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

Completed

• Conditions: Hypoxia

• Registration Number: NCT02475668
• Lead Sponsor: Nonin Medical, Inc

Brief Summary

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

Detailed Description

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

Study Timeline

• Study Start: 2015-06
• Primary Completion: 2015-06
• Study Completion: 2015-06
• Study First Submitted: 2015-06-16
• Study First Submitted QC: 2015-06-16
• Study First Posted: 2015-06-19
• Status Verified: 2015-07
• Last Update Submitted: 2015-07-09
• Last Update Posted: 2015-07-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
accuracy value (Arms) for %SpO2 over the range of 70-100% in motion and non-motion	3 days

Trial Locations

Locations (1)

Clinimark; 🇺🇸 Louisville, Colorado, United States