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SpO2 Hypoxia Accuracy Validation Study

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ClinicalTrials.gov Identifier: NCT03348189
Recruitment Status : Completed
First Posted : November 20, 2017
Last Update Posted : November 20, 2017
Sponsor:
Information provided by (Responsible Party):
Nonin Medical, Inc

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.

Condition or disease Intervention/treatment
Hypoxia Other: Pulse Oximeter

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 conditions.

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Study Type : Observational
Actual Enrollment : 12 participants
Observational Model: Other
Time Perspective: Other
Official Title: SpO2 Hypoxia Accuracy Validation Study
Actual Study Start Date : November 1, 2017
Actual Primary Completion Date : November 3, 2017
Actual Study Completion Date : November 3, 2017

Group/Cohort Intervention/treatment
Observational
Healthy males and females
Other: Pulse Oximeter
Pulse Oximeter




Primary Outcome Measures :
  1. SpO2 Hypoxia Accuracy Validation Study [ Time Frame: Through study completion, 3 months average ]
    Values from the test device will be compared to the values from co-oximetry to determine accuracy of the test device.



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Criteria

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 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 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, 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03348189


Locations
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United States, Colorado
Clinimark
Louisville, Colorado, United States, 80027
Sponsors and Collaborators
Nonin Medical, Inc
Investigators
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Study Director: Dena Raley Clinimark, LLC

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Responsible Party: Nonin Medical, Inc
ClinicalTrials.gov Identifier: NCT03348189     History of Changes
Other Study ID Numbers: QATP3093
First Posted: November 20, 2017    Key Record Dates
Last Update Posted: November 20, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Hypoxia
Signs and Symptoms, Respiratory
Signs and Symptoms