SpO2 Accuracy Validation of Pulse Oximetry Systems During Motion and Non-Motion Conditions

Nonin Medical

Status: Completed

Conditions: Hypoxia

Treatments: Device: Pulse oximeter

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT02475668

QATP2759

Details and patient eligibility

About

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

Full description

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

Enrollment: 13 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.