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Status:

COMPLETED

SpO2 Hypoxia Accuracy Validation Study

Lead Sponsor:

Nonin Medical, Inc

Conditions:

Hypoxia

Eligibility:

All Genders

18-50 years

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 o...

Detailed Description

The primary objective of this study is to evaluate the %SpO2 accuracy of a combined pulse oximetry system which consists of a Nonin sensor ), an adaptor cable, and an oximetry system during non-motion...

Eligibility Criteria

Inclusion

  • 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.

Exclusion

  • 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.

Key Trial Info

Start Date :

November 1 2017

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

November 3 2017

Estimated Enrollment :

12 Patients enrolled

Trial Details

Trial ID

NCT03348189

Start Date

November 1 2017

End Date

November 3 2017

Last Update

November 20 2017

Active Locations (1)

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Page 1 of 1 (1 locations)

1

Clinimark

Louisville, Colorado, United States, 80027