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Completed

NCT Number: NCT02475668

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

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

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Key information

Conditions

Hypoxia Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Respiratory

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Clinimark

Louisville, Colorado, 80027, United States

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pulse Oximeter

Device

Hypoxia

Primary outcomes

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

    Time frame: 3 days

Sponsors and collaborators

Lead sponsor

Nonin Medical, Inc

Industry

Collaborators

  • Clinimark, LLC

Registry information

Official study title

SpO2 Accuracy Validation of Pulse Oximetry Systems During Motion and Non-Motion Conditions of Induced Hypoxia as Compared to Arterial Blood CO-Oximetry

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Jun 19, 2015
Registry last updated
Jul 10, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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