Nonin sensor ), an adaptor cable, and an oximetry system during non-motion conditions.

Key facts

Study ID

NCT03348189

Run by

Nonin Medical, Inc

People needed

12

Starts

2017-11-01

Expected to finish

2017-11-03

Last updated by the study team

2017-11-20

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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 50 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.

You may not qualify if…

• 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, is actively trying to get pregnant, or who has a positive urine pregnancy test on the day of the study
• 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.

Where it is running

• Clinimark — Louisville, Colorado, United States

Full record on ClinicalTrials.gov

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