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

NCT02475668 | Completed

• 1 other identifier: QATP2759
• Study Type: observational
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hypoxia

Outcome Measures

Primary Outcomes (1)

• accuracy value (Arms) for %SpO2 over the range of 70-100% in motion and non-motion

  3 days

Interventions

Pulse oximeter DEVICE

Hypoxia

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Healthy volunteers

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 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.

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 (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

Sponsors & Collaborators

• Nonin Medical, Inc: lead
• Clinimark, LLC: collaborator

Study Sites (1)

Clinimark

Louisville, Colorado, 80027, United States

Location

MeSH Terms

Conditions

Hypoxia

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Dave Ransom, MD

  Avista Adventis Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2015
• First Posted: June 19, 2015
• Study Start: June 1, 2015
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: July 10, 2015

Record last verified: 2015-07

Locations

US (1)