SpO2 Hypoxia Accuracy Validation Study

NCT03348189 | Completed

• 1 other identifier: QATP3093
• Study Type: observational
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hypoxia

Outcome Measures

Primary Outcomes (1)

• SpO2 Hypoxia Accuracy Validation Study

  Values from the test device will be compared to the values from co-oximetry to determine accuracy of the test device.

  Through study completion, 3 months average

Study Arms (1)

Observational

Healthy males and females

Other: Pulse Oximeter

Interventions

Pulse Oximeter OTHER

Pulse Oximeter

Observational

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

A minimum of 12 subjects will be enrolled. The subject population will include both male and female subjects with a variety of skin tones.

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.

Sponsors & Collaborators

• Nonin Medical, Inc: lead

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

• Dena Raley

  Clinimark, LLC

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: November 15, 2017
• First Posted: November 20, 2017
• Study Start: November 1, 2017
• Primary Completion: November 3, 2017
• Study Completion: November 3, 2017
• Last Updated: November 20, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)